Production of excipient for a medical device
Could you please provide your opinion on the operations of two companies involved in the production of an excipient intended for marketing as a medical device? The period is between 2015 and 2018 in Europe.
Company A is the medical device manufacturer company with its own ISO13485 certification and CE.
Company B is the actual manufacturer and supplier of the main chemical molecule (the excipient).
The two companies signed the production contract and quality agreement in the third quarter of 2015.
Company B is not a GMP company and only holds ISO9001:2008 certification. Company B was audited at the end of 2014. 15 non-conformities were found, which were closed in December 2015. In the meantime, however, several batches were produced and delivered to Company A. The rules were supposed to be changed in March 2016 with the introduction of risk assessment (please confirm this). However, the two companies continued to operate until mid-2017 without evidence of having taken corrective actions. In late 2017, some supplies were contaminated and the supplies were interrupted. The two companies agreed to rework to resolve the problem and restart supplies. At the end of 2017, Company A issued a Quality Summary Report declaring Supplier B suitable for the production of the molecule, based on the 2014 audit and the 2015 QA, without making any mention of the defective supplies.
Question is if the process followed presents irregularities