Audits - Ofidit
Qualification of starting materials is an old topic by now. Nothing new. The guidance is clear. However, in reality there are still some very practical issues. For instance when Ofichem’s customers purchase only small amounts and are simply not welcome to audit the supplier.
Based on recurring requests of customers Ofichem started a Shared Third Party auditing program (STP auditing program) focusing on the suppliers in China. Since 2016 these activities are being executed by an independent business unit Ofidit.
The reason we conduct this service via this independent business division Ofidit is because:
Main issue would be a possible conflict of interest, since Ofichem is a trader. However, conflicts of interests are generally solved by an independent QA department, whereas the general direction commits to respect the QA decisions.
- Lab Ofichem is the API manufacturing company (GMP-certified) of the Ofichem group. The STP auditing program would be part of the responsibilities of the QP of Lab Ofichem, not the responsibility of the trading company Ofichem.
- Lab Ofichem wants to perform serious audits, really assessing the risks from an ICH Q7 perspective and monitoring the follow-up closely. The STP auditing program won’t be a generation of approval reports that can be bought afterwards by every company that buys the product.
Ofichem performs the audits using a trained and certified auditor.
Our auditor would report the findings and classify the deficiencies (critical, major, other). Conclusions about approval would not be part of the report. This is for each company to decide. Our Auditor would perform the follow up on the CAPA and keep the shared parties updated on the status.
Despite some other STP audit programs we intend to keep the costs of participating very low, which is perfectly possible if many companies are willing to participate.
Information about participating companies will be kept strictly confidential and is not shared between participators. Ofichem acts as a contract acceptor in the light of chapter 7 of the EU GMP guidance.
If you are interested please sent an email to email@example.com
Download here the full STP audit program.