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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
The laboratory documents are designed to ensure there is linkage between the
standard procedures and test methods (what is required to do) and the
laboratory records (what was actually done). This forms the laboratory records
quality system.
LABORATORY DOCUMENTATION OVERVIEW
The laboratory quality manual and laboratory
LABORATORY policies are top level documents describing the
QUALITY overall management and organization of the
MANUALS laboratory. These documents should reflect the
requirements under GMP rules.
STANDARD Standard operating procedures provide more detailed
OPERATING and specific requirements for each of the laboratory
PROCEDURES
quality elements. For example, SOPs describe how to
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