sop for document control system

sop for document control system

1.1 The objective of this SOP is to define the procedure for document controlling system.
2.1 This SOP is applicable for document control system
3.1 Asst. Officer or above – Quality assurance-Prepare the SOP and follow-up the SOP accordingly
3.2 Asst. manager –Quality assurance -Provide the support to the implementation of SOP and maintained the records.
4.1 Head – Quality Assurance / Chief Executive Officer
5.1 In-House

6.1.1 Master document (i.e. MFR, STS & STP, stability study report, SOP, Artworks, layouts, site master file, formats, approved vendor list, validation/qualification protocols etc.) shall be prepared by concerned departmental personnel, checked by department head or his/her designee and approved by Head-QA. Concerned department shall prepare and QA shall maintain the master list of documents.
6.2.1 Only QA department shall retain soft (computer) copy of all documents. QA department shall store the computer copies in document-wise folders. In these folders create another two folders named as ‘Controlled Documents’ and ‘Obsolete Documents’. ‘Controlled Documents’ folder shall store current controlled documents. While ‘Obsolete Documents’ folder shall store all obsolete documents.
6.2.2 QA personnel shall affix “Master Copy” stamp in red colour on the right top corner of each page with sign & date.
6.2.3 Whenever required to issue the copy of documents to other department QA personnel shall make photocopies from master copy and put “Controlled Copy” stamp in green colour or “Display Copy” stamp in blue colour near the master copy stamp with sign and date.
6.2.4 QA personnel shall enter in “Document Issuance and Retrieval Register” as mentioned in Format and STS & STP Issuance and Retrieval Register as mentioned in Format and handover the document to concerned department and take receiving of concerned person in “Document Issuance and Retrieval Register” with sign and date.
6.2.5 “Controlled Copy” of document shall be filed and “Display Copy” shall be displayed in respective area.
6.3.1 At the time of distribution, QA personnel shall retrieve and destroy all distributed controlled copies or displayed copies of previous revision of documents by shredding into the small pieces.
6.3.2 QA personnel shall maintain record of the same in “Document Issuance and Retrieval Register” as mentioned STS & STP, Format
6.3.3 QA person shall put “Obsolete Copy” stamp in red colour with sign & date on each page of master copy of revised document.
6.3.4 Fill the details of obsolete documents in “Obsolete Document Register” as per Format
6.3.5 QA personnel shall save computer copy of above obsolete documents in ‘OBSOLETE’ folder computer of QA.
6.3.6 After completion of filled controlled documents concerned departmental person shall be submitted to QA department for review and storage of documents as per SOP
6.3.7 Documents can be discontinued in following conditions: In case of any existing procedure needs to be discontinued. In case of any machine/equipment/department is shifted to another location. In case of any machine/equipment/department is permanently removed from the plant.
Note: In above three conditions, concerned department shall surrender all respective controlled copies of documents to QA department. QA personnel shall destroy all these controlled copies of master copies. Filled documents to be kept in QA department as per SOP
6.4.1 Concerned department shall send requisition as per SOP on Format to QA department for issuance of records (annexes of SOPs) for data filling on routine basis.
6.4.2 As per above requisition, QA personnel shall make the photocopies from “Master Copy” red colour and stamp as “Controlled Copy” in green colour on the photocopies of documents with sign & date on each page near the “Master Copy” stamp.
6.5 In case if a copy of any document (master copy or controlled copy) is required to be given to outside agency, its photocopy shall be done with permission of Head QA. QA person shall stamp “Uncontrolled Copy” in black colour ink at the right side on bottom of each page of Document
6.6 If any CONTROLLED COPY of document is spoiled or lost at the concerned department, Head of that department shall fill “Requisition form for additional controlled copy of document” as per Format and forward to Head QA. If filled requisition found satisfactory, Head QA shall approve the form with sign & date and put remark (destroy the old controlled copy of spoiled document and in case of lost the document, destroy the old controlled copy if found after re-distribution).
6.7 When any change required in documents, concerned department shall take the computer-copy of that document from QA department after approval of Head QA and incorporate required changes into that document with the change control as SOP and follow further procedure as per point no. 7.1 to 7.3.
6.8 In case of if any department required filled document follow the SOP


SOP : Standard Operating Procedure
QA : Quality Assurance
MFR : Master Formula Record
STS : Standard Testing Specification
STP : Standard Testing Procedure









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