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Cleaning validation establishes that the cleaning procedure can effectively remove product residue from pharmaceutical equipment to an acceptable limit.
Cleaning validation is a critical step in the pharmaceutical manufacturing process that ensures the safety of patients by preventing cross-contamination of active ingredients (APIs) with microbes and chemical residues.
Ineffective cleaning processes can lead to batch failures, downtime, FDA rejection, and costly fines due to drug adulteration.
Cleaning Validation is Important because it:
▪️Prevents cross-contamination
▪️Improves the quality of pharmaceutical products
▪️Eliminates recalls
▪️Confirms the quality of the process
▪️Satisfies customer requirements
▪️Contributes to regulatory requirements
Cleaning validation involves proving the effectiveness and consistency of cleaning in pharmaceutical production equipment.
For example, cleaning procedures should be validated to avoid carryovers of materials into the next batch of the API.
What is a cleaning validation protocol?
A cleaning validation protocol can guide you through the entire validation process.
A cleaning validation protocol should include the types of testing required, acceptance criteria, sample locations, sampling plan and procedures (e.g., swab or rinse samples), analytical and microbiological test methods to be used, etc.
The validation protocol also has instructions for the cleaning sequence, cleaning agents, and period of cleaning.
The protocol should have guidelines on how to manage failed results.
Cleaning validation covers the entire cleaning process, from selecting cleaning agents, sampling procedures, setting up acceptance criteria, testing, and recording.
If you must adopt a protocol change, include the protocol change management approach.
