PDH Pharmaceuticals Pvt Ltd follows a well-established system for the control of documents. All departments follow the control of documents. The standard operating procedure is developed for effective control of documents. All related documents SOPs, Work instructions of production, QA, QC, and maintenance, are controlled documents. Each document has a unique code, revision number, and issue date. A document approval box is placed on the title page of each document which contains the author, review, and approval from a respective person.
After approval of document, it is stamped with a master stamp. This master document is retained by QUALITY ASSURANCE (QA). Distribution is carried out by making copies of master document and each copy bears a controlled stamp in blue with a unique copy number assigned to each individual recipient during distribution. Distribution Record is maintained for each specific document with QA. A document change process is present. Any concerned person can raise document change request (DCR) in case new revision / amendment of a particular document is required. After raising DCR, it is submitted to QA for review. If QA approves the change then respective document is revised bearing unique revision number. Previous revision of document is stamped as obsolete in red and retained along with distribution record till next revision is arrived. All controlled copies of obsolete document are shredded and new revised document is master stamped and new distribution record is generated.