GMP Compliance and regulatory approval

We monitor that Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with Specifications
Any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language and are well documented. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

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