Hanoi-Vietnam: Additions to the roadmap for pharmaceutical packaging production

Circular 02 stipulates that from March 1, 2016, manufacturers of drugs being sold in the market  in Vietnam must use primary packaging, which are provided by packaging producers fulfilling GMP requirements for pharmaceutical packaging or possessing one of these certificates:

- Certificates of conformity of pharmaceutical packaging producer to GMP, as issued by competent health or pharmaceutical authorities.

- Certificates of eligibility for production of pharmaceutical packaging, as issued by competent health and pharmaceutical authorities in relevant countries, papers granted by pharmaceutical authorities in nations that participate in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH), European Union (EU), Pharmaceutical Inspection Co-operation Scheme (PIC/S) for endorsement of manufacturing of packaging for pharmaceutical products and foodstuffs, Drug Master File (DMF) recognized by U.S. Food and Drug Administration (USFDA) with the link to the information post on the website of USFDA.

- ISO 15378 certificate (Primary packaging materials for medicinal products - Particular requirements for application of ISO 9001:2008 with reference to Good Manufacturing Practices (GMP)) as issued by a certifying body that has been assessed and recognized by an international accreditation organization according to international standards.

- ISO 13485 certificate (Medical Devices - Quality management systems - Requirements for regulatory purposes) for packaging of drug containment tools (cartridge and syringe) as issued by a certifying body that has been assessed and recognized by an international accreditation organization according to international standards.

- ISO 9001 certificate (Quality management systems - Requirements) for materials of pharmaceutical packaging shaped right in the process of drug manufacturing.

International accreditation organizations as stated in above include: Bureau Veritas, TÜV (Technischer Überwachungs Verein), SQS (Swiss Association for Quality and Management Systems), SGS (Société Générale de Surveillance), IQnet (The International Certification Network), BSI (The British Standards Institution), DQS (German Registration for Management Systems), GTÜ (Gesellschaft für Technische Überwachung), International Certification Management GmbH.

Details may be found in Circular 02/2016/TT-BYT effective from January 12, 2016.

-Thao Uyen-

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