Industry calls for global alignment of qualification and validation guidelines

By Dan Stanton

- Last updated on GMT

The European Commission (EC) in Brussels, Belgium
The European Commission (EC) in Brussels, Belgium

Related tags European union

EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.

In February 2014​, the European Commission published draft GMP guidance recommending European drugmakers control the critical aspects of their operations through qualification and validation across the lifecycle of the product and process.

Since then, the EC has issued a revision​ to take into account principles set out in ICH Q8, Q9, Q10​ and Q11​, and other guidance on process validation, and changes in manufacturing technology, and invited stakeholders to comment.

Industry’s response were made public last week, and the European Industrial Pharmacists Group (EIPG) heralded the guidance as “a true evolution which effectively integrates both risk analysis and mechanistic approaches to quality, in connection with QbD.”

The European Generic medicines Association (EGA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) also welcomed the revisions outlined in the EU GMP guidance, which both said helped reflect changes that have occurred in the manufacturing and regulatory environment and the current use of Quality Risk Management .

But both groups told the EC that more needs to be done to ensure the process validation and qualification requirements are aligned across global regulatory bodies.

“Companies operate manufacturing environments supplying different regions and divergences between jurisdictions create an unnecessarily complex environment for manufacturing operations and compliance,”​ the EGA said.

EFPIA added that “there should be alignment as far as possible with other existing key international process validation guidelines, which are binding for industry,”​ to help avoid over-complexity which may drive divergence and misinterpretation by both industry and regulators.

“In particular it is apparent that there is still confusion in industry about the differences between ‘continuous process verification’ from ICH Q8 and ‘continued or on-going process verification’, especially where translation of these concepts from English must be considered.”

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