Page 12 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Material and product specifications
Quality, integrity and authenticity of data
Sampling procedures
Personnel training
Trend analysis, audits and reviews
Common key SOPs for QC Laboratory
QC staff should be familiar with the following key SOPs:
Management structure, responsibility and authority
Apparatus and instrument use and maintenance procedures [per instrument)
Record keeping, reporting, storage, archiving retrieval systems
Completion of laboratory records, workbooks, logs, and registers
Handling out-of-specification (OOS) conditions
Release of results from the laboratory
Sample receipt identification, labelling, handling, traceability and protection
Analytical method validation and change/updates
Computer security restrictions and data entry
Reference standards control
Laboratory calibration and performance check program
Retention samples control
Training programs
Training of personnel
Under ISO 17025, a key element for personnel is appropriate training and
documentation of all training activities. For example, operators of a
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