Page 15 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
Records that should be retained in a documentation system include records of:
raw materials
packaging materials
manufacturing
quality control testing
finished product distribution
incidents and deviations
complaints
Documents and records
Manufacturing documents should clearly define the manufacturing process, be
easy to use, and be easy to check.
There are rules as to how GMP-compliant documents and records are handled:
Standard Operating Procedures (SOPs) and Work Instructions [WIs) must be
kept current and must be readily available at the worksite.
All SOPs, WIs and batch processing instructions must be followed exactly.
Any deviations from procedures should be reported to supervisors.
Batch documents must be verified and approved before issue to
manufacturing
It is the responsibility of management to provide a documentation system that
conforms to the GMP requirements, and then train the users in the requirements
of the system.
Records are the documented history of the manufacturing process. They must
be complete and accurate, and demonstrate that authorized procedures were
followed.
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