Medicinal products

Public consultation on revision of EU Commission guidelines on Good Manufacturing Practice Medicinal Products, Part I, Chapters 3, 5, 6 and 8

Period of consultation

From 17 January 2013 to 18 July 2013.

Contributions to and results of the consultation

Gedeon Richter Plc. requested that its response not be published.

Below are the public responses to the above-mentioned public consultation:

Objective of the consultation

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.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Additional information: