1. Objective :

To lay down procedure for usage of stamps for issuance of documents by QA.

  • Scope :

This procedure is applicable to all documents, which are issued by QA to other departments.

  • Procedure:

A.Master Copy:

It is the final approved / authorized copy of any document which is maintained by QA & stamped as “MASTER COPY” on top centre of each page.

B. Controlled Copy :

  • When photocopy of the master document is issued to concerned departments for their reference purpose , it shall be stamped as “CONTROLLED COPY” on top right corner of first page & remaining pages shall be stamped as “CONTROLLED”.
  • QA shall keep record for all the issued controlled copies.
  • In case of revision of any Master document, QA shall issue revised controlled copies to the Dept., retrieve back all the superseded copies & destruct them.

On First Page

On Remaining Pages

C. Uncontrolled Copy :

  • In case where any document is required by any outside agency or external customer, it shall be issued by QA by putting stamp of “UNCONTROLLED COPY” on top right corner of each page.
  • Usually no record is maintained for Uncontrolled Copy.

D.Reference Copy:

  • In case any internal customer requires copy for reference purpose, then it shall be stamped as “REFERENCE COPY” on top right corner of each page.

E. Obsolete:

  • In case of revision of any Master Document, superseded (old) copy of master document shall be stamped as “OBSOLETE” on top right corner of each page.
  • All the controlled copies of supersede document shall be retrieved back & destructed as per their procedure.

F. Void :

  • When any product is discontinued or production planning is cancelled, then all master documents related with it (SOPs, BMRs, Specs, Test data sheets etc.) shall be stamped as “VOID” on top right corner of each page.
  • All the issued controlled copies of void document shall be retrieved back & destructed as per their procedure.

G. Implemented As Such :

  • In case of any corporate SOP is directly adopted at site, then photocopy of Corporate SOP shall be stamped as “IMPLEMENTED AS SUCH” on centre bottom of first page.

H. General Instructions :

  • Keep all stamps under lock & key always.
  • Color of stamp can be changed as per different company’s procedures.
  • In case of Electronic stamp, there should be a defined list of persons from QA who can have access of issuance of Documents electronically.

For any feedback or suggestions write to us at info@pharmastate.com