I take my keyboard to expose a delicate situation that is currently mine today: answering to the audit remarks from our customers. On the plant where I work, we partner with 100 clients. This amount of clients represents at least 1 audit / week / year and more than a hundred remarks to manage yearly. Each client audits us on common standards but presents himself with his own requirements on how to implement these standards. And the requirement of client A is not the requirement of client B.
You will find below the difficulties multiplying the customer audits causes to a CDMO, and the solutions which are offered to you, customer, to respect GMP’s chapter 7.
The multiplication of customer audits at a CDMO poses two major issues:
We are all short of time. A client audit at a CDMO generates a significant amount of hours worked on different levels of the CDMO organization: preparation by all future interviewees, attendance on D-day, time spent answering and time spent to deploy the proposed actions.
And during that time? The plant continues to deliver with lots of unforeseen topics to manage and the axes of improvement or optimization to develop.
Take the example of the complaints answering time. Client A, according to its procedure, has an expected answering time of 20 days. The deadline for client B is 15 days. What about us as a CDMO? Do we have to manage each customer as an exception? Impossible to hold!
So we had to build our own rules. We will certainly be late in the customer B’ eyes if we set the deadline for customer A but the important thing is to meet our own deadline, isn’t it?
This example is a concrete one of what a CDMO can do if it decides to respond positively to any requirement. It can quickly end up with a quality system in “artichoke” that is to say in a succession of actions put in place just to respond to one or another remark without checking the consistency between all.
Switch to shared audits: Your CDMO plans audits with expert companies such as (http://www.intertek-france.com/), (http://www.certipharm.com/)… on common standards (GMP, ISO13485).
So join the one that suits you.
This allows the CDMO to reduce the time spent managing audits and thus improve efficiency on their answers and especially on the implementation of actions.
The BRMs will allow you to have effective work meetings on your specific problems, your current projects.