Focuses of this update are: equipment qualification, qualification and validation of computerised systems, and the ICH Guidelines Q3C and Q13

The following overview lists the topics covered with this Update:

GMP in Practice

Chapter 6 Qualification

• 6.J Example SOP for the qualification of equipment and machinery

Chapter 9 Computer System Validation

• 9.E Qualification and validation of computerised systems

Chapter 17 Outsourced Activities

• 17.A + 17.B Extras:
  • Quality Agreement
  • Technical Agreement and Delimitation of Pharmaceutical Responsibilities
  • GMP-Questionnaire: Contract manufacturing/Contract analysis

GMP Regulations

Chapter C EU Directives and Guidelines

• C.19 Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

Chapter E ICH Guidelines

• E.3.C ICH Q3C(R8): Impurities: Guideline for Residual Solvents
• E.13 ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products

Chapter F PIC/S Guidelines

• F.9–F.12 PIC/S GMP Guide PE 009-16:
  • F.9 PIC/S GMP Guide PE 009-16 Intro
  • F.10 PIC/S GMP Guide PE 009-16 Part I
  • F.11 PIC/S GMP Guide PE 009-16 Part II
  • F.12 PIC/S GMP Guide PE 009-16 Annexes

Focuses of this update are: outsourced manufacturing and testing activities, GMP certificates for APIs and GMPs for biotechnological APIs

The following overview lists the topics covered with this Update:

GMP in Practice

Chapter 1 Quality Management Systems

• 1.L Outsourced activities

Chapter 20 Active Pharmaceutical Ingredients

• 20.D GMP Certificates
• 20.G Biotechnological active substances

GMP Regulations

Chapter C EU Directives and Guidelines

• C.8.2.1 Safety features for medicinal products for human use Questions and Answers – Version 20
• C.19 Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

New: EU Annex 1, FDA's OOS investigation, ICH Q3D, expert chapters on storage temperatures, environmental qualification and EU Annex 21

The following overview lists the topics covered with this Update:

Information

• GMP Abbreviations
• GMP Glossary

GMP in Practice

Chapter 0 Current topics

• 0.F Importation of medicinal products

Chapter 2 Personnel

• 2.D Hygiene requirements for personnel

Chapter 3 Premises

• 3.A Official requirements for premises

Chapter 16 Storage and transportation

• 16.F Standard storage at 15–25 °C? A case study challenging conventional limits

GMP Regulations

Chapter C EU Directives and Guidelines

• C.4.1.1 Annex 1 Manufacture of sterile medicinal products
  EXTRA: The Annex 1 Comparison from Draft to Final

Chapter D USA: CFR and FDA Guidelines

• D.9 Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Chapter E GMP of other regions

• E.3.D ICH Q3D (R2): Guideline for Elemental Impurities

The new or updated chapters provide a wealth of knowledge on: GMP for Cannabis products, IT systems for the optimisation of QM processes, validation of analytical methods and fight against counterfeit medicines.

The following overview lists the topics covered with this Update:

Information

• GMP Abbreviations
• GMP Glossary

GMP in Practice

Chapter 0 Current Topics

• 0.B.2 Medical Cannabis and GMP: 6 Keys to Focus on

Chapter 1 Quality Management Systems

• 1.H IT Systems for the Optimisation of Quality Management Processes

Chapter 14 Laboratory Controls

• 14.D Validation of analytical methods

Chapter 21 Inspections and drug safety

• 21.H Fight against counterfeit medicines

GMP Regulations

Chapter C EU Directives and Guidelines    

• C.8 Directive 2001/83/EC – medicinal products for human use
• C.19 Q&A for MAHs on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 – nitrosamine impurities in human medicinal products, Rev. 11

The following overview lists the topics covered with this Update:

Information

• GMP Abbreviations
• GMP Glossary

GMP in Practice

Chapter 2 Personnel

• 2.E Function owners

Chapter 5 Pharmaceutical Water

• 5.A Water qualities
• 5.B Pharmaceutical Water Generation
• 5.D Qualification of water supply systems

GMP Regulations

Chapter C EU Directives and Guidelines

• C.7 Compilation of Union Procedures on Inspections and Exchange of Information
• C.10 EU Directives on Medical Devices
• C.10.2 Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU IVDR)

Chapter G GMP of other Regions

G.2 Canadian Regulations:

• G.2.1 Good manufacturing practices guide for drug products (GUI-0001)
• G.2.2 Annexes to GUI-0001
• G.2.2.1 Annex 7 to the Good manufacturing practices guide for drug products – Selected non-prescription drugs (GUI-0066)

G.6 Australian Regulations:

• G.6.3 Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products
• G.6.4 GMP clearance guidance

The following overview lists the topics covered with this Update:

Information

• GMP Abbreviations
• GMP Glossary

GMP in Practice

Chapter 1 Quality Management Systems

• 1.I Batch Record Review
• 1.J Product Quality Review and AnnualProduct Review

Chapter 12 Sterile Production

• 12.H Testing for Endotoxins

GMP Regulations

Chapter C EU Directives and Guidelines

• C.2.1 Commission Directive (EU) 2017/1572
• C.2.2 Commission Delegated Regulation (EU) 2017/1569
• C.2.3 Commission Directive 91/412/EEC
• C.4.13 Annex 13: Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
• C.4.21 Annex 21: Importation of medicinal products

Chapter D CFR and FDA Guidelines

• D.1.1 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
• D.1.2 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
• D.1.3 21 CFR Part 11 Electronic Records; Electronic Signatures
• D.1.4 21 CFR Part 820 Quality System Regulation
• D.1.5 21 CFR Part 4 Regulation of Combination Products
• D.1.6 21 CFR Part 600 Biological Products:General
• D.1.7 21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components
• D.1.8 21 CFR Part 680 Additional Standards for Miscellaneous Products
• D.1.9 21 CFR Part 601 Licensing

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

Chapter 0 Current topics

• 0.A.5 Nitrosamines in medicinal products: relevant in development, marketing authorisation, quality control and supervision

Chapter 4 Facilities and Equipment

• 4.H Cleaning of facilities

Chapter 9 Computer System Validation

• 9.B Regulatory requirements for computerised systems and the validation process

Chapter 15 Documentation

• 15.D Standard Operating Procedures (SOPs)

GMP Regulations

Chapter C EU Directives and Guidelines

• C.7 Compilation of Union Procedures on Inspections and Exchange of Information – Introduction and History of changes to the Compilation of Procedures
• C.8.2.1 Safety features for medicinal products for human use Questions and Answers – Version 19
• C.9 Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC
• C.19 Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

Please note:

Based on an analysis of user behaviour, we have made the following changes to the structure of the GMP Compliance Adviser:

• Chapter 20 Continual Improvement has been removed.
• Subchapter 20.E on failure management moved to 1.N.
• Chapter 21 APIs moved to Chapter 20.
• Chapter 21 features the new topic inspections and drug safety.
• Parts of Chapter 18 moved to Chapter 21, while others were temporarily removed.
• Chapter 18 will be filled with new topics in future.

The following overview lists the topics covered with this Update:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

General Information

Authors

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser Update you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP Regulations

With this GMP Compliance Adviser Update you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP Regulations

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations

With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

GMP Regulations