03.08.2023
GMP Compliance Adviser Update No 4/2023
Hot topics: sampling and analytical procedures for cleaning validation, requirements and expectations for qualification, revised ICH Q9 in force
The following overview lists the topics covered with this Update:
GMP in Practice
Chapter 6 Qualification
- 6.A Official requirements and agency expectations for qualification
Chapter 8 Cleaning Validation
- 8.F Sampling procedures
- 8.G Analytical procedures
The revision of Annex 1 and editorial corrections resulted in minor changes in the following chapters:
- 3.G Building services
- 5.C Distribution and storage of pharmaceutical water
- 5.G Monitoring Pharmaceutical Water
- 6.G Performance Qualification (PQ)
GMP Regulations
Chapter C EU Directives and Guidelines
- C.3.3.2 ICH Guideline Q9(R1) on Quality Risk Management
- 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 re-ferral on nitrosamine impurities in human medicinal products
Chapter E ICH Guidelines
- E.9 ICH Q9 (R1): Quality Risk Management
Chapter H WHO Guidelines
- H.5 WHO good manufacturing practices for sterile pharmaceutical products (Technical Report Series, No. 1044 (2022), Annex 2)
- H.6 WHO guidelines on technology transfer in pharmaceutical manufacturing (Technical Report Series, No. 1044 (2022), Annex 4)
- H.9 WHO: Guidelines on good manufacturing practices for the manufacture of herbal medicines (Technical Report Series, No. 1010 (2018), Annex 2)
- H.10 WHO: International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products (Technical Report Series, No. 1025 (2020), Annex 2)
31.05.2023
GMP Compliance Adviser Update No 3/2023
Hot topic Contamination Control Strategy CCS: everything you need to know about the content, preparation and implementation of the CCS
The following overview lists the topics covered with this Update:
GMP in Practice
Chapter 3 Premises
- 3.K Pharma monitoring of HVAC systems
Chapter 12 Sterile Production
- 12.B Contamination Control Strategy (CCS)
Chapter 16 Storage and Transportation
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 re-ferral on nitrosamine impurities in human medicinal products
Chapter D USA: CFR and FDA Guidelines
- D.1 Code of Federal Regulations
- 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
06.04.2023
GMP Compliance Adviser Update No 2/2023
Already includes new Annex 1 requirements: updated chapters on cleanrooms and pharmaceutical water systems.
The following overview lists the topics covered with this Update:
GMP in Practice
Chapter 3 Premises
Chapter 5 Pharmaceutical Water
08.02.2023
GMP Compliance Adviser Update No 1/2023
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
Chapter 9 Computer System Validation
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
Chapter E ICH Guidelines
Chapter F PIC/S Guidelines
08.12.2022
GMP Compliance Adviser Update No 6/2022
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
Chapter 20 Active Pharmaceutical Ingredients
GMP Regulations
Chapter C EU Directives and Guidelines
20.10.2022
GMP Compliance Adviser Update No 5/2022
09.08.2022
GMP Compliance Adviser Update No 4/2022
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 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
09.06.2022
GMP Compliance Adviser Update No 3/2022
The following overview lists the topics covered with this Update:
Information
GMP in Practice
Chapter 2 Personnel
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
14.04.2022
GMP Compliance Adviser Update No 2/2022
The following overview lists the topics covered with this Update:
Information
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
17.02.2022
GMP Compliance Adviser Update No 1/2022
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
02.12.2021
GMP Compliance Adviser Update No. 6/2021
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 15
Documentation
|
15.A Official Requirements
15.B GMP-compliant documentation
15.G Document Management Systems
15.I GMP-compliant archiving
|
|
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 D
USA: CFR and FDA Guidelines
|
D.21 Guidance for Industry: Questions and Answers on Biosimilar Development and the BPCI Act
|
|
Chapter F
PIC/S Guidelines
|
F.28 PI 041-1: PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
|
|
Chapter H
WHO Guidelines
|
|
H.4 WHO Expert Committee on Specifications for Pharmaceutical Preparations: Good manufacturing practices: water for pharmaceutical use (Technical Report Series, No. 1033 (2021), Annex 3)
H.17 WHO Guideline on data integrity (Technical Report Series, No.1033 (2021), Annex 4)
|
|
04.10.2021
GMP Compliance Adviser Update No. 5/2021
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 9
Computer System Validation
|
9.H Validation of Excel applications
|
|
|
Chapter 20
Active Pharmaceutical Ingredients
|
20.C Marketing authorisation documentation for active substances
20.F Chemical active substances
|
|
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.20 Guideline on quality documentation for medicinal products when used with a medical device
|
|
Chapter G
GMP of other Regions
Health Canada
|
G.2.2.1 Annex 7 to the Good manufacturing practices guide for drug products – Selected non-prescription drugs (GUI-0066)
|
02.08.2021
GMP Compliance Adviser Update No. 4/2021
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
|
Current topics
|
0.A.4 Nitrosamine impurity risk assessment
0.D.1 Remote, distance, offsite or virtual audits? – What is GMP compliant and what is reasonable?
|
|
|
Chapter 14
Laboratory Controls
|
14.E Stability testing
|
|
|
Chapter 21
Inspections and drug safety
|
21.H Fight against counterfeit medicines |
|
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.8.2.1 Safety features for medicinal products for human use Questions and Answers – Version 18B
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
|
11.06.2021
GMP Compliance Adviser Update No. 3/2021
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 9
Computer System Validation
|
9.C System life cycle
9.D System classification and risk management
9.G External service providers
|
|
|
Chapter 21
Inspections and drug safety
|
21.D Preparing for GMP inspections
|
|
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.10.1 Regulation (EU) 2017/745 onmedicaldevices (EU MDR)
|
|
Chapter D
USA: 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
|
|
Chapter E
ICH Guidelines
|
E.3.C ICH Q3C(R8): Impurities: Guideline for Residual Solvents
|
|
Chapter F
PIC/S Guidelines
|
F.9 PIC/S PE 009-15: Guide to Good Manufacturing Practice forMedicinal Products – Intro
F.10 PIC/S PE 009-15: Guide to Good Manufacturing Practice for Medicinal Products – Part I
F.11 PIC/S PE 009-15: Guide to Good Manufacturing Practice for Medicinal Products – Part II
F.12 PIC/S PE 009-15: Guide to Good Manufacturing Practice for Medicinal Products – Annexes
|
15.04.2021
GMP Compliance Adviser Update No. 2/2021
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
|
Current Topics
|
0.C ATMPs
|
|
|
Chapter 17
Contractors and Suppliers
|
17.D Qualification of suppliers
|
|
|
Chapter 18 Audits
|
18.A Principles
18.B Audit management
18.C Audit preparation
18.D Audit execution
18.E Audit follow-up
18.F Requirements for auditors
18.G Special considerations depending on the auditee
18.H Third-party audits and shared audits
|
|
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.8 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
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 D
USA: CFR and FDA Guidelines
|
D.27 Control of Nitrosamine Impurities in Human Drugs
|
|
Chapter F
PIC/S Guidelines
|
F.6 PIC/S PI 009-4: Aide mémoire Inspection of Utilities
F.7 PIC/S PI 028-2: Aide-mémoire GMP Inspection Related to Packaging
F.14 PIC/S PI 038-2: Aide-mémoire Assessment of Quality Risk Management Implementation
F.20 PIC/S PI 024-3: Aide-Mémoire Inspection of Biotechnology Manufactures
|
12.02.2021
GMP Compliance Adviser Update No. 1/2021
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
|
Current Topics
|
0.B Cannabis
|
|
|
Chapter 1
Quality Management Systems
|
1.E Deviation management
|
|
|
Chapter 21
Inspections and drug safety
|
21.B Dealing with drug risks and GMP violations |
|
GMP Regulations
|
Chapter F
PIC/S Guidelines
|
F.27 PI 040-1: PIC/S Guidance on Classification of GMP Deficiencies
|
|
Chapter H
WHO Guidelines
|
H.13 WHO: Good storage and distribution practices for medical products
(Technical Report Series, No. 1025 (2020), Annex 7)
|
03.12.2020
GMP Compliance Adviser Update No. 7/2020
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 Nitrosamines
0.A.1 Information on nitrosamine impurities
0.A.2 Nitrosamine impurities in medicines: What
have we learned? – EMA report 2020
0.A.3 Unpacking FDA's new guidance on controlling
nitrosamine impurities in drugs
|
|
|
Chapter 4
Facilities and Equipment
|
4.I Containment (personnel protection) for APIs,
solid oral dosage forms and bio-pharmaceutical
products
|
|
|
Chapter 13
Packaging
|
13.B Packaging process |
|
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.8.2.1 Safety features for medicinal products for human use – Questions and Answers – Version 18
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
|
15.10.2020
GMP Compliance Adviser Update No. 6/2020
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 20
Active Pharmaceutical Ingredients
|
20.B Regulatory principles
|
|
|
Chapter 21
Inspections and drug safety
|
21.B Official inspections
|
|
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.8.2.1 Safety features for medicinal products for human use – Questions and Answers – Version 18
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 D
USA: CFR and FDA Guidelines
|
D.27 Control of Nitrosamine Impurities in Human Drugs – Guidance for Industry
|
28.08.2020
GMP Compliance Adviser Update No. 5/2020
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 1
Quality Management Systems
|
1.O Regulatory compliance – how to optimize
|
|
|
Chapter 21
Inspections and drug safety
|
21.C Frequent deficiencies in GMP inspections,
their recurring pitfalls and how to avoid them
21.E Self-inspection
|
|
Extras
|
|
|
Chapter 21
Inspections and drug safety
|
Analysis of FDA FY2019 Drug GMP Warning Letters |
|
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.11 Guideline on the quality of water for
pharmaceutical use
C.11.1 Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies
|
09.06.2020
GMP Compliance Adviser Update No. 4/2020
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
|
Chapter 4
Facilities and Equipment
|
4.C Hygienic Design
|
|
Chapter 20
Active
Pharmaceutical
Ingredients
|
20.A Introduction |
|
Chapter 21
Inspections
and drug safety
|
21.A Supervision of medicinal products in Europe |
GMP Regulations
|
Chapter D
USA: CFR and FDA Guidelines
|
D.1.4 21 CFR Part 820 Quality System Regulation (current as of April 2, 2020)
D.1.6 21 CFR Part 600 Biological Products: General (current as of April 1, 2020)
D.1.7 21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components
(current as of April 1, 2020)
D.1.8 21 CFR Part 680 Additional Standards for Miscellaneous Products (current as of April 1, 2020)
D.1.9 21 CFR Part 601 Licensing (current as of April 1, 2020)
|
29.04.2020
GMP Compliance Adviser Update No. 3/2020
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 19
Quality Risk Management
|
19.A Agency expectations of quality risk management
19.B Application and benefits of QRM in the pharmaceutical industry
19.C The quality risk management process
19.D Methods and tools of quality risk management
19.E Application examples for QRM in the pharmaceutical industry
19.F Examples for QRM in the GMP Compliance Adviser
19.G Definitions
|
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.4.1.1 Annex 1 – Second Draft, February 2020: Manufacture of Sterile Products
C.4.21 Draft Annex 21: Importation of medicinal products
C.8.2.1 Safety features for medicinal products for human use Questions and Answers – Version 17
|
06.03.2020
GMP Compliance Adviser Update No. 2/2020
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 3
|
3.J Qualification of premises and air handling technology
3.K Pharma monitoring of HVAC systems
|
| Chapter 16 |
16.L Monitoring |
GMP Regulations
|
Chapter C
EU Directives and Guidelines
|
C.10.2 ICH Q12: Regulation (EU) 2017/746 of the European Parliament and of the Council (EU IVDR) including Corrigendum 2, published on 27 December 2019
C.17 ATMPs: Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country
C.18 ATMPs: Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products
|
29.01.2020
GMP Compliance Adviser Update No. 1/2020
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 4
|
4.F Calibration (+++NEW version+++)
|
GMP Regulations
|
Chapter E
ICH Guidelines
|
E.12 ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
|
09.12.2019
GMP Compliance Adviser Update No. 8/2019
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 5
Pharmaceutical Water
+++REVISED+++
|
5.A Water qualities
5.B Pharmaceutical Water Generation
|
GMP Regulations
Chapter C
EU Directives and Guidelines
+++REVISED+++ |
C.10.1 Regulation (EU) 2017/745 of the European Parliament and of the Council (EU MDR)
|
Chapter H
WHO Guidelines
+++NEW+++ |
H.19.2 WHO: Guidelines on heating, vantilation and air-conditioning systems for non-sterile pharmaceutical products (Technical Report Series, No. 1019, 2019, Annex 2)
|
23.10.2019
GMP Compliance Adviser Update No. 7/2019
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
|
Chapter 24 becomes
Chapter 16
|
16.M Risk management in transportation
16.N Qualification of large-scale active systems (trailers)
16.O Qualification of passive insulation boxes
16.P Logistics service providers
16.Q Transport validation
16.S GDP inspections: Frequent deficiencies in the qualification of logistics service providers and how to avoid them (NEW)
|
GMP Regulations
Chapter C
(Revised) |
C.8.2.1 Safety features for medicinal products for human use Questions and Answers – Version 16
C.10.1 Regulation (EU) 2017/745 of the European Parliament and of the Council (EU MDR)
C.10.2 Regulation (EU) 2017/746 of the European Parliament and of the Council (EU IVDR)
|
Chapter E
(Revised) |
E.3.C ICH Q3C(R6): Impurities: Guideline for Residual Solvents
|
28.08.2019
GMP Compliance Adviser Update No. 6/2019
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:
| Chapter C |
C.2.1.1 Commission Directive (EU) 2017/1572
C.2.1.2 Commission Delegated Regulation (EU) 2017/1569
C.8.2.1 Safety features for medicinal products for human use Question and Answers – Version 15 |
16.08.2019
GMP Compliance Adviser Update No. 5/2019
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:
| Chapter 24 |
24.G The role of transport in ensuring the safety and quality of medicines
24.H Regulatory requirements for the transport of pharmaceuticals
24.I Transport conditions
24.J Transport vehicles and shipping containers
24.K Modes of transportation |
28.06.2019
GMP Compliance Adviser Update No. 4/2019
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:
| Chapter 14 |
14.C Qualification of laboratory equipment
14.K Pharmacopoeias
Please note: The order of the chapters 14.C-14.O has been changed for editorial reasons. |
| Chapter C |
C.16 Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container
|
| Chapter D |
D.1.1–D.1.9 21 CFRs 4, 11, 210, 211, 600, 601, 606, 680 and 820
D.19 Guidance for Industry: Considerations in Demonstrating Interchangeability with a ReferenceProduct
D.21 Guidance for Industry: Questions and Answers
|
| Chapter G |
G.2 Canadian Regulations
G.2.1 Good manufacturing practices guide fordrug products (GUI-0001)
G.2.2 Annexes to GUI-0001
|
09.05.2019
GMP Compliance Adviser Update No. 3/2019
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:
| Chapter 1 |
1.K.5 Serialisation of Folding Cartons in the Pharmaceutical Industry |
| Chapter 13 |
13.A.10 Pharmaceutical manufacturers and packaging suppliers: Ways to an improved dialogue
13.A.11 GMP aspects when handling print data
13.A.12 GMP aspects in the design of packaging materials
|
| Chapter C |
C.8.2.1 Safety features for medicinal products for human use – Questions and Answers - Version 14
|
| Chapter E |
E.3.D ICH Q3D (R1): Guideline for Elemental Impurities |
18.03.2019
GMP Compliance Adviser Update No. 2/2019
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:
| Chapter C |
C.8.2 Commission Delegated Regulation (EU) 2016/161
C.9 Directive 2001/82/EC of the EuropeanParliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
C.10.1 Regulation (EU) 2017/745 of the European Parliament and of the Council (EU MDR)
C.10.2 Regulation (EU) 2017/746 of the European Parliament and of the Council (EU IVDR)
|
| Chapter D |
D.22 Data Integrity and Compliance with Drug CGMP Questions and Answers Guidance for Industry
|
29.01.2019
GMP Compliance Adviser Update No. 1/2019
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:
| Chapter 3 |
3.C Airlock concepts (revised, formerly chapter 12.B)
3.E Cleanroom construction components (rewritten)
3.M Furniture and furnishings (new topic)
The sequence of chapters 3.A to 3.M has been changed for editorial reasons. |
30.11.2018
GMP Compliance Adviser Update No. 9/2018
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:
| Chapter 2 |
2.C Training Management (NEW)
The sequence of chapters 2.A to 2.E has been changed for editorial reasons. |
| Chapter 10 |
10.E Microbiological monitoring (NEW)
This chapter represents an up-to-date combination of the former chapters 11.E Environmental monitoring and 12.J Microbiological monitoring.
The new chapter 10.E Microbiological Monitoring combines all aspects related to sterile as well as non sterile preparations.
|
| Chapter 11 |
The content of chapter 11 Production has been separated:
The former chapters 11.A to 11.E now constitute the new chapter 10 Hygiene (see above).
The former chapters 11.F to 11.L can now be found in chapters 11.A to 11.G.
|
Chapter C
EU Directives and Guidelines |
C.5 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials combined with GMP for APIs: “How to do“ Document by APIC/CEFIC Interpretation of the ICHQ7 Guide |
|
Chapter E
ICH-Guidelines
|
E.3.C ICH Q3C(R7): Impurities: Guideline for Residual Solvents |
26.10.2018
GMP Compliance Adviser Update No. 8/2018
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:
| Note |
Chapter 1 Pharmaceutical Quality System (sections 1.A–1.I) has been completely replaced by a new chapter 1 Quality Management Systems (sections 1.A–1.N).
The new chapter includes the former content of chapter 19 Quality Unit and is completed by the following topics:
|
| Chapter 1 |
1.A Pharmaceutical quality system (PQS)
1.B The documentation of the pharmaceutical quality system (PQS)
1.H IT Systems for the Optimisation of Quality Management Processes |
| Chapter 19 |
The former content of chapter 19 Quality Unit has been relocated and is now part of the new chapter 1 Quality Management Systems.
The former content of chapter 10 Quality Risk Management is now provided in chapter 19 Quality Risk Management. |
| Chapter H |
H.19.1 WHO: Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (Technical Report Series, No. 1010 (2018), Annex 8) |
18.09.2018
GMP Compliance Adviser Update No. 7/2018
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:
| 4.E |
Technical documentation |
| 4.G |
Maintenance |
| 24.E |
Qualification of a cold-storage facility |
| 24.F |
Standard storage at 15-25°C? A case study challenging conventional limits |
| D.1.1 |
21 CFR Part 210 |
| D.1.2 |
21 CFR Part 211 |
| D.1.3 |
21 CFR Part 11 |
| D.1.4 |
21 CFR Part 820 |
| D.1.5 |
21 CFR Part 4 |
| D.1.6 |
21 CFR Part 600 |
| D.1.7 |
21 CFR Part 606 |
| D.1.8 |
21 CFR Part 680 |
| D.1.9 |
21 CFR Part 601 |
01.08.2018
GMP Compliance Adviser Update No. 6/2018
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:
| 5.A |
Water qualities |
| 5.B |
Pharmaceutical Water Generation |
| 14.O |
Elemental Impurities |
| C.6.2 |
Annex 2: Manufacture of Biological Active Substances and Medicinal Products for Human Use |
| C.6.17 |
Annex 17: Real Time Release Testing and Parametric Release |
29.06.2018
GMP Compliance Adviser Update No. 5/2018
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:
| 24.P |
GDP Audit Questionnaire for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices |
18.05.2018
GMP Compliance Adviser Update No. 4/2018
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:
| 14.N |
Determining and reporting numerical test results in pharmaceutical quality control |
| 15.D |
Standard Operating Procedures (SOPs) |
| C.5 |
EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials combined with GMP for APIs: “How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide |
| C.8.6.1 |
Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting healthbased exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/ SWP/169430/2012) |
18.04.2018
GMP Compliance Adviser Update No. 3/2018
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:
| 3.I |
Air Handling Technology |
06.03.2018
GMP Compliance Adviser Update No. 2/2018
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:
| 6.F |
Operational Qualification (OQ) |
| 6.G |
Performance Qualification (PQ) |
| E.12 |
Draft Version ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management |
06.02.2018
GMP Compliance Adviser Update No. 1/2018
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:
| C.6.1.1 |
Annex 1 – Draft: Manufacture of Sterile Medicinal Products |
| C.22 |
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products |
| D.26 |
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination |
18.12.2017
GMP Compliance Adviser Update No. 10/2017
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:
| 11.C |
Production hygiene |
| 11.D |
Hygiene plan |
16.11.2017
GMP Compliance Adviser Update No. 9/2017
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:
| 11.A |
Industrial Hygiene |
| 11.B |
Personnel Hygiene |
13.10.2017
GMP Compliance Adviser Update No. 8/2017
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:
| 14.D |
Laboratory Instruments |
| E.11.1 |
ICH Q11: Q&A
Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) |
15.09.2017
GMP Compliance Adviser Update No. 7/2017
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 Glossary |
updated |
| 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 |
27.07.2017
GMP Compliance Adviser Update No. 6/2017
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:
| 8.A |
Official requirements and agency expectations |
| C.5 |
EU GMP Guide Part II:
Basic Requirements for Active Substances used as Starting Materials
combined with GMP for APIs:
“How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide |
23.06.2017
GMP Compliance Adviser Update No. 5/2017
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
| C.10 |
Compilation of Community Procedures on Inspections and Exchange of Information |
| C.10.1 |
Conduct of Inspections of Pharmaceutical Manufacturers or Importers
|
| C.10.2 |
Outline of a Procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries |
| C.10.3 |
Guideline on Training and Qualifications of GMP Inspectors |
| C.10.4 |
Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials |
| C.10.5 |
The Issue and Update of GMP Certificates |
| C.10.6 |
A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers |
| C.10.7 |
Procedure for dealing with serious GMP non-compliance requiring co-ordinated measures to protect public or animal health |
| C.10.8 |
Procedure for Dealing with Serious GMP Non-Compliance Information Originating from Third Country Authorities or International Organisations |
| C.10.9 |
Guideline on Training and Qualification of Inspectors Performing Inspections of Wholesale Distributors |
| C.10.10 |
GDP Inspection Procedure (Medicinal Products for Human Use) |
| C.10.11 |
The Issue and Update of GDP Certificates (Medicinal Products for Human Use) |
12.05.2017
GMP Compliance Adviser Update No. 4/2017
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:
| 6.J |
Example SOP for the qualification
of equipment and machinery |
| 14.N |
Data integrity in the quality control
laboratory
|
| 15.H |
Data integrity - general requirements
in a GxP-regulated environment |
12.04.2017
GMP Compliance Adviser Update No. 3/2017
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:
| 6.E |
Installation Qualification (IQ) |
| 14.J |
Batch Release
|
| D.1.5 |
21 CFR Part 4 Regulation of Combination Products |
| D.25 |
Guidance for Industry and FDA Staff:
Current Good Manufacturing Practice Requirements for Combination Products |
28.02.2017
GMP Compliance Adviser Update No. 2/2017
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:
| 4.A |
Facility Planning |
| 4.B |
Materials
|
| 13.A.8 |
Packaging material testing |
| D.24 |
Guidance for Industry:
Contract Manufacturing Arrangements for Drugs: Quality Agreements |
| H.18 |
WHO: Good trade and distribution practices for pharmaceutical starting materials
(Technical Report Series, No. 996 (2016), Annex 6) |
01.02.2017
GMP Compliance Adviser Update No. 1/2017
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:
| 6.D |
Design Qualification (DQ) |
| 18.I |
Preparing for FDA GMP inspections
|
| C.21 |
EMA: Data Integrity Questions and Answers |
| E.3.C |
ICH Q3C(R6): Impurities: Guideline for Residual Solvents |
