Good Documentation Practice eBook

Training outcome of the module:

Good document practice is the single most essential step in assuring your products are safe, pure, effective, and traceable. Manufacturing instructions should clearly and accurately define each manufacturing process step. While conducting processing operations you must record all the steps which are called batch production records.

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 GMP rules do not allow companies to use draft, trial, or out-of-date documents in commercial manufacture.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.

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