Industry news

European Commission issues three draft documents for comment

1. Guideline on GDP for APIs for Human use.

At just 7 pages this draft is, mercifully, much shorter than the 30 page draft EU GDP for finished products that was issued in July 2011 (and which has still not been finalised.

2. Guideline on the formal Risk Assessment to determine the appropriate GMP for Excipients (as required by the Falsified Medicines Directive, 2011/62/EU)

This draft guidance consists of three main sections:

• Section 2: “Determination of appropriate GMP based on type of excipient” provides guidance on how to assess and rank the risk presented by the excipient

• Section 3: “Determination of Excipient Manufacturer´s Risk Profile” covers identification of appropriate GMP and assessment, ranking and control of the risk profile of the excipient manufacturer

• Section 4: “Confirmation of Application of Appropriate GMP” presents guidance on how to manage the risks of use of the excipient on an on-going basis.

3. Template for QP’s Declaration of GMP Compliance for IMPs manufactured in non-EU countries.

This is a simple two page template. The declaration can be made on the basis of either a personal audit by the QP or an audit conducted by a third party (which includes audits by other QPs employed by the same company). If the manufacturing site has not been audited a justification as to how the QP knows that the site meets EU GMP has to be provided.

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