Revision of EU Commission guidelines on Good manufacturing Practice Medicinal Products
On Jan 17, the European Commission launches the public consultation of the following revised guidelines on good manufacturing practices:
Chapter 3: Premises and Equipment
(53 KB)
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.
(53 KB) 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(84 KB)
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.
(84 KB) 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(63 KB)
Reasons for changes:
Inclusion of a new section on Technical transfer of testing methods and other items such as out of specification results.
(63 KB) 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(79 KB)
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.
(79 KB) 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 
(170 KB)on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Comments and suggestions are invited by 18 July 2013 and should be sent by email to: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu
(170 KB)on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilitiesComments and suggestions are invited by 18 July 2013 and should be sent by email to: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu
