European GMP Guidelines Pose New Quality Requirements for Drugmakers

The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality.

The new requirement is designed to ensure that testing methods are not altered by a handoff of testing responsibilities from one lab to another within a company or when testing is outsourced to a new vendor.  The new section in Chapter 6 Quality Control of the EU’s good manufacturing practice guidelines says a test transfer written protocol should include:

• Identification of tests to be performed and the relevant methods that are being transferred;

• Acceptance criteria. These should be based on a current validation study of the methodology;

• Identification of any special transport and storage requirements of the test items; and

• Identification of standards and samples to be tested.

Manufacturers should also identify any areas that require test method revalidation, the Commission says.

The chapter was published in April to update the 2006 version of the standard.

The new requirements are part of a comprehensive effort by European regulators to improve quality standards for drugmakers and their suppliers. The Commission has revised other chapters of the GMP guidelines to urge drugmakers to discuss quality requirements with suppliers and create a quality accord.

And last year, the European Medicines Agency released guidance on how drug and active pharmaceutical ingredient manufacturers can determine the threshold for cross-contamination when multiple medical products are in shared facilities

If you’re not sure all of your people are acting on up-to-date quality requirements, then Quality System Training DVD for Drugmakers is for you. Order yours to get a refresher course for your entire staff.