Monday, 15 June 2015

EU GMP updates 2015


Changes to EU GMP this year include:

Chapter 3: 'Equipment and Facilities' - updated guidance on preventing contamination including using Quality Risk Management principles to assess and control the risks. Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products.

Chapter 5: 'Production' - improved guidance on prevention of cross-contamination (cross referencing with Chapter 3). Changes also introduced a new section 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 and supply chain traceability. Sections were inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials.

Chapter 7: 'Complaints, Quality Defects and Product Recalls' - extensive changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. It emphasises the need for the cause(s) of quality defects or complaints to be investigated and determined, and that appropriate preventative actions are put in place to guard against a recurrence of the issue and clarifies expectations and responsibilities in relation to the reporting of quality defects to the authorities.

In addition to the main chapters:

Annexe 15: Qualification and Validation' - new version to be implemented in October 2015.

Annexe 16: 'Certification by a Qualified Person and Batch Release' - new version in preparation.

Posted by Tim Sandle

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