September 24, 2020
You may be considering building a new facility for growing, harvesting, and processing medical cannabis, or perhaps you have an existing facility and want to export to the European Union. What should you do to be inspection ready? You may be aware of the transition from Good Agricultural Practice (GAP) to Good Manufacturing Practice (GMP), or “when the scissors are put in”. But what is next? Here are six points to consider.
The first consideration is that quality and GMP are (or should become) part of your company DNA: there is no substitute for living and breathing GMP. This requires people who understand the importance of GMP and never take their eye off it. GMP is instrumental in training, coaching, and living by example. Some people may consider GMP as excessive or too expensive, especially when they have a background outside of pharma. In the end, however, employees at every level play a role in achieving and maintaining GMP compliance, and the importance of that should not be neglected. It is as simple as that.
All processes are closely linked to the third consideration: all critical processes need be documented in procedures. While executing, all steps, actions, notes, and deviations need be written down in batch records, analytical data sheets, logbooks, etc. If it is not documented, it has not been done. Eudralex Vol. 4 presents a nice overview of these expectations, and includes nine chapters:
Secondly, you need measurable processes. The obvious ones are manufacturing, testing, storage, and dispatch. Less obvious, but equally important, is a release process by an independent Qualified Person (QP). This is a specific requirement of EU regulation (Eudralex Vol. 4), which implies that even a CEO cannot overrule a decision not to release batches. The starting point is that you need a process, taking into account all aspects of release, such as starting materials, intermediates, test results, and final product.
Other important processes are change and deviation control. From an inspectors’ perspective it is an easy target. For example, if a company has only five changes in a year, this is too good to be true and raises a red flag to inspectors. Each change and deviation must go through a formalized process of writing, review, and implementation. You need documentation, not a “just do it” attitude.
These two processes are the hardest to maintain, as my personal conclusion from many audits in the field. On the positive side, they are proof of a state of control.
A pharmaceutical company requires committed roles, all of which are described in an internal Quality Management System (QMS). The QMS provides clarity by defining roles, responsibilities, and processes, thereby ensuring that your product is manufactured, imported, released, and distributed in a compliant manner. If additional companies are involved in the supply chain, its setup is crucial for launch readiness and interactions among the various parties throughout the supply chain.
There are several service providers that you may need to involve in your business. The roles and responsibilities of the various service providers must be agreed upon and described in the QMS. Between the various service providers, Quality Agreements should be put in place to clearly define their interactions. Once completed, the QMS needs to be communicated to the authorities, and a manufacturing license should be applied for.
In addition to a Quality Management System, you should also consider qualification and validation. This is a specific requirement, seen in GMP regulations around world, including the EU, USA, and Japan. It applies to all facilities, equipment, software, processes, cleaning, and analytical methods. All? Well, yes, if it is under a GMP regime (“after the scissors”).
Writing down your requirements and testing these, while using formalized protocols and reports is crucial. For example, you may have developed a nice drying process, but you need to demonstrate that it is working properly. On an equipment level, you need to show that the dryer is installed according to specifications and that it is functioning as it’s supposed to. And, not to forget, show that your product is dried and meets specifications. Within qualification and validation, it is important to do everything that is needed, yet in a pragmatic manner. The umbrella covering all this is the Validation Master Plan, which is a specific EU requirement.
Finally, I am truly convinced that quality should be an internal driver for everybody, in any company. I also realize that a key step in accessing the EU market is successfully passing an inspection. You need to trigger this by submitting the right documentation. And when the actual inspection is announced you need to thoroughly prepare. It is obvious that all elements described above need to be in place and functioning properly. But also make sure that everybody understands the appropriate procedures for an inspection, including cultural aspects you may encounter.
Running a smooth front and back office, enabling you to respond quickly to any request from the inspectors also helps. And after the inspection, respond quickly to any follow-up action. With all this together, you may receive your manufacturing license in the end. If you need support setting up any of these processes, contact the experts at ProPharma Group.
TAGS: Life Science Consulting
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