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Good Manufacturing Practice: the recipe for quality medicine

29 August 2019

When you bake a cake you need to have the right ingredients, and use them in the right order. You can't add an extra egg to the mix after the cake comes out of the oven.

You also need to keep a clean kitchen. Nobody wants to find a fingernail or strand of hair in their sponge cake.

When you're making a cake, quality is something you plan for.

Medicine manufacture is the same, but the stakes are much higher. That's why the quality and safety requirements for manufacturing medicines are higher and regulated more tightly than they are for a home-baked cake.

If you mess up making a cake, it could just taste bad or be a weird shape. If a manufacturer doesn't make a medicine properly, it could make someone sick.

For this reason, in Australia you need a Good Manufacturing Practice (GMP) licence to manufacture a medicine.

What is Good Manufacturing Practice?

GMP is the set of principles and procedures that medicine manufacturers must follow to manufacture a product that meets quality standards. These requirements cover all aspects of manufacture.

The GMP requirements cover things like premises, equipment, personnel, documentation, procedures and systems that control all stages of manufacture… Everything someone needs to plan for and follow when they make a medicine. Australian medicine manufacturers must meet these types of requirements to obtain and maintain a manufacturing license.

For you as a consumer, the benefit is obvious. GMP means you have confidence that the medicine you buy will be what it says it is. GMP ensures that the medicine is of an appropriate quality because it contains the right ingredients, at the right strengths, is sealed correctly and is free of any contaminants.

This is an example of what a GMP-licensed facility looks like:

Licensed manufacture

Under GMP we require that:

  • the environment is suitable for the manufacture of medicines
  • ingredients used for the manufacture of the medicines have been tested, are of acceptable quality and from a known source
  • continual checks are performed and controls are in place to ensure that all stages of manufacture meet manufacturing requirements, that the right materials and equipment are used and that there are no mistakes made in the steps of manufacturing, from start to end
  • the facility and the equipment that are used are clean before use and that the equipment performs as expected.

The list goes on… You can learn more at our Good Manufacturing Practice overview.

What does unlicensed manufacture look like?

Medicines being manufactured in unlicensed facilities is not manufacture under GMP. This is what it can look like:

Unlicensed manufacture

Here are some of the risks of this unlicensed operation:

  • The medicine is being mixed in a bathroom. There is often mould and bacteria in a bathroom, and these could contaminate the medicine.
  • Kitchen bowls, utensils and mugs are being used to make the medicine. If these came from the kitchen, they could be dirty and be a source of contamination.
  • Many of the containers are open. The person making the medicine could breathe, spit or dribble in these containers. Exposure to the air can also change or inactivate some ingredients.
  • The space is disorganised. It would be easy to forget a step in the process, do things out of order or use the wrong materials.
  • There are few labels here. The ingredients could be mixed up, or used in the wrong amounts.
  • You don't know if the ingredients are suitable or what they are composed of.

And that's without even getting started on the toothbrush…

You and your family's health depend on quality medicines. GMP keeps the "kitchen" of medicine manufacture in order.