SOP on Document and Data Control
Objective : To lay down a procedure for control of Documents and Documented Data.
Scope : This Standard Operating Procedure is applicable for the control of documents and documented data of all the formulation plants/ operations.
Responsibility : All HODs shall be responsible to follow this SOP for maintaining control on all documents and documented data or records.
Incharge, Documentation Cell of Quality Assurance or his/ her designee shall be responsible to maintain (or to control) the documents as per this SOP and shall review the documents for compliance with the relevant documentation procedures.
Head or Incharge, QA or his/ her designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions
TDs :Technical Directions; approved set of instructions for the manufacture of the product
Documents : Controlled Quality documents like TDs, SOPs, Specifications & STPs/ GTPs, Protocols, etc.
Master Copy : The original set of controlled documents or written procedures which shall be retained at Documentation Cell of Quality Assurance and shall always possess the stamp ‘MASTER COPY’ on the front side of every page.
Controlled Copy : The photocopy of the master copy of controlled documents(like SOPs, STPs, GTPs etc.) or written procedures which shall be distributed to the user department(s) as a part of document distribution procedure and shall bear a stamp as ‘Controlled Copy No.____’ and initials of the concerned personnel. These documents are controlled documents and are retrievable whenever superseded.
Uncontrolled Copy : The photocopy of master copy of controlled documents or written procedures which shall be given to any department or person for reference purpose only. These documents are not controlled documents; hence are not retrievable.
Procedure : Generation of Documents
SOP titled ‘Preparation, Approval and Control of Standard Operating Procedures’ shall be referred for generation of SOPs.
SOP titled ‘Preparation, Approval and Control of Operating Guidelines’ shall be referred for generation of Operating Guidelines.
SOP titled ‘Preparation, Approval and Control of Specifications and Standard Test Procedure for Raw Materials, Packaging Materials, In-process Materials and Finished Products’ shall be referred for generation of Specifications and STPs.
SOP titled ‘Preparation, Approval and Control of General Test Procedures’ shall be referred for generation of GTPs.
SOP titled ‘Preparation, Approval and Control of Technical Directions for Manufacture of Drug Products’ .
SOP titled ‘Preparation, Approval and Control of Technical Directions for Manufacture of Active Starting Materials at Contract Manufacturing Location’ .
Validation Master Plan shall be referred for generation of Qualification and Validation documents and SOP titled ‘Assigning of Numbers for Qualification Documents, Protocols and Reports’ shall be referred for assigning numbers to these documents.
Note: Study protocols of regulatory importance like Process Validation Protocols, Analytical Validation Protocols, Stability Protocols, etc., which shall be generated by R&D and approved by QA, shall be numbered as per SOP ‘Assigning of Numbers for Qualification Documents, Protocols and Reports’ .
Control of Documents
The drafts of all the controlled documents once finalized after drafting-by initiator department-and-review-by QA department-process shall be finally printed out at Documentation Cell of Quality Assurance. Master copies and controlled copies of these documents shall be prepared.
All documents including validation documents like validation protocols/ reports, qualification documents, etc shall be under the control of Documentation Cell of Quality Assurance department.
Like other controlled documents, master copies of the validation documents shall also be retained by Documentation Cell of Quality Assurance. Controlled copies of these documents, if needed, shall be distributed to user and/ or functional department(s).
Documents like SMF, VMP, Quality Policy and Quality Manual shall be kept at the Documentation Cell of QA. The review and/ or revision of these documents shall be undertaken by Quality Assurance, whenever required.
Master Copies and Controlled Copies of the Documents
Documentation Cell of Quality Assurance shall be responsible for printing of finalized controlled documents and then preparing of master copies and controlled copies of the documents
The Master Copy of the concerned document shall be prepared by stamping ‘MASTER COPY’ using blue ink, on the front lower middle non text part of each page. Each page shall be initialed by the person who has made stamping near the impression of the stamp.
Master Copies of all the documents shall be retained with Documentation Cell of Quality Assurance.
For preparation of controlled copies of a document, photocopies of its master copy shall be taken on white A-4 size paper of good quality using one side of the page.
Quality of photocopy of master document should be legible.
Photocopies shall be taken by an authorized QA person.
Wastage of photocopy (ies), if identified, due to bad quality of photocopy (ies) shall be undertaken by destroying this(ese) photocopy(ies) manually or by other convenient means.
Each page of the controlled copy shall be stamped as ‘CONTROLLED COPY No.___’ using green ink, preferably on the right hand side of bottom of each page and not on text part, with initials of the person who has made stamping.
Number to the controlled copy shall be assigned by Documentation Cell of QA as 1, 2, 3, 4…….and so on, depending upon the number of departments or persons where the distribution shall be undertaken.
While issuing an uncontrolled copy of the document, the same shall be stamped as ‘UNCONTROLLED COPY’ using red ink, preferably on the text part, on every page of the document, with initials of the person who has made stamping.
Distribution and Retrieval of the Documents
All the controlled documents shall be distributed and retrieved by Documentation Cell of QA.
Distribution and retrieval of the concerned document shall be done using the form titled ‘Document Distribution and Retrieval Record’ as described.
QA Personnel shall be sending an IOM with a number along with the documents to be Distributed / Retrieved from concerned department if in case the distribution is outside location.
The Numbering shall consists of 17 alphanumeric characters and written as IOM/QA/00/25-0000 where 1st three characters stands for IOM, 4th character is a slash, 5th &6th characters shall denote department name sending the IOM, 7th character shall denote slash, 8th &9th character shall denote the month, 10th character denotes slash, 11th &12th character shall denote year, 25th character denotes dash and 14th & 15th 16th & 17th character shall denote the serial no. of IOM.
All Concerned Departments shall be responsible for sending back Acknowledgement of IOM after receiving it with retrieved documents and send back the preferably the signed hard copy or Scanned copy, Fax of IOM back to QA department.
QA department shall maintain the record of IOM’s send to concerned departments.
Additional controlled and/ or uncontrolled copies of the documents, if required, shall be requested through a form titled ‘Requisition for Additional Controlled and / or uncontrolled copy’ as described. Incharge, Documentation Cell of QA or his/ her designee shall issue additional controlled and / or uncontrolled copy only after receiving/checking the completed form.
The retrieved controlled copies of the document shall be destroyed by Documentation Cell of QA.
Review and/or Revision of the Documents
The documents like SOPs, Specifications, STPs, GTPs and TDs shall be reviewed biennially i.e. after every two years. These documents, if require amendment in the procedure before their review period can be revised thorough change control procedure mentioned in SOP titled ‘Change Control’
All the controlled documents shall be reviewed within two months before and after the ‘Review Date’ assigned on the concerned document.
Review of documents shall be initiated through ‘Document Review Form’ by Documentation Cell of QA.
Documentation Cell of QA shall intimate the initiator department to initiate review process through Document Review Form.
Initiator department shall undertake review of the concerned document and shall put its comments on the Document Review Form.
Initiator department shall forward the Document Review Form with comments to Quality Assurance.
QA shall check the comments. If required, QA can send back the same to the initiator department for further information on the subject and/ or to other department(s) for the comments, if required.
After receiving the filled form from the concerned department, QA shall dispose the review process, in following manner.(Also refer ‘Flow chart-Document Review and Revision Process’ )
The document that needs revision shall be revised through change control procedure as defined in SOP titled ‘Change Control’ and that which does not need revision or change shall be processed in following manner.
If there is no change in the text of the SOP the same shall be checked for the compliance for Format of the document, if the format is a part of any SOP.
If the format matches with that mentioned in the current relevant SOP, the document shall be stamped as per the procedure indicating ‘Review’ undertaken.
If the Format does not match with that mentioned in the current relevant SOP, the document shall be reprinted in the current applicable format changing its ‘Revision No.’ wherever applicable.
Stamping Procedure: The concerned Master Copy of that document shall be stamped in blue ink on the front side(Top middle) of the document bearing following
Reviewed and Approved by Sign/Date
Next Review Date :
QA person who shall review and approve the document shall be authorized by Head-QA. The same shall sign in the column ‘Reviewed and Approved by’ followed by the date on which the review has been taken.
‘Next Review Date’ shall be the date on which the review of the same document shall be undertaken in future. For example, in case of SOPs this shall be two years from the originally assigned ‘Next Review Date’.
Controlled copies of that document are prepared. The controlled copies are distributed /retrieved.
QA person shall put another stamp in blue ink bearing following information on front side of every page of the document over the ‘Next Review Date’, wherever applicable. REVIEWED
With the option of stamping procedure, review of the relevant document shall be done once only. The next review of the same document shall be done through reprinting with change in its revision number (without raising change control for no change).
In case of change in the Form of SOP which does not invite change in the text of SOP, the concerned form shall be revised through the form titled ‘Revision of SOP Form’.
Any concerned department can raise the request (through ‘Revision of SOP Form’) for making desired changes and shall forward the request to Quality Assurance.
Note: During review period, if the reviewer proposes change in the attached forms of the concerned SOP but not in the SOP text, the document shall be reviewed through Stamping Procedure as discussed and simultaneously the concerned form shall be revised through ‘Revision of SOP Form’
Quality Assurance shall assess the proposed changes. If proposed changes are acceptable to QA, then QA shall forward the request with its comments to Documentation Cell of QA.
Note: QA can seek comments/ inputs from other concerned department(s) on the proposed changes, if required.
Documentation Cell of QA shall modify the relevant form for the proposed changes and make distribution (of modified form) and retrieval (of superseded form) after preparing its master copy and controlled copies and shall make relevant replacement in master copy and controlled copies of the concerned SOP with the master copy and controlled copies of the modified form respectively.
Printing of SOP forms from outside sources, whenever required, shall be undertaken by Incharge, Documentation Cell of QA after approval from head, QA. These printed forms/ logbooks shall be issued against requisition by internal communication, from Documentation Cell to user department by Incharge, Documentation Cell of QA or his/ her designee and issuance shall be recorded for ‘date of issue’ ‘issued to’ ‘no. of pages’ as applicable in a register.
Master lists of the Documents
A master list of the documents based on type of document i.e. Specifications/ STPs, GTPs, SOPs, TDs, etc. shall be prepared by Documentation Cell of QA and shall be circulated, if needed, to different departments. The master list shall include the following, but not limited, information:
- Name of initiator or user department
- Title of the document
- Document number
- Revision number
- Effective date or Issue date
- Next review date
- Date of Stamping, if applicable (indicating review undertaken)
A list of all master lists of the quality documents shall be prepared and distributed, if required, to different departments, whichever applicable, by Incharge, Documentation Cell of QA or his/ her designee.
Incharge, Documentation Cell of QA or his/ her designee shall prepare a matrix of all the quality documents and records indicating their various features.
Handling of Records
Each concerned department shall be responsible to fill all the records relevant to the approved written procedures.
The documented data or records shall be forwarded to Documentation Cell of QA at appropriate intervals.
Documentation Cell of QA shall prepare a consolidated list of records of GMP importance as indicated. The list of records may not be limited to those that are mentioned.
Each concerned department shall help Documentation Cell of QA in maintaining the reference documents (like machine manuals, etc.) and literature cross-referred in preparing the documents like SOPs, protocols, etc. at Documentation Cell of QA.
Documents and Records at Contract Manufacturing Sites
Distribution and retrieval of documents applicable at contract manufacturing locations shall be controlled by Documentation Cell of QA department in conjunction with Contract Manufacturing Department.
The records related to the manufacture of a product at contract manufacturing location shall be maintained to the period of not less than one year after the expiry date of the product being manufactured at the respective contract manufacturing.
Batch manufacturing records (BMRs) shall be maintained by the quality assurance department of contract manufacturer for a period of not less than one year after the expiry date of the last batch being manufactured at the respective contract manufacturing location.
Note: Adequate control of records at contract manufacturing locations shall be ensured by making regular audits by Quality Assurance and Contract Manufacturing Departments.
Destruction of Documents and Records
Retrieved controlled copies of superseded documents shall be destroyed by Documentation Cell of QA using paper shredder machine or manually or through incineration and the relevant recording shall be done on the form in Document Distribution and Retrieval Record.
Master copies of all the superseded written procedures shall be stamped with ‘OBSOLETE’ by Incharge, Documentation Cell of QA or his/ her designee, on the front side (on text part) of all the pages, in red ink.
All the obsolete master copies of superseded documents shall be maintained for a period of not less than seven years from the date of obsolescence of the document. After seven years the obsolete master copies shall be destroyed by Incharge, Documentation Cell of QA or his/ her designee using paper shredder machine or manually or through incineration.
Incharge, Documentation Cell of QA or his/ her designee shall record the details of destruction of obsolete master copies/ documents in ‘Documents/Data Destruction Record’.