The TGA’s code of GMP recommends that all suppliers be qualified – “The process of assessing the reliability of a supplier to consistently provide material of acceptable quality”.
For complementary manufacturers with many, many suppliers, qualifying them all is an onerous and expensive exercise.
For raw materials, intermediate and final products that are from un-qualified suppliers, the TGA’s GMP code has requirements for sampling and testing to ensure product quality. Manufacturers of complementary medicines, have struggled to meet these requirements. They often have large numbers of different raw materials, their raw materials, e.g. herbs and roots, are difficult to test and the industry wants to minimise the costs associated with the required testing regime.
Bulk product characteristics are routinely tested to determine whether the product meets in-house quality assurance specifications.
Raw or processed materials are frequently stored in drums or containers. In these instances, it’s common to choose a representative sample that exhibits characteristics similar to those processed by the population as a whole.
When determining your sampling method, it is important to understand the supplying manufacturer’s process, ie. how they make up a batch:
- Is it a raw or processed material?
- Is it of natural origin; therefore often subject to huge variation or is it a liquid raw material manufactured in a large bulk tank with vigorous and validated mixing?
If so, qualifying your supplier can reduce your testing, or as in the case of a natural product, frequently subject to high variation, increase the testing due to the increased risk of having poor active content.
Commerically, it is better to discover that a raw material does not meet quality standards before adding other ingredients, labour and processing costs. Once the substandard raw material has been consumed by your production process, there is no raw material left if you need to prove to your supplier that it did not meet specifications.
The GMP’s are really just common sense guidelines that have been developed by years of other people’s mistakes. Following these rules can save costly and embrassing errors.
What are the requirements?
After much consultation with the industry about a number of issues, the TGA released guidelines (refer to the TGA website for the latest requirements) for the sampling and testing of complementary medicines. To summarise the requirements:
- Excipients – you can use the square root of n + 1 sampling method
- Actives – All containers are to be sampled
- Intermediate product – All containers are to be sampled (except solid dosage forms transported for coating) and product must be sourced from a manufacturer with a TGA licence or TGA GMP clearance
- Bulk product – product must be sourced from a manufacturer with a TGA licence or TGA GMP clearance. Sampling requirements depend on integrity sealing, refer to theTGA website for the latest technical guidance document
- Finished product – refer to the TGA website for the latest technical guidance document
Reducing the workload
The requirement to sample and identity test EVERY container of active ingredient in a raw materials warehouse has many complementary medicine manufacturers reeling. It creates a huge load on the QC lab, potentially creating a production bottleneck.
Whilst your ultimate aim should be to qualify your suppliers (the TGA has a supplier qualification guidance document for complementary medicine manufacturers refer the TGA website), ensuring product quality along the supply chain, PharmOut recommends the following approaches to reduce the load for materials from unqualified suppliers.:
- Use of a portable FTIR or ITMS to do insitu identity tests in the warehouse (remember – it’s only the identity testing that is required for every container).
- Ordering larger container sizes of raw materials to reduce the number of containers
- Sorting incoming raw materials into supplier batches and documenting a justification to reduce the testing requirements based on the fact that each batch should be homogeneous.
Taking one or more of these steps will reduce the number of samples reaching the QC lab whilst still meeting the TGA’s requirements.
Note: PharmOut routinely qualifies vendors for companies. Our shared audit service allows you to share the cost of auditing an overseas supplier with our other clients.