Consultation Documents
Outcome of Consultation on the proposed update to the Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Part 1: Manufacture of Pharmaceutical Products
Fourteen submitters, including regulatory consultants, pharmaceutical companies, complementary healthcare product companies and industry associations responded to the request for feedback on the March 2009 proposal to update the New Zealand Code of Good Manufacturing Practice, Part 1 to the current PIC/s Guide to Good Manufacturing Practice.
The most common themes in the responses were:
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support for the proposal to adopt the current PIC/s Guide to Good Manufacturing Practice
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requests to extend the proposed implementation period
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predictions of increased costs to comply with the new requirements for product quality reviews, ongoing stability programmes and quality risk assessment
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requests for further guidance on the regulatory expectations for quality risk management
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requests for further guidance on the application of Good Manufacturing Practice to the manufacture of complementary healthcare products for overseas markets.
In response to the consultation Medsafe confirms that:
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as of 1 September 2009 the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Part 1, will be the PIC/s Guide to Good Manufacturing Practice, PE 009-8, parts I, II and annexes 1 to 3, 6 to 15, 17, 19 and 20
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the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Part 1 will be published on the Medsafe website along with a Medsafe introduction to the Code
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individuals will be welcome to download the files at no cost
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when amendments are made to the PIC/s Guide to GMP, each amendment will be reviewed within Medsafe and accepted for inclusion within the NZ Code where relevant.
For new requirements in the Code, product quality review, quality risk management and on-going stability testing, Medsafe:
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confirms that at initial audits subsequent to the implementation of the Code, plans to achieve compliance with requirements that are new to the code will be assessed for acceptability and agreed with Medsafe
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confirms that non-compliances against the new requirements will be raised but not treated as deficiencies prior to 1 September 2010
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will consider appropriate methods to provide further guidance to stakeholders on expectations for the new requirements in the Code
For GMP audits performed at a company's request Medsafe will discuss with the company the appropriate code of GMP to be used and any relevant guidance documents that should be followed.
Proposed update to the New Zealand Code of Good Manufacturing Practice - Consultation closed