Page 24 - Introduction QC

GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com

reference to the calibration procedure

results of the calibration

statement of compliance, or otherwise to a
reference standard

signature of the person performing the
calibration

traceability to the ISO standard, if applicable

SOPs are usually written according to the company
structure and template. This is a typical table of
contents for regulated SOPs:

Scope and Application

Responsibility
STANDARD Materials and Equipment
OPERATING

PROCEDURES Definitions and Precautions

Detailed Procedure

Change History

Approval

Related documents and references

Laboratory test methods are critical documents that

must be followed exactly when performing a test. Test
methods usually have the following features:
TEST
METHODS names of those who authored, reviewed, and
approved the test method

document and version number

scope and application

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