Good manufacturing practice: an overview

Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.

A basic tenet of GMP is that:

• quality cannot be tested into a batch of product
• quality must be built into each batch of product during all stages of the manufacturing process.

There are different codes of GMP, depending on the type of therapeutic good:

• Good Manufacturing Practice for Medicines
• Good Manufacturing Practice for Human Blood and Tissues

A different system, known as conformity assessment, is used to ensure that medical devices are of high quality.

Inspections

Australian based manufacturers of medicines and biologicals are required to hold a licence to manufacture.

To obtain a licence, a manufacturer must demonstrate compliance with the relevant code of GMP. This is usually, but not always, done through an on-site inspection.

Overseas manufacturers of medicines supplied to Australia are also required to meet an acceptable standard of GMP.

If acceptable documentary GMP evidence cannot be provided, the TGA will undertake on-site inspections in the same manner as those conducted for the Australian manufacturers.

It is an offence in Australia to manufacture therapeutic goods for human use without a licence or certification unless the manufacturer is exempt from this requirement under the Therapeutic Goods Act 1989.