Page 26 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
Component, drug product container, closure, and labeling records.
Master production and control records.
Batch production and control records.
Production record review.
Laboratory record systems including electronic data systems and
analytical methods.
Distribution records.
Annual Product Reviews
Complaint files.
Validation and qualification systems of processes and equipment.
Equipment calibration and maintenance records.
Environmental monitoring records.
Training records.
Components of documentation systems
All documentation systems should have approved and established SOPs that
govern how the particular documentation system is managed. The topics that
should be included, at a minimum are:
Document control and distribution.
Approving bodies and date of approval.
Timeline for review and revision.
A tracking and follow-up method.
Assurance of training regarding documentation.
A description of the purpose of the system.
Storage and retrieval information.
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