Drug Regulators, EME (EMEA), Publish Concept Paper on Revision of the Guideline on Process Validation.

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This concept paper addresses the need to update the guideline on Process Validation. This guideline was originally adopted in February 2001. With the development of new ICH guidelines Q82, Q93 and Q104, this guideline is being reviewed in order to implement the concepts highlighted in the ICH guidelines.

The current guideline does not reflect the recent regulatory developments on Process Analytical Technology (PAT), Quality by Design (QbD) and Real-Time Release Testing (RTRT).

The current guideline was developed before the elaboration of the new ICH guidelines Q8 Pharmaceutical Development, Q9 Risk Management and Q10 Quality Systems. With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation. Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle. In contrast, the current note for guidance on process validation refers only to the more traditional approach of the manufacture of a number of validation batches to confirm that the process is under control. A revision to the note for guidance on process validation will bring it in line with ICH Q8, Q9 and Q10 documents and add the ‘enhanced’ approach to the current ‘traditional’ approach. The annexes of the current guideline will be included in the revised guideline. The revised guideline will also clarify to what extent ICH Q8, Q9 and Q10 should be followed when an applicant wishes to use alternative methods of process validation including continuous verification. The FDA guidance on process validation has been recently revised to take into account ICH Q8, Q9 and Q10. The revision to the note for guidance on process validation will provide a more harmonised approach.

Cick – CMC (Manufacturing) Services – Click

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