Page 2 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
Training Outcome of the Module:
After completing this module, you will be able to:
Recognize the importance of procedures
Recognize the importance of record keeping
Identify the possible consequences of not completing and certifying GMP
documents
Identify how to complete batch records and associated supporting documents
Manufacturing instructions should clearly and accurately define each
manufacturing process step.
Production operators should rely upon following these approved steps of
manufacture, not draft instructions. GMP rules do not allow companies to use
draft, trial or out-of-date documents in commercial manufacture. The
instructions, however, should be based on experience with completing the tasks.
If problems arise, the procedures should be revised to reflect exactly what is
required.
What do the GMP rules say?
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