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)
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 GMP compliant use of packaging materials in the pharmaceutical
industry is covered in detail in the EU GMP Guide, Part I under item
5.40 to 5.43. Specifically Annex 8, item 5, refers to sampling of raw
and 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.
- In addition, the Publishing House Editio Cantor issues Defect
Evaluation Lists, playing an important role in practice (www.ecv.de).
These lists contain specific suggestions for testing various packaging
material types (samples plans and AQL values, etc).