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Based on a German initiative, an international standard on quality management systems for the primary packaging materials of medicinal products is discussed in this article. This new directive will help to standardize the production of primary packaging materials by defining global requirements.
The international standard "Quality management systems - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)" is a German initiative that will help the standardization of manufacturing primary packaging materials. A draft of the standard (ISO/CD 15378) has been circulated worldwide for comments by experts.
The initial work was done by the Deutsches Institut fÃ½mung (DIN) and Normenausschuss Medizin (NAMed), who then submitted the standard to a working group of the International Organization for Standardization (ISO). Draft 15378 is based on ISO/TC 176/SC 2, which is responsible for the development of the ISO 9001 and ISO 9004 international standards as well as other international standards and documents in the ISO 9000 family.
Draft 15378 provides a major contribution to developing relations between the pharmaceutical industry and manufacturers of primary packaging materials. The packaging manufacturers are certified according to ISO 9000:2000 and the pharmaceutical industry expects its suppliers to meet GMP requirements. This is a great challenge to the manufacturers, who are being increasingly audited and certified in purely GMP-oriented audits by pharmaceutical customers, based on rules applicable to the pharmaceutical industry and individual requirements. However, regarding the "strictness" of requirements to GMP, differences between the pharmaceutical industry and manufacturers of primary packaging materials must be duly taken into account; that is, GMP requirements must be suitably "adapted" to the manufacture of primary packaging materials.
Draft 15378 provides both the pharmaceutical industry and suppliers with a set of rules enabling them to manufacture products according to defined GMP requirements and to implement quality control and quality assurance measures. An important aim of the draft is for manufacturers of primary packaging materials for medicinal products to obtain an officially recognized GMP certification based on ISO 9001:2000. The draft will create a link between ISO and GMP, ensure that there are common terms and definitions within the pharmaceutical industry and enhance GMP understanding. Additionally, the draft defines the global requirements that packaging manufacturers must meet with regards to the pharmaceutical industry and covers packaging made of glass, rubber, plastic, aluminium, foils and laminates. The new standard is of particular significance because many of these materials are used in the manufacture of parenterals.
At an ISO meeting last January (2003), a project team was formed to develop industry-specific standardization and information requirements for the various groups of packaging materials. Comments regarding a second draft of 15378 were discussed with international experts of technical committee (TC) 76, and in due course the secretariat of ISO/TC 76 will provide a revised draft. BPI and VFA expressly support this project and request the participation of both the pharmaceutical industry and of the manufacturers of primary packaging materials (