“Understanding Master Copy, Control Copy, and Obsolete Copy in the Pharmaceutical Industry”

In the Pharmaceutical industry document issue is very important and every document is traceable and accountable in the form of master copy, control copy, and obsolete copy. These master, control, and obsolete copies refer to different versions of official documents related to official procedures like standard operating procedures and BMR versions like ineffective documents under review, etc.

1.  Master Copy: This is also called the original document marked as ” Master Copy ” with a stamp on the pages of a document with a blue stamp. This copy is a controlled version, and it is secured in such a way that unauthorized changes cannot be made in this document.
2. Control Copy:  These documents are issued for operational use areas. These are photocopies of the Master copy and are stamped in red ink. These are issued to user departments as per the distribution list and users fill follow the procedures in this document.
3. Obsolete Copy: The document which is no longer in use are called obsolete documents and these are previous versions of documents and are no longer in use and are ready for shredding or archived. These are stamped in red ink as obsolete and most of times soft copy is retained and hard copy is shredded.

Document control in pharmaceutical industry is very critical and it directly reflects on the product quality, operational efficiency of the company and also the company’s interests towards regulatory compliance. Controlled documents ensure regulatory compliance and reflects on companies’ quality policy and standards. Uncontrolled documents are risk to the companies, and these are one of the audit findings.