Another episode in our series of acronym certification. This time a COA (otherwise known as CoA)
So, you have followed the rules required by GACP and GMP. You went out of your way to create an SOP. Now it’s time for the final hurdle to the finish line, the COA or Certificate of Analysis, also known as a test report.
(Please note that this information on COA’s applies to EU rules and standards. COA’s differ from country to country, so please check with your friendly local bureaucrat)
We can hear you sigh, we really can. But hey, to be in this business you must stick to the rules of this business. Like our fairy tale princess, you must kiss the frogs before you get to the prince – metaphorically speaking of course. So, here we go with telling you what a COA is, why it’s needed and how to do. Unlike the story of the princess and the frog, it’s not a fairy tale and one to be taken seriously.
In business credibility is everything and a credible business is a successful business. Part of achieving this credibility is having a Certificate of Analysis.
What is it?
Certificates of Analysis provide a summary of testing results on samples of products or materials together with the evaluation for compliance to a stated specification. It normally describes the results obtained for the tests prescribed in a pharmacopeial monograph.
A COA is a document that communicates the results of a test done on a product either as food or drugs.
A Certificate of Analysis is a document that certifies that the product that you are supplying adheres to the standards that you promised or that is expected from the client. If done correctly, it prevents returns and lawsuits and guarantees a happy customer. It serves as a quicker way to move product around and identify it easier. A COA is usually required whenever a customer needs to report to a regulatory agency or a government body.
Why is it a good thing to have it?
A COA is a document that proves the tests that have been performed on a given product. You have to prepare the technical documentation. Most countries require a COA for importing and exporting food products, while for other products such as pharmaceuticals and chemical products, a stricter analysis process is needed.
What is the format?
According to the EU-GMP Part II, the Certificates of Analysis should obey the following principles
- Authentic Certificates of Analysis should be issued for each batch of intermediate or API on request.
- Information on the name of the intermediate or API including where appropriate its grade, the batch number, and the date of release should be provided on the Certificate of Analysis. For intermediates or APIs with an expiry date, the expiry date should be provided on the label and Certificate of Analysis. For intermediates or APIs with a retest date, the retest date should be indicated on the label and/or Certificate of Analysis.
- The Certificate should list each test performed in accordance with compendial or customer requirements, including the acceptance limits, and the numerical results obtained (if test results are numerical).
- Certificates should be dated and signed by authorised personnel of the quality unit(s) and should show the name, address and telephone number of the original manufacturer. Where the analysis has been carried out by a repacker or reprocessor, the Certificate of Analysis should show the name, address and telephone number of the repacker/ reprocessor and a reference to the name of the original manufacturer.
- If new certificates are issued by or on behalf of repackers/reprocessors, agents or brokers, these certificates should show the name, address and telephone number of the laboratory that performed the analysis. They should also contain a reference to the name and address of the original manufacturer and to the original batch certificate, a copy of which should be attached.
How do I do it?
Do not think that the process is too costly or time consuming. It is increasingly becoming a standard business procedure rather than just a recommendation. A COA is usually quality control personnel who will make sure that they are fulfilling the prescribed standards set.
These test and certifications can be electronic or paper if your product will end up in the EU. It is also important to understand that these rules differ from country to country and that your COA needs to comply with the rules set by the country where your product will go to, not where it comes from. You’ll have to check into the specifics depending on the country.
You should note however that due to the inherent complexity of medicinal plants substances and the limitations of analytical techniques to characterise the constituents by chemical or biological means alone, the reproducible quality of starting materials of plant origin requires an adequate quality assurance system for the cultivation, harvesting and primary processing.
Ultimately this means that the quality of your product is highly dependent on the cultivation and processing process and cannot only be characterised by the Certificate of Analysis and that you must have a way of documenting that all your cultivation activities have been done in accordance with the GACP Guidelines.
The Product IS the Process.