Page 20 - 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.
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; …
International GMPs
Batch Processing Records
4.17 A Batch Processing Record should be kept for each batch processed. It
should be based on the relevant parts of the currently approved Manufacturing
Formula and Processing Instructions. The method of preparation of such records
should be designed to avoid transcription errors. The record should carry the
number of the batch being manufactured.
Importance of record keeping
The manufacturing and testing records (along with product retention
samples) are all that remain once a batch is released.
These records are the only real source of information on a batch after it has
been released, so they must be accurate and complete.
They provide legal evidence that the company followed GMP.
There are many cases where in a legal dispute, the GMP-related records are
used in court to verify that the company followed GMP.
They are used to investigate product complaints/adverse events.
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