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Focus: New Code of Good Manufacturing Practice for therapeutic goods

22 June 2010

In brief: The Code of Good Manufacturing Practice applicable to all manufacturers of medicines, including manufacturers of active pharmaceutical ingredients, will be updated from 1 July 2010. Senior Associate Ric Morgan and Law Graduate Saul Lazar look at what this entails.

How does it affect you?

  • From 1 July 2010, manufacturers of medicinal products will be required to conduct: annual product quality reviews; a quality risk management process; and an ongoing stability program in relation to their products.
  • Additionally, manufacturers of sterile medicines will be subject to specific new manufacturing requirements.

Background

With effect from 1 July 2010, the Australian Code of Good Manufacturing Practice for Medicinal Products – 16 August 2002 will cease to apply to manufacturers of medicinal products1 and, in its place, the PIC/S Guide to Good Manufacturing Practice – 15 January 2009, PE 009-8 (2009 GMP Guide)2 will become the new Code of Good Manufacturing Practice applicable to all manufacturers of medicines.

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Annual product quality reviews

The 2009 GMP Guide introduces a requirement for manufacturers to prepare annual product quality reviews (APQRs) for each of the manufacturer's medicines. APQRs are to be conducted with the objective of verifying the consistency of existing processes and the appropriateness of current specifications for both starting materials and finished products.

At a minimum, APQRs must review:

  • starting materials and packaging materials used for products;
  • critical in-process controls and finished product results;
  • all batches that failed to meet established specifications;
  • all significant deviations or non-conformances, associated investigations and the effectiveness of resultant corrective and preventative actions;
  • all changes carried out to the processes or analytical methods;
  • all marketing authorisation variations submitted, granted or refused;
  • results of stability monitoring programs (see below) and any adverse trends;
  • adequacy of any other previous product process or equipment corrective actions;
  • post-marketing commitments, for new marketing authorisations and variations to existing authorisations;
  • the status of relevant equipment and utilities; and
  • technical agreements to ensure currency.

Where the sponsor on the Australian Register of Therapeutic Goods for a product uses a contract manufacturer, there must be an agreement in place that defines the respective responsibilities for producing the APQR.

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Quality risk management

The 2009 GMP Guide introduces quality risk management as an element of good manufacturing practice. Manufacturers will be required to have systematic processes for the assessment, control, communication and review of risks to the quality of the product.

In conducting quality risk management, manufacturers must ensure that risk evaluations are based on sound scientific knowledge and experience of the manufacturing process. The level of detail for a given product must be proportionate to the level of risk presented by that product.

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On-going stability programs

Manufacturers will be subjected to additional stability monitoring of after-market products. Stability monitoring is to be undertaken in relation to at least one batch of each product manufactured each year in every strength and primary packaging type, and to continue for the shelf-life of each product.

At a minimum, the program must include:

  • relevant physical, chemical, microbiological and biological test methods;
  • acceptance criteria;
  • reference to test methods;
  • description of the container closure system;
  • testing intervals;
  • description of the conditions of storage (standardised ICH conditions for long-term testing to be used); and
  • any other applicable parameters specific to the particular product.

These requirements will extend to bulk products and intermediates that are stored or used over prolonged periods.

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Sterile medicinal products

Annex 1 to the 2009 GMP Guide makes several changes in relation to the manufacture of sterile medicines as follows:

  • An increase in the permitted number of particles in clean rooms, in accordance with EN ISO 14644-1.
  • Stricter requirements for the monitoring of clean rooms, based on a formal risk assessment.
  • A requirement to provide clean sterile protective clothing.
  • A requirement for bio-burden monitoring in relation to each batch.
  • Increased requirements for partially stoppered freeze drying vials relating to capping and crimping.

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Follow up

For further information, the Therapeutic Goods Administration has produced two documents – Questions & Answers on the Code of Good Manufacturing Practice, Version 8.1, 29 April 2010, Therapeutic Goods Administration, and the Adoption of the January 2009 PIC/S GMP Guide For Medicines as a Manufacturing Principle: Summary of New or Amended GMP Requirements, Therapeutic Goods Administration – that may help. If you have any queries about these changes please call one of the contacts listed below.

Footnotes
  1. The Therapeutic Goods (Manufacturing Principles) Determination No 1 2009 (Cth) will revoke the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2002 (Cth), effective 1 July 2010.
  2. Therapeutic Goods (Manufacturing Principles) Determination No 1 2009 (Cth).

For further information, please contact:

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