This standard operating procedure describes a method of keeping accurate and legible records of all work performed in GMP-regulated activities. Applicable, but not limited to, Manufacturing Batch Records, Part Number Specifications, Qualification and Validation Protocols, Equipment Maintenance and Calibration Records, Discrepancy Reports and Material and Cost Transfer forms. Procedures include crossing out, attaching data sheets, ink types, rounding off and significant figures, signatures and dating, and documenting "break" periods of multi-day activities. Contains numerous examples of significant figures and rounding.
Document identifier
DOXPUB 12-0035-SOP-1.0
Title
General Record Keeping Procedure
DOXPUB Category
Document Control
Publication date
2005-02-01
International Relationship
Latest version
DOXPUB 12-0035-SOP
History of version
DOXPUB 12-0035-SOP*DOXPUB 12-0035-SOP-1.0 * DOXPUB 12-0035-SOP * DOXPUB 12-0035-SOP-1.0
| Price |
90 vnd |
DOXPUB 12-0035-SOP-1.0
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