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Optimisation, Qualification and Validation Strategy
We
were commissioned by an International Injectable Products Laboratory
to ensure conformity of Cleaning in Place (CIP) processes in preparation
for an FDA Audit.
The client set the following requirements:
- To gain complete control of the CIP process.
- To ensure automated process controls which affect quality of the CIP flag up all errors to operators.
- Minimise the number of non-compliance cycles by making the system more reliable
- Implement a Validation Strategy and Quality Plan
Scope of Services:
- Identified critical parameters and established which of these impact the effectiveness of the CIP.
- All automated programmes controlling CIP were studied and improved to ensure permanent control of critical parameters.
- Where possible CIP cycle time was optimised.
- Modified the automation programmes and qualified them in IQ and OQ.
- Implemented the Cleaning Validation strategy.
- Performed Cleaning Validation in partnership with Client Validation Department.
Results:
Thanks to our methodology modifications to the system were made without disrupting production.
Weaknesses in the production were identified earlier, which made the analysis process more efficient.
The changes made allowed the client to undergo their FDA audit with confidence.