Regulatory Focus™ > News Articles > EC Releases New Good Manufacturing Practices Guidelines

EC Releases New Good Manufacturing Practices Guidelines

Posted 17 January 2013 | By Alexander Gaffney, RAC

The European Commission (EC) has launched a public consultation on four revised chapters of its good manufacturing practice guidelines, saying a number of changes were necessary to reflect best practices and the latest thinking.

One of the sections set to be revised is GMP Chapter 3, which details ways in which companies should reduce the potential for cross-contamination in facilities that manufacture multiple product lines. Factories should be designed properly to ensure that cross-contamination does not occur, and owners are advised to follow Quality Risk Management principles to assess and controls risks present or inherent in the facility.

"Risk assessment should include among other parameters a toxicological evaluation of the products being manufactured," the chapter notes.

Some facilities, however, will not be permitted to manufacture multiple product lines. Those include cases when cross-contamination cannot be adequately controlled by operational or technical measures, when or if scientific data does not support threshold values, or if threshold values are too difficult to detect.

Chapter 5 expands upon this logic, and EC notes the two should be read in conjunction with a draft European Medicines Agency (EMA) guideline on exposure limits in manufacturing facilities. The chapter contains several new revisions, including refined guidance on where products should and should not be manufactured (i.e. not in the presence of non-medical products) and the use of technical poisons like pesticides or herbicides (don't use them in the presence of medical products).

Sections 26, 27 and 28 of the chapter also explain that suppliers and starting materials will need to be qualified so as to ensure that products are traceable within the supply chain. This will require documentation and supervision to guard against adulteration.

"The supporting evidence for each supplier/material approval should be maintained," EC explained. "Staff involved in these activities should have a current knowledge of the suppliers, the supply chain and the associated risks involved. Where possible, starting materials should be purchased directly from the manufacturer of the starting material."

This logic applies not just to active pharmaceutical ingredients (APIs), but also to excipients which could "pose a particular risk to the quality of the medicinal product," the chapter explains. All starting materials used in the production of medicines should be tested, as should the finished product.

Chapter 6 includes a new section on technical transfer of testing methods as well, which explains that test methods should be verified so that they are the same as those validated in the original marketing authorization dossier. The transfer of this technology between testing facilities needs to be documented and tested to ensure that the technology is the same, operators are adequately trained, standards are maintained and acceptance criteria is established.

Finally, GMP Chapter 8 has undergone revisions to reflect new Quality Risk Management principles for the investigation of defects, complaints and responsibilities. The Chapter is extensive, and includes everything from detailing the receipt of the complaint, its investigation, its analysis, determining its causes, determining how to prevent such defects in the future, and an assessment of recall actions.

All chapters will go into effect on 17 June 2013.


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