What is a CoA?
CoA is the abbreviation for ‘Certificate of Analysis’. This document is in some cases supplied with originally manufactured pharmaceutical products , i.e. a RMP / RLD. A batch-specific CoA is issued with each batch release by the manufacturer. However, manufacturers of medicinal products for human use are not obliged to supply these documents and it is therefore not easy to obtain. This document contains some basic data of a particular batch release and can help analytical scientists to prepare their characterisation study. A new CoA is issued with each batch release from a manufacturer. Customers can purchase the available CoA for an additional fee.
Why are CoAs only available for some products?
In general, pharmaceutical products are licensed by an international or national authority. In Europe, the EMA (European Medicines Agency) is the regulatory authority with which all EU medicines are registered. During the registration process, the applicant submits all necessary documents to assess the safety and efficacy of the manufacturing process. Detailed information on many aspects of the manufacturing, handling, storage and distribution process is kept at the Agency. The Agency assigns an EU registration number under which each product can be uniquely identified.
Once the Agency has granted the applicant manufacturing and distribution rights, all processes described to the Agency must be maintained and followed. However, the holder of the manufacturing and distribution licence (authorisation) is not obliged to provide further documentation when reselling his medicines to hospitals, wholesalers or pharmacies. This includes the certificate of analysis. The manufacturer is free to provide a CoA to the customer.
Can Evidentic obtain CoAs for products which I have in my lab?
We work together with a large network of pharmaceutical suppliers. In some cases it will be possible to obtain CoAs products that you have purchased from a source other than Evidentic. However, all CoAs that Evidenic can offer for our own products will be shown on the CoA product page – in other words: what you see is what you get!
We can also advise you for which products CoAs are available in Europe and for which products this is generally not possible. Just ask us!