Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
Reference market
Producers and packagers of primary packaging for the pharmaceutical and medical sector in:
- cellulose;
- polyethylene;
- glass;
- other.
Reasons and benefits
Ensure safety of primary packaging related to the pharmaceutical and medical sector against risk of microbiological, chemical and particle contamination and ensure the desired functionality.
Greater guarantee for the client pharmaceutical or medical company with consequent reduction of second party audits.
Main aspects
General requirements of Quality Management Systems;
Specific enclosures:
- good manufacturing practice;
- guide for the verification and validation of materials produced (when this is a requirement);
- guide for performing the risk analysis related to the production of packaging material for medicines (based on ISO 14971).
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