Documentation control In a Pharmaceutical Manufacturing Company 

Standard operating procedure is the originator of the documents, in a standard operating procedure instructions are provided for doing an activity. In the same SOP a format is provided for monitoring the parameters of the activity with time etc.

This is there in the SOP at the end of the SOP as annexure, these are called formats.

Just as the SOP is required to have a SOP number these formats too are required to have the number for controlling the documentation.

These documents generally have the same number as that of the SOP and the number is revised along with the revision of its SOP.

If a SOP has xyz 001 as its number and the version is 001, then its formats will have Format/xyz/001 and version number as 001, and when the same SOP changes its version will change to 002 and Format will change to Format/xyz/002.

There can be two or more formats in a SOP accordingly the numbers are given to formats in the SOP.

These formats many times are the log books, in such events log books are prepared with these formats bound and issued to respective departments by QA. Record of issuance is maintained.

Log books are required to be bound books; spiral books should be avoided as they lead to lack of trust in inspecting authorities.

Controlling the issuance of the formats.

On every page of the formats issued, a stamp of QA mentioning date of issue of the document format and issuing person’s signature is done, QA persons sign in green ink to have clear demarcation of the ‘QA activity. The documents issued in the facility for doing work are called controlled copies, also a stamp of the word “controlled “is fixed on the document.

Documents issued to outside parties may not remain under the control of the QA of the pharma manufacturer, hence such documents are always stamped as “uncontrolled” copy.

QA is required to issue loose pages of the formats of SOPs for doing work by any department, such formats issue is recorded in the log book which controls the issuance of the formats.

Finally, reconciliation should be done to ensure the proper usage of the blank formats issued. In the event of missing documents, it should be verified and investigated further.

Reviewed and complete documents should be stored properly till the specified period as required by local Drug Control Authority or FDAs


Leave a Reply

Don`t copy text!
%d bloggers like this: