Sunday, May 24, 2009

Regarding Process validation of tablet manufacturing?

Details:
In tablet manufacturing process, during validation can we do the process with out fixing the limit for process control parameters for example dry the granules till LOD or Moisture content achieved and vary the RPM of compression machine? Also can we continue the tablet compression with out waiting for blend report and initially compressed tablet dissolution analytical report can we collect these data like during validation and then fix the parameters after the validation based on validation batch results?

Expecting an expert opinion.

Thanks
Regards,
K.Saravanan

No comments:

Pharmaceutical Validation Documentation Requirements

Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...