Are you over 18 and want to see adult content?
More Annotations
A complete backup of cardinaluniformsandscrubs.com
Are you over 18 and want to see adult content?
A complete backup of taylorsvilletimes.com
Are you over 18 and want to see adult content?
A complete backup of jobapplicationcenter.com
Are you over 18 and want to see adult content?
Favourite Annotations
A complete backup of auchipoly.edu.ng
Are you over 18 and want to see adult content?
A complete backup of hercuriomajesty.com
Are you over 18 and want to see adult content?
A complete backup of fractalfoundation.org
Are you over 18 and want to see adult content?
A complete backup of catalinajazzclub.com
Are you over 18 and want to see adult content?
A complete backup of otakuusamagazine.com
Are you over 18 and want to see adult content?
A complete backup of gesaenerji.com.tr
Are you over 18 and want to see adult content?
Text
process 126
NEWS - PIC/S
The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides. To download the revised GMP Guide (PE 009-15), please consult the page GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN PI 041-1 (Draft 3) 4 of 52 30 November 2018 119 2.6 The responsibility for good practices regarding data management and integrity lies 120 PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN … PI 011-3 Page 1 of 50 25 September 2007 1. DOCUMENT HISTORY Adoption by PIC/S Committee 2-3 June 2003 Entry into force 1 September 2003 ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY … PI 014-3 Page 4 of 20 25 September 2007 6. PRINCIPLES RELATED TO THE SELECTION AND USE OF ISOLATORS SUBJECTED TO A SPORICIDAL PROCESS. 6.1 The application of these principles to isolators used for sterilitytesting may be
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
NEWS - PIC/S
The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides. To download the revised GMP Guide (PE 009-15), please consult the page GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN PI 041-1 (Draft 3) 4 of 52 30 November 2018 119 2.6 The responsibility for good practices regarding data management and integrity lies 120 PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN … PI 011-3 Page 1 of 50 25 September 2007 1. DOCUMENT HISTORY Adoption by PIC/S Committee 2-3 June 2003 Entry into force 1 September 2003 ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY … PI 014-3 Page 4 of 20 25 September 2007 6. PRINCIPLES RELATED TO THE SELECTION AND USE OF ISOLATORS SUBJECTED TO A SPORICIDAL PROCESS. 6.1 The application of these principles to isolators used for sterilitytesting may be
PIC/S
PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. More about PIC/S.NEWS - PIC/S
The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides. To download the revised GMP Guide (PE 009-15), please consult the page INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS … PI 010-5 Page 3 of 10 1 July 2017 2.6 This SOP is in line with the EU document “Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects”, as contained in the Compilation of PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human usePIC/S GDP GUIDE
PE 011-1 Page 4 of 27 1 June 2014 DOCUMENT HISTORY Adoption by the PIC/S Committee 15-16 May 2014 Entry into force 1 June 2014INTRODUCTION
ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY … PI 014-3 Page 4 of 20 25 September 2007 6. PRINCIPLES RELATED TO THE SELECTION AND USE OF ISOLATORS SUBJECTED TO A SPORICIDAL PROCESS. 6.1 The application of these principles to isolators used for sterilitytesting may be
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
NEWS - PIC/S
The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides. To download the revised GMP Guide (PE 009-15), please consult the page GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN PI 041-1 (Draft 3) 4 of 52 30 November 2018 119 2.6 The responsibility for good practices regarding data management and integrity lies 120 GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN … PI 011-3 Page 1 of 50 25 September 2007 1. DOCUMENT HISTORY Adoption by PIC/S Committee 2-3 June 2003 Entry into force 1 September 2003 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
NEWS - PIC/S
The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides. To download the revised GMP Guide (PE 009-15), please consult the page GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN PI 041-1 (Draft 3) 4 of 52 30 November 2018 119 2.6 The responsibility for good practices regarding data management and integrity lies 120 GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN … PI 011-3 Page 1 of 50 25 September 2007 1. DOCUMENT HISTORY Adoption by PIC/S Committee 2-3 June 2003 Entry into force 1 September 2003PIC/S
PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. More about PIC/S.NEWS - PIC/S
The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides. To download the revised GMP Guide (PE 009-15), please consult the page INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS … PI 010-5 Page 3 of 10 1 July 2017 2.6 This SOP is in line with the EU document “Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects”, as contained in the Compilation of PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human usePIC/S GDP GUIDE
PE 011-1 Page 4 of 27 1 June 2014 DOCUMENT HISTORY Adoption by the PIC/S Committee 15-16 May 2014 Entry into force 1 June 2014INTRODUCTION
ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY … PI 014-3 Page 4 of 20 25 September 2007 6. PRINCIPLES RELATED TO THE SELECTION AND USE OF ISOLATORS SUBJECTED TO A SPORICIDAL PROCESS. 6.1 The application of these principles to isolators used for sterilitytesting may be
PIC/SMEMBERSNEWSF.A.QNEWSLETTERSEACHABOUT PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. More about PIC/S.PUBLICATIONS
Publications. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringentmanufacturing and
GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
PIC/S INSPECTION REPORT FORMAT PI 013-3 Page 2 of 2 25 September 2007 4. SCOPE 4.1 This SOP is for use by non-EC members of PIC/S. However, alternative formats (e.g used by EU Members) that contain equivalent information may be PE 008-4 SITE MASTER FILE PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / PI 006-3 RECOMMENDATION ON VALIDATION MASTER PLAN PI 006-3 Page 3 of 26 25 September 2007 2.5.6 It is a requirement of GMP that each pharmaceutical company identifies what qualification and validation work is required to prove control of the critical MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use PIC/SMEMBERSNEWSF.A.QNEWSLETTERSEACHABOUT PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. More about PIC/S.PUBLICATIONS
Publications. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringentmanufacturing and
GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
PIC/S INSPECTION REPORT FORMAT PI 013-3 Page 2 of 2 25 September 2007 4. SCOPE 4.1 This SOP is for use by non-EC members of PIC/S. However, alternative formats (e.g used by EU Members) that contain equivalent information may be PE 008-4 SITE MASTER FILE PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / PI 006-3 RECOMMENDATION ON VALIDATION MASTER PLAN PI 006-3 Page 3 of 26 25 September 2007 2.5.6 It is a requirement of GMP that each pharmaceutical company identifies what qualification and validation work is required to prove control of the critical MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human usePIC/S
PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. More about PIC/S.PUBLICATIONS
Publications. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringentmanufacturing and
MEMBERS - PIC/S
3-3-2 Kasumigaseki Chiyoda-ku. JP - 100-0013 Tokyo. * Japan's Ministry of Health, Labour and Welfare (MHLW) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) count as one PIC/S Participating Authority. The Japanese Prefectures are represented by MHLW. Accessionto PIC
NEWS - PIC/S
The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides. To download the revised GMP Guide (PE 009-15), please consult the page VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 PRODUCTS … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
GUIDELINE ON SETTING HEALTH BASED EXPOSURE LIMITS FOR … 2.1 When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern. Medicinal products provide a GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICE guidelines on the principles of good distribution practice of active substances for medicinal products for human use GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN PI 041-1 (Draft 3) 4 of 52 30 November 2018 119 2.6 The responsibility for good practices regarding data management and integrity lies 120 GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP PI 011-3 Page 1 of 50 25 September 2007 1. DOCUMENT HISTORY Adoption by PIC/S Committee 2-3 June 2003 Entry into force 1 September 2003 PIC/SMEMBERSNEWSF.A.QNEWSLETTERSEACHABOUT PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. More about PIC/S.PUBLICATIONS
Publications. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringentmanufacturing and
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
PIC/S INSPECTION REPORT FORMAT PI 013-3 Page 2 of 2 25 September 2007 4. SCOPE 4.1 This SOP is for use by non-EC members of PIC/S. However, alternative formats (e.g used by EU Members) that contain equivalent information may be VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PE 008-4 SITE MASTER FILE PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / PI 006-3 RECOMMENDATION ON VALIDATION MASTER PLAN PI 006-3 Page 3 of 26 25 September 2007 2.5.6 It is a requirement of GMP that each pharmaceutical company identifies what qualification and validation work is required to prove control of the critical MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
PIC/SMEMBERSNEWSF.A.QNEWSLETTERSEACHABOUT PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. More about PIC/S.PUBLICATIONS
Publications. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringentmanufacturing and
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
PIC/S INSPECTION REPORT FORMAT PI 013-3 Page 2 of 2 25 September 2007 4. SCOPE 4.1 This SOP is for use by non-EC members of PIC/S. However, alternative formats (e.g used by EU Members) that contain equivalent information may be VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PE 008-4 SITE MASTER FILE PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / PI 006-3 RECOMMENDATION ON VALIDATION MASTER PLAN PI 006-3 Page 3 of 26 25 September 2007 2.5.6 It is a requirement of GMP that each pharmaceutical company identifies what qualification and validation work is required to prove control of the critical MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
PIC/S
New PIC/S Chairperson. 11 - 12 November 2019. New PIC/S Chairperson (2020-21), Ms Anne Hayes (Ireland / HPRA), elected at Committee meeting of 11-12 November 2019, welcomed by preceding PIC/S Chairman (2018-2019), Mr Boon Meow Hoe (Singapore / HSA).PUBLICATIONS
Publications. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringentmanufacturing and
MEMBERS - PIC/S
3-3-2 Kasumigaseki Chiyoda-ku. JP - 100-0013 Tokyo. * Japan's Ministry of Health, Labour and Welfare (MHLW) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) count as one PIC/S Participating Authority. The Japanese Prefectures are represented by MHLW. Accessionto PIC
MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 PRODUCTS … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
PI 012-3 RECOMMENDATION ON STERILITY TESTING PI 012-3 Page 4 of 11 25 September 2007 8.1.1.2 The test environment, which includes the laminar airflow cabinet or isolator, should be certified at least annually by a PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS … PI 010-5 Page 3 of 10 1 July 2017 2.6 This SOP is in line with the EU document “Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects”, as contained in the Compilation ofPIC/S GDP GUIDE
PE 011-1 Page 4 of 27 1 June 2014 DOCUMENT HISTORY Adoption by the PIC/S Committee 15-16 May 2014 Entry into force 1 June 2014INTRODUCTION
GUIDELINE ON SETTING HEALTH BASED EXPOSURE LIMITS FOR … 2.1 When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern. Medicinal products provide a GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP PI 011-3 Page 1 of 50 25 September 2007 1. DOCUMENT HISTORY Adoption by PIC/S Committee 2-3 June 2003 Entry into force 1 September 2003 ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY … PI 014-3 Page 4 of 20 25 September 2007 6. PRINCIPLES RELATED TO THE SELECTION AND USE OF ISOLATORS SUBJECTED TO A SPORICIDAL PROCESS. 6.1 The application of these principles to isolators used for sterilitytesting may be
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PI 023-2 INSPECTION OF QUALITY CONTROL LABORATORIES PI 023-2 Page 2 of 2 25 September 2007 4. SCOPE 4.1. This document applies to laboratories for testing of the finished medicinal products, intermediates, starting materials for the production ofmedicinal
PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’.PIC/S GDP GUIDE
PE 011-1 Page 4 of 27 1 June 2014 DOCUMENT HISTORY Adoption by the PIC/S Committee 15-16 May 2014 Entry into force 1 June 2014INTRODUCTION
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN PI 041-1 (Draft 3) 4 of 52 30 November 2018 119 2.6 The responsibility for good practices regarding data management and integrity lies 120 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PI 023-2 INSPECTION OF QUALITY CONTROL LABORATORIES PI 023-2 Page 2 of 2 25 September 2007 4. SCOPE 4.1. This document applies to laboratories for testing of the finished medicinal products, intermediates, starting materials for the production ofmedicinal
PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’.PIC/S GDP GUIDE
PE 011-1 Page 4 of 27 1 June 2014 DOCUMENT HISTORY Adoption by the PIC/S Committee 15-16 May 2014 Entry into force 1 June 2014INTRODUCTION
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN PI 041-1 (Draft 3) 4 of 52 30 November 2018 119 2.6 The responsibility for good practices regarding data management and integrity lies 120PIC/S
New PIC/S Chairperson. 11 - 12 November 2019. New PIC/S Chairperson (2020-21), Ms Anne Hayes (Ireland / HPRA), elected at Committee meeting of 11-12 November 2019, welcomed by preceding PIC/S Chairman (2018-2019), Mr Boon Meow Hoe (Singapore / HSA). VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
INSPECTION OF BIOTECHNOLOGY MANUFACTURES PI 024-3 Page 3 of 13 1 January 2021 4. SCOPE 4.1 The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
PIC/S GDP GUIDE
PE 011-1 Page 4 of 27 1 June 2014 DOCUMENT HISTORY Adoption by the PIC/S Committee 15-16 May 2014 Entry into force 1 June 2014INTRODUCTION
PI 023-2 INSPECTION OF QUALITY CONTROL LABORATORIES PI 023-2 Page 2 of 2 25 September 2007 4. SCOPE 4.1. This document applies to laboratories for testing of the finished medicinal products, intermediates, starting materials for the production ofmedicinal
PI 006-3 RECOMMENDATION ON VALIDATION MASTER PLAN PI 006-3 Page 3 of 26 25 September 2007 2.5.6 It is a requirement of GMP that each pharmaceutical company identifies what qualification and validation work is required to prove control of the critical CROSS-CONTAMINATION IN SHARED FACILITIES PI 043-1 4 of 20 1 July 2018 . 2.4.5 That the mitigating technical and organisational controls are based on scientific knowledge and experience with the process. GUIDELINE ON SETTING HEALTH BASED EXPOSURE LIMITS FOR … 2.1 When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern. Medicinal products provide a ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY … PI 014-3 Page 4 of 20 25 September 2007 6. PRINCIPLES RELATED TO THE SELECTION AND USE OF ISOLATORS SUBJECTED TO A SPORICIDAL PROCESS. 6.1 The application of these principles to isolators used for sterilitytesting may be
INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF BIOTECHNOLOGY MANUFACTURES PI 024-3 Page 3 of 13 1 January 2021 4. SCOPE 4.1 The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy CROSS-CONTAMINATION IN SHARED FACILITIESCROSS CONTAMINATION IN FOOD SERVICECROSS CONTAMINATION IN HEALTH CARECROSS CONTAMINATION CDCCROSS CONTAMINATION EXAMPLESCROSS CONTAMINATION FOOD SAFETYCROSSCONTAMINATION PDF
PI 043-1 4 of 20 1 July 2018 . 2.4.5 That the mitigating technical and organisational controls are based on scientific knowledge and experience with the process. PE 008-4 SITE MASTER FILE PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIESEXAMPLES OF GMPSFDA GMP 117FDA GMP REGULATIONSWHAT IS GMP COMPLIANCEBOOKSTORE CLASSIFICATION CATEGORIESCLASSIFICATION CATEGORIES IN ORDER 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
PI 012-3 RECOMMENDATION ON STERILITY TESTING PI 012-3 Page 4 of 11 25 September 2007 8.1.1.2 The test environment, which includes the laminar airflow cabinet or isolator, should be certified at least annually by a GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN … PI 011-3 Page 1 of 50 25 September 2007 1. DOCUMENT HISTORY Adoption by PIC/S Committee 2-3 June 2003 Entry into force 1 September 2003 INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing INSPECTION OF BIOTECHNOLOGY MANUFACTURES PI 024-3 Page 3 of 13 1 January 2021 4. SCOPE 4.1 The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy CROSS-CONTAMINATION IN SHARED FACILITIESCROSS CONTAMINATION IN FOOD SERVICECROSS CONTAMINATION IN HEALTH CARECROSS CONTAMINATION CDCCROSS CONTAMINATION EXAMPLESCROSS CONTAMINATION FOOD SAFETYCROSSCONTAMINATION PDF
PI 043-1 4 of 20 1 July 2018 . 2.4.5 That the mitigating technical and organisational controls are based on scientific knowledge and experience with the process. PE 008-4 SITE MASTER FILE PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIESEXAMPLES OF GMPSFDA GMP 117FDA GMP REGULATIONSWHAT IS GMP COMPLIANCEBOOKSTORE CLASSIFICATION CATEGORIESCLASSIFICATION CATEGORIES IN ORDER 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
PI 012-3 RECOMMENDATION ON STERILITY TESTING PI 012-3 Page 4 of 11 25 September 2007 8.1.1.2 The test environment, which includes the laminar airflow cabinet or isolator, should be certified at least annually by a GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN … PI 011-3 Page 1 of 50 25 September 2007 1. DOCUMENT HISTORY Adoption by PIC/S Committee 2-3 June 2003 Entry into force 1 September 2003PUBLICATIONS
Publications. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringentmanufacturing and
MEMBERS - PIC/S
3-3-2 Kasumigaseki Chiyoda-ku. JP - 100-0013 Tokyo. * Japan's Ministry of Health, Labour and Welfare (MHLW) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) count as one PIC/S Participating Authority. The Japanese Prefectures are represented by MHLW. Accessionto PIC
PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS … PI 010-5 Page 3 of 10 1 July 2017 2.6 This SOP is in line with the EU document “Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects”, as contained in the Compilation of GMP INSPECTION RELIANCE a) the facility is situated within the territory of a PIC/S Participating Authority; or b) the hosting NCA has been assessed, typically within the last 5 years utilising MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 PRODUCTS … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
NEWS - PIC/S
November 2020 Brazil / ANVISA joins PIC/S. Geneva, 30 November 2020 : The PIC/S Committee has invited Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to join the PIC Scheme.. Brazil / ANVISA will become PIC/S’ 54th Participating Authority as from 1 January 2021.ANVISA submitted a complete membership application inOctober 2014.
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
INSPECTION OF BIOTECHNOLOGY MANUFACTURES PI 024-3 Page 3 of 13 1 January 2021 4. SCOPE 4.1 The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing CROSS-CONTAMINATION IN SHARED FACILITIESCROSS CONTAMINATION IN FOOD SERVICECROSS CONTAMINATION IN HEALTH CARECROSS CONTAMINATION CDCCROSS CONTAMINATION EXAMPLESCROSS CONTAMINATION FOOD SAFETYCROSSCONTAMINATION PDF
PI 043-1 4 of 20 1 July 2018 . 2.4.5 That the mitigating technical and organisational controls are based on scientific knowledge and experience with the process. PE 008-4 SITE MASTER FILE PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIESEXAMPLES OF GMPSFDA GMP 117FDA GMP REGULATIONSWHAT IS GMP COMPLIANCEBOOKSTORE CLASSIFICATION CATEGORIESCLASSIFICATION CATEGORIES IN ORDER 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. PI 012-3 RECOMMENDATION ON STERILITY TESTING PI 012-3 Page 4 of 11 25 September 2007 8.1.1.2 The test environment, which includes the laminar airflow cabinet or isolator, should be certified at least annually by a INSPECTION OF UTILITIES pi 009-4 page 1 of 10 1 january 2021 pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pi 009-4 1january 2021
NEWS - PIC/S
November 2020 Brazil / ANVISA joins PIC/S. Geneva, 30 November 2020 : The PIC/S Committee has invited Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to join the PIC Scheme.. Brazil / ANVISA will become PIC/S’ 54th Participating Authority as from 1 January 2021.ANVISA submitted a complete membership application inOctober 2014.
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL Table of contents PE 009-15 (Annexes) -iv- 1 May 2021 Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 125 Introduction 125 Responsibilities 125 Dosimetry 126 Validation of theprocess 126
INSPECTION OF BIOTECHNOLOGY MANUFACTURES PI 024-3 Page 3 of 13 1 January 2021 4. SCOPE 4.1 The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy GMP GUIDE PART II APIS Introduction PE 009-15 (Part II) - 1 - 1 May 2021 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing CROSS-CONTAMINATION IN SHARED FACILITIESCROSS CONTAMINATION IN FOOD SERVICECROSS CONTAMINATION IN HEALTH CARECROSS CONTAMINATION CDCCROSS CONTAMINATION EXAMPLESCROSS CONTAMINATION FOOD SAFETYCROSSCONTAMINATION PDF
PI 043-1 4 of 20 1 July 2018 . 2.4.5 That the mitigating technical and organisational controls are based on scientific knowledge and experience with the process. PE 008-4 SITE MASTER FILE PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIESEXAMPLES OF GMPSFDA GMP 117FDA GMP REGULATIONSWHAT IS GMP COMPLIANCEBOOKSTORE CLASSIFICATION CATEGORIESCLASSIFICATION CATEGORIES IN ORDER 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. PI 012-3 RECOMMENDATION ON STERILITY TESTING PI 012-3 Page 4 of 11 25 September 2007 8.1.1.2 The test environment, which includes the laminar airflow cabinet or isolator, should be certified at least annually by aPUBLICATIONS
Publications. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/SMEMBERS - PIC/S
Spain. Spanish Agency of Medicines and Medical Devices* Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Departamento de Inspección y Control de Medicamentos C/ Campezo, 1 ES - 28022 Madrid * The competence for GMP/GDP inspections in Spain is shared between the central authority, Spanish Agency for Medicines and Medical Devices (AEMPS), and the Spanish regionalACCESSION - PIC/S
Accession. The Accession Procedure as such is a time-consuming exercise. This is due to the fact that it will take you some time to complete your application and provide all the necessary translations of the supporting documents. INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL PI 052-1 4 of 10 1 June 2020 5. Aide-memoire for Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality RiskManagement
VALIDATION OF ASEPTIC PROCESSES PI 007-6 Page 1 of 16 1 January 2011 1. DOCUMENT HISTORY Adoption by the PIC/S Committee 7 September 1999 Entry into force of version PR1/99 1 January 2000
PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES 2.1 This guidance is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and toestablish
GMP INSPECTION RELIANCE a) the facility is situated within the territory of a PIC/S Participating Authority; or b) the hosting NCA has been assessed, typically within the last 5 years utilising MANUFACTURE OF ADVANCED THERAPY MEDICINAL 4 PRODUCTS … Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use . 48 (b) Blood or blood components used as starting materials forATMPs, national law
PHARMACEUTICAL INSPECTION CONVENTION … PS/INF 20/2011 3 of 4 24 March 2011 Q7. Section 11.40 of GMP states that ‘authentic Certificates of Analysis (CoA) should be issued for each batch of intermediate or API on request’. GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human useMenu
* About
* Members
* Publications
* Activities
* Events
* Accession
* PIA Academy
* News
* F.A.Q.
* Newsletter
* Members Area Login* Seach
About
* Introduction
* Introduction (in French) * Mission, Vision and Values* History
* Benefits
* Organisational Structure * International Co-operation* Photogallery
* Videogallery
* Links
* List of Acronyms
* Copyright Disclaimer* Contact
Organisational Structure* Legal form
* Governance
* Committee
* Executive Bureau
* Secretariat
* Office Holders
International Co-operation * Associated Partner Organisations * Other Organisations * Professional Organisations & IndustryPhotogallery
* PIC/S 40th Anniversary * PIC/S-PDA Q7 Trainings * API Expert Circle meeting Strasbourg (France)Members
Activities
* GM(D)P Harmonisation* Training
* Compliance
* Expert Circles
* Strategic Development* Communication
* Budget, Risk and AuditEvents
Accession
* Accession Procedure* Applicants
* Pre-Applicants
* Former Pre-Applicants * Accession Requirements* Accession Contact
Accession Procedure
* Accession
* Pre-Accession
Picscheme
* News
* F.A.Q.
* Newsletter
* Members Area Login* Seach
__
* About
* Members
* Publications
* Activities
* Events
* Accession
* PIA Academy
PHARMACEUTICAL INSPECTIONCO-OPERATION SCHEME
Leading the international development, implementation and maintenanceof harmonised
GMP standards and quality systems of Inspectorates in the field ofmedicinal products
ACCESSION OF BRAZIL / ANVISA TO PIC/S1 January 2021
By written procedure completed on 27 November 2020, the PIC/S Committee invited Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to join the Scheme as from 1 January 2021. ANVISA will become PIC/S’ 54th Participating Authority.more
__
__
ACCESSION OF BRAZIL / ANVISA TO PIC/S1 January 2021
By written procedure completed on 27 November 2020, the PIC/S Committee invited Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to join the Scheme as from 1 January 2021. ANVISA will become PIC/S’ 54th Participating Authority.more
NEW PIC/S CHAIRPERSON 11 - 12 November 2019 New PIC/S Chairperson (2020-21), Ms Anne Hayes (Ireland / HPRA), elected at Committee meeting of 11-12 November 2019, welcomed by preceding PIC/S Chairman (2018-2019), Mr Boon Meow Hoe (Singapore /HSA).
ACCESSION OF ITALY (VETERINARY AGENCY) / DGSAF TO PIC/S 11 - 12 November 2019 At its meeting on 11-12 November 2019 in Toyama, the PIC/S Committee invited the Italian Veterinary Agency (DGSAF) to join the Scheme as from 1 January 2020. DGSAF will become PIC/S’ 53rd ParticipatingAuthority.
more
PIC/S COMMITTEE MEETING, NOVEMBER 2019 11 - 12 November 2019 PIC/S Committee meeting which took place in Toyama (Japan), on 11-12 November 2019, hosted by Japan / MHLW & PMDA.more
PIC/S SEMINAR 2019
13 - 15 November 2019 Participants attending the PIC/S 2019 Seminar on "Quality Assurance of Sterile Medicinal Products - Annex 1" which took place in Toyama (Japan) on 13-15 November 2019, hosted by Japan / MHLW & PMDAmore
PIC/S SEMINAR 2019
13 - 15 November 2019 Opening of PIC/S 2019 Seminar on "Quality Assurance of Sterile Medicinal Products - Annex 1" which took place in Toyama (Japan) on 13-15 November 2019, hosted by Japan / MHLW & PMDAmore
ABOUT
*
PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together inparallel.
* More about PIC/S
NEWS & EVENTS
* Revision of PIC/S GMP Guide (PE 009-15) * Revision of PIC/S Blood Guidance Documents (PE 005-4 and PI 008-4) * PIC/S Virtual Seminar 2021News
Events
PIA ACADEMY
The PIC/S Inspectorates' Academy (PIA) is a PIC/S initiative to set up a web-based educational centre under the PIC/S umbrella which aims at harmonising and standardising GMP training at an international level. It's motto is "INSPECTION EXCELLENCE THROUGH HARMONISED TRAINING"more
LATEST PUBLICATIONS
* PIC/S Aide Memoire to Inspections of Blood Establishments andPlasma Warehouses
* PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks * PIC/S GMP Guide (Related Annexes)All publications
CURRENT ACTIVITIES
* GM(D)P Harmonisation* Compliance
* Training
* Strategic Development* Expert Circles
* Communication
* Budget, Risk and AuditAll topics
NEWSLETTER
Subscribe now to our Newsletter to be kept up-to-date with whathappens at PIC/S...
PHOTOS > ALL PHOTOS
MEMBERS
There are currently 54 PIC/S Participating Authorities worldwide,including:
* About Introduction Introduction (in French) Mission, Vision and ValuesHistory
Benefits
Organisational Structure International Co-operationPhotogallery
Videogallery
Links
List of Acronyms
Copyright DisclaimerContact
* Members
* Publications
* Activities GM(D)P HarmonisationTraining
Compliance
Expert Circles
Strategic DevelopmentCommunication
Budget, Risk and Audit* Events
* Accession Accession ProcedureApplicants
Pre-Applicants
Former Pre-Applicants Accession RequirementsAccession Contact
* PIA Academy
Contact
PIC/S Secretariat
14, rue du Roveray CH1207 Geneva
Switzerland
Tel: (+41) 22 738 92 16 Email: info@picscheme.orgFollow us
__
Details
Copyright © 2024 ArchiveBay.com. All rights reserved. Terms of Use | Privacy Policy | DMCA | 2021 | Feedback | Advertising | RSS 2.0