Updated manufacturing principles for medicinal products
31 July 2009
On 29 July 2009 the TGA National Manager determined new principles to be observed for manufacturers of medicinal products (including active pharmaceutical ingredients and sunscreen products) under Section 36(1) of the Therapeutic Goods Act 1989.
Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2009 brings Australian manufacturing requirements into line with current international practices by adopting the PIC/S Guide for Good Manufacturing Practice for Medicinal Products - 15 January 2009 <http://www.tga.gov.au/manuf/picsgmpmed.htm> issued by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) in January 2009. The PIC/S Guide also incorporates the ICH Harmonised Tripartite Guideline Good Manufacturing Practice for Active Pharmaceutical Ingredients.
The TGA's adoption of harmonised international standards helps to minimise the regulatory burden on Australian companies seeking to compete in the global economy and preserves Australia's equivalence with its regulatory partners under the provisions of several Mutual Recognition Agreements for GMP inspections and certifications.
The most significant changes in this update to the Manufacturing Principles relate to product quality reviews and sterility requirements in Annex 1. Product quality reviews will involve periodic assessment of past reviews, in-process controls, failed batches, deviations and non-conformities, process or equipment changes, marketing authorisation variations, stability results, complaints and recalls, and technical agreements to identify improvements. Annex 1 relating to the manufacture of sterile medicinal products reflects changes to particle count limits, airflow monitoring in Grade A processing areas, protective clothing requirements, limits to aseptic process media fills and capping and crimping aseptically filled vials.
The PIC/S Guide also includes explicit requirements for monitoring product stability over the shelf life of a product and permits the voluntary use of risk management tools to demonstrate compliance with the Guide.
The 2009 PIC/S Guide is available at: PIC/S Guide for Good Manufacturing Practice for Medicinal Products - 15 January 2009 <http://www.tga.gov.au/manuf/picsgmpmed.htm>.
The TGA intends that the Manufacturing Principles will be updated over time in line with changes to the PIC/S Guide.
Transition
The Determination provides for a transitional period for manufacturers to make any changes to their manufacturing procedures that may be needed to comply with the updated Good Manufacturing Practice (GMP) requirements, which will become mandatory on 1 July 2010. Manufacturers may also elect to have the updated Manufacturing Principles apply earlier.
After 1 July 2010, references to medicinal and sunscreen products will be removed from Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2007 and Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2002 relating to Active Pharmaceutical Ingredients will be withdrawn.
The Office of Manufacturing Quality is arranging briefings for industry in the next few months, with further seminars to be held to examine more detailed aspects of the PIC/S Guide.
Links
Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2009
<http://www.tga.gov.au/legis/mp0901.htm>
- PIC/S Guide for Good Manufacturing Practice for Medicinal Products - 15 January 2009
<http://www.tga.gov.au/manuf/picsgmpmed.htm>
Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2007
<http://www.tga.gov.au/legis/mp0701.htm>
- Australian Code of Good Manufacturing Practice for Medicinal Products 2002
<http://www.tga.gov.au/docs/html/gmpcodau.htm> - Australian Code of Good Manufacturing Practice - Human Blood and Tissues 2000
<http://www.tga.gov.au/manuf/gmpbltic.htm> - Australian Code of GMP for Therapeutic Goods Sunscreen Products 1994
<http://www.tga.gov.au/docs/html/gmpsunsc.htm>
Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2002
<http://www.tga.gov.au/legis/mp0201.htm>
- ICH Harmonised Tripartite Guideline - Good Manufacturing Practice for Active Pharmaceutical Ingredients 2000
<http://www.tga.gov.au/legis/mp0201.htm>