Where to Draw the Line?

What is an appropriate level of GMPs for a supplier manufacturing site?

Pharmaceutical and Biotechnology sectors are struggling with the application of GMP and Pharma Style Quality Systems within their excipient, components, and raw material supply chain.

This is, in part, driven by ICH Q9 Quality Risk Management, European Medicines Agency (EMA) Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use, as well as by the Eudralex Volume 4 Annex 16 Certification by a Qualified Person and Batch Release – supply chain requirements.

The simplest solution is application of blanket standards such as EudraLex Volume 4 Good Manufacturing Practice (GMP) guidelines and setting Audit Scopes/Vendor Approval on that basis.

There are two potential outcomes of this approach – the supplier will try to comply with these standards and ultimately pass on the additional cost of doing business, or the supplier will decide the sector is too difficult to deal with and stop supplying. Neither of these outcomes are positive.

Solution – QRM application:

The QRM choice is more difficult than taking a blanket approach to supplier Quality. It requires more up-front resourcing and a more technically interactive approach with suppliers than is traditional.

Internally, it requires an understanding of your processes, how and where the supplied material will be used, and the potential risk to your product from the supplied material. This requires a Cross Functional team and not just the Vendor Management group. The outputs of this should be communicated with the supplier manufacturing site. Externally, it requires an interactive approach with the supplier manufacturing site. One good practice is to invite the supplier manufacturing team to site to give them an insight into how their material will be stored, handled, and used in your processes. It is important to work with the supplier manufacturing site to develop a risk based control strategy for their material. This should include any additional GMP requirements to ensure control.

This QRM driven interactive approach builds a better understanding at the supplier manufacturing site, builds better control strategies, and ultimately delivers higher quality and reduced costs compared to a more traditional supplier qualification program.

Setting the Supplier Qualification Audit Scope:

Can you truly audit a company against a standard to which they do not operate?

The simple answer to this is yes, but your audit outcome is only valid on that day as there is no framework on their site for compliance to that standard. Compliance is therefore a matter of chance.

The key is to include the control strategies at the supplier manufacturing site for managing the risks to your product in your Audit Scope. This control strategy should become an important element in the audit and vendor approval process.