Dear all, regarding question 20 “Is the effective date of the change (completion date) recorded and when appropriate the first batch manufactured recorded?” we are not sure how to handle it for multi-product changes. At our site we manufacture products of different customers. Sometimes we have changes, where f.e. documents of several products need to be adapted. How are the requirements defined in such cases? Do we need to report the first batch only once or for each productCorrespondent
This request comes from my post “29 questions to ask about your change management/change control system.”
At heart, this requirement is to help meet the regulatory requirement that “After implementation, an evaluation of the change should be undertaken to confirm the change objectives were achieved and that there was no deleterious impact on product quality.” (ICH Q9 part IV.B.3.d)
In order to perform an evaluation, you must be able to know when to start. This evaluation must be able to be performed on each and every product. It is from here we can settle on 1st batch. There are lots of ways to do this. The requirement is, for each and every product, to be able to state definitively when the change was first applied to the product.
We can drill down to the most definitive guidance on GMP Change Control, the PIC/S Recommendation “How to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management” which further strengthens the requirement:
|5.4. Change Review and Effectiveness||Changes are monitored via ongoing monitoring systems to ensure maintenance of a state of control, and lessons learned are captured and shared/communicated. (Note: Activities such as Management Review, Annual Product Quality Review, Continuous Process Verification, Deviation Management and Complaint Monitoring can be useful in this regard.)||Having that definitive point allow all these activities to be effective.|
The requirement is clear. We need to be able for any given change identify when it started impacting product.
All of the various Annual Product Review/Product Quality Review requirements also require the ability to evaluate all changes to the product in a given time frame.
Like many such requirements, there are multiple ways to do this. I think the requirement to capture first batch in a change control really stems from it, in many ways, being the easiest to do as you only have to manage it in the change control workflow. Though, in all honesty, it is also darn annoying with changes potentially being open more than a year to capture all possible products.
Based on our core requirement, there are several factors to consider:
- There must be a way for a user to easily determine when a given change impacted a given product and to determine if a given batch was impacted by the changes
- The user must be able to link any batch to all the changes that impacted it
- The user must be able to run a report of all changes that impacted a product in a time frame
There are multiple ways of solving for this from the put a field in the change control to set of interfaces between the ERP and eQMS (and maybe MES).