An NSF International Company Revision of EU GMP Guidelines
Thursday the 17th January 2013
Today, the European Commission has launched the public consultation of the following revised GMP guidelines:
Chapter 3: Premises and Equipment
Reasons for changes: The only change is to section 6 as part of the improved guidance on prevention of cross-contamination involving also Chapter 5 and includes reference to a new complementary toxicological assessment guidance.
Chapter 5: Production
Reasons for changes: Changes have been made to sections 17 to 20 to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment guidance. Changes were also introduced in sections 26 to 28 on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Section (33) is inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials while section (68) introduces guidance on notification of restrictions in supply.
Chapter 6: Quality Control
Reasons for changes:
Inclusion of a new section on Technical transfer of testing methods and other items such as out of specification results.
Chapter 8: Complaints, Quality Defects and Product Recalls
Reasons for changes: - To reflect Quality Risk Management principles to be applied when investigating quality defects/complaints and when making decisions in relation to product recalls or other risk-mitigating actions. - To emphasise the need for the cause(s) of quality defects/complaints to be investigated and determined, and that appropriate preventative actions are put in place to guard against a recurrence of the issue. - To clarify expectations and responsibilities in relation to the reporting of quality defects to the Supervisory Authority.
Chapter 3 and 5 should be read in conjunction with the draft EMA guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. This draft guidance suggests that drug manufacturers establish a threshold value for permitted daily exposure (PDE) or threshold value of toxicological concern (TTC) of their product to prevent cross contamination of residual active substances from one product to another in the same manufacturing facility.
Comments and suggestions are invited by 18 July 2025 and should be sent by email to: [email protected] and [email protected]
