On 29 July 2009, the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2009 adopted the Guide to Good Manufacturing Practice - 15 January 2009 as issued by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) to become the new Code of Good Manufacturing Practice for Medicinal Products (New GMP). The New GMP became mandatory from 1 July 2010.
The New GMP replaces the previous Australian Code of Good Manufacturing Practice for Medicinal Products (2002) and the Australian Code of Good Manufacturing Practice for sunscreen products (1994). There are currently 35 national authorities participating in PIC/S. The New GMP is aligned with the PIC/S guide and harmonises procedures and technical standards with international inspection standards for the production and testing of medicinal products, which will allow the TGA to establish mutual recognition agreements with overseas authorities and help reduce regulatory compliance burdens.
The most significant changes for manufacturers of medicinal products are:
- the requirement to prepare annual Product Quality Reviews
- the requirement to use quality risk management
- detailed procedures on stability testing
- detailed procedures on reference and retention samples, And
- several changes for the manufacture of sterile medicinal products are also included in Annex 1.
The New GMP consists of two parts:
- Part I - manufacture of finished medicinal products
- Part II - manufacture of Active Pharmaceutical Ingredients (APIs)
The provisions of the New GMP are outlined in annexures as follows:
- Annex 1: Manufacture of sterile medicinal products (significant additions regarding Steriles)
- Annex 2: Manufacture of biological medicinal products for human use
- Annex 3: Manufacture of radiopharmaceuticals
- Annex 6: Manufacture of medicinal gases
- Annex 7: Manufacture of herbal medicinal products
- Annex 8: Sampling of starting and packaging materials
- Annex 9: Manufacture of liquids, creams and ointments
- Annex 10: Manufacture of pressurised metered dose aerosol preparations for inhalation
- Annex 11: Computerised systems
- Annex 12: Use of ionising radiation in the manufacture of medicinal products
- Annex 13: Manufacture of investigational medicinal products
- Annex 15: Qualification and validation
- Annex 17: Parametric release
- Annex 19: Reference and retention samples (new annexure)
- Annex 20: Quality risk management (new annexure) 14 | Health Law Bulletin - DLA Phillips Fox
The TGA is currently reviewing its guides for the manufacture of complementary medicines and medicinal gases, and will be available shortly.
Manufacturers of medicinal products are advised to review their current procedures, quality and risk management systems to consider whether any changes are required to comply with the New GMP.
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