GMP News No. 676
22 February 2006
|Current Packaging Materials Requirements|
A frequently asked question with regards to packaging materials in the pharmaceutical industry and its suppliers is: What are the requirements?
Following you'll find some important information sources:
Specification requirements for packaging materials and materials for the manufacture of packaging materials are comprised in the European and the American Pharmacopoeias (www.pheur.org) and (www.usp.org).
Requirements relative to pharmaceutical plastic packaging materials in Europe are included in the EMEA Guideline on Plastic Primary Packaging Materials. This guideline became effective 01 December 2005.
Comparable for the US is the document FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics, covering the comprehensive requirements for developing and routine testing of packaging materials.
The sampling plan for packaging materials should take account of at least the following: the quantity received, the quality required, the nature of the material, the production methods and what is known of the Quality Assurance system of the packaging materials manufacturers based on audits. The number of samples should be determined statistically and specified in a sampling plan.
Due to the new Annex 19, covering reference samples and titled "Reference and Retention Samples, there are new requirements relative to reference samples in Europe, which are also specifically valid for packaging materials. This new Annex 19 will become effective 01 June 2006.
Comparable FDA requirements for testing and handling packaging materials in the manufacture of medicinal products in the US are covered in 21 CFR Part 211, and controlling drug product containers and closures specifically in section 21 CFR 211.80 211.94.
GMP requirements for packaging materials manufacturers were published by the German Institute for Quality Assurance and Certifications e.V. in 2004 basically transferring the requirements in the EU GMP guide for pharmaceuticals manufacturers to packaging materials manufacturers.
New is a draft for the norm DIN ISO 15378, edition 2004-07, titled "Primary Packaging Materials for Medicinal Products Particular Requirements for the Application of ISO 9001:2000 with Reference to Good Manufacturing Practise (GMP)". The norm is supposed to be used for certifying packaging materials manufacturers, and will possibly constitute the common standard relative to GMP requirements for packaging materials manufacturers in the future.