Page 9 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
What do the GMPs rules say?
US FDA CFR 211
§ 211.188 Batch production and control records, (extract)
Batch production and control records shall be prepared for each batch of drug
product produced and shall include complete information relating to the
production and control of each batch. These records shall include:
(a) An accurate reproduction of the appropriate master production or control
record, checked for accuracy, dated, and signed;
(b) Documentation that each significant step in the manufacture, processing,
packing, or holding of the batch was accomplished, including:
(1) Dates;
(2) Identity of individual major equipment and lines used;
(3) Specific identification of each batch of component or in-process material used;
…
International GMPs
Chapter 4 Principles
Good documentation constitutes an essential part of the quality assurance
system. Clearly written documentation prevents errors from spoken
communication and permits tracing of batch history.
Specifications, manufacturing formulae, and instructions, procedures, and
records must be free from errors and available in writing. The legibility of
documents is of paramount importance.
Specifications
To ensure consistent quality of materials and product, there are written
specifications for all:
Starting materials
Packaging materials
Intermediate products
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