Microbiological Monitoring to decide campaign length for Tablets

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear Friends,

Would you consider performing microbiological monitoring as part of the Cleaning Validation Program to decide number of batches in a campaign (approx 21 batches) for solid dosage form specifically Tablets? Is it worth taking samples at pre-determined interval of 5, 10, 15 and at the end of the campaign and test the samples for cfu counts or the chemical cleaning validation is sufficient to support the number of batches in any campaign.
Any suggestion in this area will be highly appreciated.

Rgds
Shrini

2

Dear Shrini,

we have validated our campaign length from the microbiological point of view, as you describe. The only difference was that we did not take samples at intermediate batches (it is only useful if you suspect a potential failure from the last batch), but we included, as a worst case, a last batch that had been kept for the longest holding time of the granulate before compression.

Best regards

Alfred