DOXPUB 12-0035-SOP-1.0

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.

Product Details

Edition:

1

Published:

02/01/2005

Number of Pages:

6

File Size:

1 file , 150 KB