Page 6 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Reporting results
Each product has a specific set of specifications
registered with the government authorities.
Starting materials and finished products are
required to be tested to these specifications, and
the results reported to QA management if there
is a problem.
Batches may not be released to the market if
results do not conform to the approved
specifications.
Laboratory documentation
Laboratory documentation and records must
follow the same rules as manufacturing GMP
documents. The QC lab is required to have
SOPs, test methods, specifications, registers,
logs and testing records in place.
These documents must be current approved,
accurate, provide traceability and be archived
for later review. Government auditors are
particularly interested in the QC testing records
when they conduct GMP audits.
Sections of ISO 17025
The two main sections of ISO 17025 are Management (Section 4) and Technical
Requirements (Section 5), which are together broken down into the key areas
shown in the diagram below.
Organization, Management and Quality Systems
4.1 Organization
4.2 Management System
4.3 Document Control
4.13 Control of Records
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