9/10 March 2021
Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the materials are released only after their quality was judged as satisfactory.
But how to reduce testing and comply with GMP?
According to the revised draft chapter 5 – Production – of the EU GMP Guide from January 2013, the selection, qualification, approval and maintenance of suppliers has to be documented and the level of control has to be proportionate to the potential risks posed by the individual materials. Manufacturers of medicinal products are responsible for testing the starting and packaging materials as described in the marketing authorisation dossier. However, it is explicitly accepted to utilise partial or full test analysis results for a material from an approved manufacturer, if the following requirements are fulfilled:
a) A formal agreement including the transport conditions to ensure the maintenance of the quality characteristics of the starting materials
b) Regularly performed audits at the production sites
c) A certificate of analysis signed by a designated person with appropriate qualifications and experience
d) Significant experience in dealing with the starting material manufacturer (“history of compliance”)
e) Full analyses that are performed regularly by the medicinal product manufacturer to compare the results with the supplier’s certificate of analysis.
The deadline for comments to the revised EU GMP Guide Chapter 5 was 18 July 2013. The deadline for coming into operation will be 6 months after the publication of the final chapter 6.