SOP On Document and Data Control
To lay down a procedure for control of documents and documented data.
This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location.
- All HODs shall be responsible to follow this SOP for maintaining control on all documents and documented data or records.
- Documentation Cell personnel of Quality Assurance 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 QA or his/ her designee shall be responsible for compliance of this SOP.
Accountability: QA Head shall be accountable for implementation of this SOP.
Abbreviations and Definitions
STPs : Standard Test Procedures
GTPs : General Test Procedures
SOPs: Standard Operating Procedures
SMF: Site Master File
IOM: Inter Office Memo
VMP: Validation Master Plan
Documents: Controlled Quality documents like BMR, 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 These documents are controlled documents and are retrievable whenever superseded.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.
All documents shall be the part of QMS documents and QMS shall comprises the followings:
Quality Manual: The Quality Manual shall contain a statement of the company’s Quality Policy and Quality Objectives of the organization. It shall include the systems being followed for the implementation of the Quality Policy. The organograms, responsibilities and authorities of the personnel operating the systems shall also be indicated in the manual. Quality Manual shall be prepared by QA personnel and shall approved by QA Head.
Master Documents: These are detailed documents for implementation of Quality Management System covering all activities that individually or collectively influence the quality of a product, whether directly or indirectly. These include facility Layouts, Master Formula Records (MFR), Batch Manufacturing Records (BMR), Batch Packing Records (BPR), Specifications and Standard Test Procedures of materials and product, Qualifications / Validation protocols and S These documents are prepared by user department personnel and shall approved by QA Head.
Records: Records can be categorized as:
Primary records (original raw data):g. executed Batch Records, Analytical Records, Log Books, Maintenance Records, Calibration Records, Temp-RH Records, Pressure differential records.
Secondary records/documents: these are generated as report/certificate using primary raw data.
Sundry Records / documents: These are records/documents which do not have direct affect on GMPs.
All the documents shall be prepared by taking into account the relevant statutory requirements.
All documents shall be identified and traced by a unique title & unique document number.
Any allotted document number must not be allotted to any other document.
Issued Approved documents may be corrected manually by QA personnel with a pen and signed for minor corrections (only if the correction is formed by any grammatical/ typographical/ spelled error) same shall intimated to QA Head. If permitted by QA head same correction shall be done in master copy. In case of any technical faults, it shall be corrected only by Head QA with sign & Date. However the same shall be revised in the next revision.
No hand written documents shall be considered as master document.
All master copies shall be kept in Quality Assurance Department under lock and key.
User shall prepare documents or make data entry in records by considering following points:
Be sensitive to GMP compliance.
Record activity immediately but correctly.
Check entry of records for accuracy.
Sign and date immediately on record.
Check if deviation exists.
Don’t destroy record/ evidence in case of deviation or OOS.
Co-operation during investigation.
Checker/ Reviewer shall check/ review the documents by considering following points:
Verify record for adequacy/ accuracy.
Check technique/ skill of user periodically.
Sign and date for review.
Report investigation, deviation, incident etc. promptly.
Advise how to rectify/ correct the error in data entry.
Guide user in technique & skill.
Approver shall approve the document by considering following points:
Verify adequacy/ accuracy/ sensitivity of document.
Verify against guidelines/ regular standards/ SOPs/ Pharmacopoeia.
Sign and date on approval of document.
Guide /Assist in investigation.
Generation of Documents:
All the documents shall be prepared or generate as per their respective SOPs.
Master copies of documents
Master copy shall be an approved original copy of documents and shall be prepared by stamping of “MASTER COPY” stamp in “Green color” (as described below) on each page of the document at right side of top corner position without obscuring any text.
Master copy shall be kept in the custody of QA under lock & key.
Controlled copies of documents
Control copy shall be prepared by photocopy of master copy with stamping of “CONTROLLED COPY” stamp in “blue colour”, QA personnel shall write copy no.with sign& date on each page of the document at bottom right side position without obscuring any text.
Controlled copy is distribution copy of master documents and shall be distributed to users which are mentioned on distribution column of individual SOP for their intended use.
Copy no. of document shall be written in following manner: Department no. /Nos. of copies send to departments, for department no. refer to annexure II of SOP on SOP, e.g. for QA controlled copy, copy no. shall be 01/1, in which 01 represents the department no. as per annexure II of SOP on SOP and 1 represents that only one copy of SOP shall be issued to QA.
Uncontrolled copies of documents
Uncontrolled copy shall be prepared by photocopy of master copy with stamping (as described below) of “UNCONTROLLED COPY” in “red colour” and signed / dated by QA on each page of the document at center on the text matter.
Uncontrolled copy shall be distributed on need as a reference copy for external regulators and concerns.
Issuance of uncontrolled shall be maintained as per annexure I. Retrieval of uncontrolled copy shall not be done.
Issuance & Control of Documents
The drafts of all the controlled documents once finalized after drafting by initiator department and review by QA department shall be finally take print out at Documentation Cell of Quality Assurance. Master copies and controlled copies of these documents shall be prepared as per point no. 6.12 & 6.13.
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. Biennial review shall be undertaken as per SOP on ‘Document and Data Control’ (SOP/QA-017) however change in any shall be undertaken through SOP titled ‘Change Control’ (SOP/QA-016).
All the Calibration data of equipment / instruments shall be kept / maintained by the QA department e.g. QA shall maintained all the data of calibration for thermometers, gauges, PLCs, Motors, Pumps etc. QC shall maintain all the Calibration data of its instruments such as HPLC, Autotitrator, Spectrophotometer, Balance etc.
All the data maintained in laboratory software / production PLCs shall be password protected.
A printed hard copy of analytical & processing data, duly signed by operator shall be preserved along with the respective documents e.g. Chromatograms, PLC report and electronics print outs (if any).
All data shall be executed by doer, checked by supervisor or above and verified by QA (if applicable).
Backup data shall be taken on the compact discs or space access given by IT personnel by time to time.
Electronically generated data like PLC printouts shall not be modified / changed without authorization from Head QA.
All rubber stamps shall be kept under Lock and Key, along with updated list of stamps as per annexure number VIII.
Issuance of all the controlled document govern by QA documentation cell.
Issuance of formats and BMRs shall be as described in their respective SOPs.
For issuance of any type of controlled document, user shall fill the issuance form as per annexure II. The issuance form shall be maintained by QA documentation personnel.
Review and/or Revision of the Documents
All the controlled documents shall be reviewed within one months before and after the ‘Review Date’ assigned on the concerned document.
Revision procedure of documents shall be of two type:
Routine or periodic revision
Provisional or conditional revision
Routine or periodic revision: Revision of document as per assigned review period of respective documents.
During this review, no change required in respective document then such type or revision shall be initiated by “document review form” as per annexure III.
During this review, if any changes required in respective document, then such type or revision shall be initiated by“Change control form” as given in SOP on change control.
Provisional or conditional revision: Revision of documents before assigned review period of respective document.
If need of any change observed in respective control document before assigned review period shall be initiated by only “change control form” as given in SOP on change control.
All the document shall be revised through above described revision procedure (point no. 6.16.2) and in both of case revision no. shall be change.
All the document shall be reviewed by document cell of QA in following manner:
Documentation Cell of QA shall intimate the initiator department to initiate review process as described in point 6.16.2.
Initiator department shall undertake review of the concerned document and shall put its comments.
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 final comment from the concerned department, QA shall dispose the review process.
(Also refer ‘Flow chart-Document Review and Revision Process’ attached as Annexure-IV for guidance)
Quality Assurance shall assess the proposed changes. If proposed changes are acceptable to QA, then QA shall approved the draft copy of respective document.
QA shall forward the approved draft copy to initiator department to prepare a final soft copy of document.
By incorporating all comments on soft copy, initiator shall forward it to QA. Initiator shall ensure its availability in QA and delete the same from his/her computer and E-mail.
QA shall take out the final print out.
Revised copy of document shall be signed by concerned persons,approved by Q.A. Head.
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 in Annexure-V.
Additional controlled and / or uncontrolled copies of the documents, if required, shall be requested through a form titled ‘Requisition for Additional copy’ as described in Annexure-VI. 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.
Archiving of Documents
Arrangement of all the documents shall be with respective department wise that can be identity and easily traceable.
All the batch records received should be reviewed and then store in designated area according to the Batch No.
The master copy of superseded document shall be retained by the Q.A. and stamped (as described below) as “OBSOLETE” in center of document on every page. A list of obsolete documents shall be prepared as per annexure IV.
- Retention of documents
- Records, superseded documents shall be preserved and retained for the period as described in table below:
|S.No.||Type of Document||Retention Period||Method of Destruction|
|1||Cleaning and maintenance documents||After one year of product expiry||Shredding|
|2||Calibration record||3 years||Shredding|
|3||Packaging material record||After one year of product expiry||Shredding|
|4||Batch Manufacturing record||After one year of product expiry||Shredding|
|5||Qualification record||Permanent||Not to be destroyed|
|6||Validation record||Permanent||Not to be destroyed|
|7||Cleaning Validation record||Permanent||Not to be destroyed|
|8||Water system Validation record||Permanent||Not to be destroyed|
|9||Media fill record||Permanent||Not to be destroyed|
|10||Method Validation record||Permanent||Not to be destroyed|
|11||Validation master plan||Permanent||Not to be destroyed|
|12||Site Master File||Permanent||Not to be destroyed|
|13||Master formula record||Permanent||Not to be destroyed|
|14||Vendor audit report||Permanent||Not to be destroyed|
|15||Department manuals||Permanent||Not to be destroyed|
|16||Standard operating procedures||10 year||Not to be destroyed|
|17||Training record||1 Year after resignation of employee||Shredding|
|18||Internal audit record||5 years||Shredding|
|19||Medical records||1 Year after resignation of employee||Shredding|
|20||Controlled copies of Master Documents||Destruction on retrieval||Destruction on retrieved|
|21||Stability Data||Permanent||Not to be destroyed|
|23||Specification, STP, GTPs||5 years||Shredding|
|24||Facility layouts||Permanent||Not to be destroyed|
|25||Filled formats & records||5 years||Shredding|
Note: The retention period shall starts after superseded of documents.
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 department wise list of records as indicated in Annexure-VII.
Each concerned department shall co-ordinate Documentation Cell of QA in maintaining the reference documents like machine manuals, protocols etc.
Documentation Cell of QA or his / her designee shall prepare a matrix (refer specimen attached as Annexure-IX) of all the quality documents and records indicating their various features.
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 Annexure V- Document Distribution and Retrieval Record.
Master copies of all the superseded documents 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 as mentioned in 6.19.1 from the date of obsolescence of the document. After completion of retention period obsolete master copies shall be destroyed by documentation cell 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’ (Annexure-X).
Handling of External Origin Documents
External origin documents such as pharmacopeias, books, reference guideline etc. shall be issued, retrieved and controlled by QA.
Issuance record of these document shall be maintained by QA.
In case new versions of these documents shall be published then QA shall procured these new versions of documents.
QA personnel shall be retrieved the old version of these documents, stamp the control copy on new versions of these documents and issued the control copy of these documents to the relevant department.
Forms and Records
Issuance record of uncontrolled copies – Annexure-I
Issuance record of controlled documents – Annexure-II
Document Review Form – Annexure-III
List of obsolete documents – Annexure-IV
Document Distribution and Retrieval Record – Annexure-V
Requisition for Additional Copy- Annexure-VI
List of all documents Department-wise – Annexure-VII
List of stamps – Annexure-VIII
Document Matrix-Document and Data Control (specimen) – Annexure-IX
Documents/ Data Destruction Record – Annexure-X
Master copy- Quality Assurance
Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering, & Human Resource Development
Reason for Revision
Issuance Record of Uncontrolled Copies
|S. No.||Date of Issuance||Name of Document||Issued to||Issued by||Remarks|
Issuance Record of Controlled Documents
|S. No.||Date of Issuance||Name of Controlled Document||Issued to||Issued by||Proposed retrieval Date||Retrieved by/on||Remarks|
Document Review Form
|From: Quality Assurance Department Location:
To : ………………………< name of initiator department>
|DOCUMENT DETAILS (to be filled by Quality Assurance)|
|Type of Document: (mark tick)
Standard Operating Procedure (SOP)
Batch Manufacturing Record (BMR)
Standard Test Procedure (STP)
General Test Procedure (GTP)
Protocol/ Qualification Document
Due Date of Review:
Current Effective Date or Issue Date:
|Date………….. Signature (Head-QA)…………….|
|COMMENTS BY THE INITIATOR DEPARTMENT (Use continuation sheet if space is insufficient)|
|Does the document need change? (Yes/No)……………..
Reviewed by (Sign and Name of the reviewer) :…………………
Reviewed on: ………………….
Dept Head: Sign/ date………………………
|DISPOSITION BY QUALITY ASSURANCE (Use continuation sheet if space is insufficient)|
|Does this document need Change Control for ‘change’ in the document? Yes No NA
Intimation sent to Initiator Department for raising Change Control on: ………./………../………
List of Obsolete Documents
|Sr. No.||Date||Name of the Document||Document No.||Signature/ Date|
Document Matrix – Document and Data Control Matrix
|Sr. No.||Type of Document||Relevant Reference SOP for Preparation and Numbering (Title and Number)||Initiator Department||Review Period||Approval||Location in Documentation Cell|
Document Distribution and Retrieval Record
Title: Doc. No.: Location:
|*Change Control No.||Distribution Record||Retrieval Record|
|Controlled Copy No.||Received by||Distributed by||Retrieval From||Destroyed by|
Requisition for Additional Copy
Date of Requisition : Location:
|Department Name Signature Designation|
|From : …………… …………… …………… ……………|
To : Quality Assurance
Additional Copies required: Controlled Copy Uncontrolled Copy
Doc. No. :
Reason for additional Copy
No. of Copies required :
Remarks by QA, if any :
Permitted Not Permitted
Manager- Quality Assurance
(Signature / Date)
List of all Documents Department Wise
|S. No.||Name of Document||Document No.||Effective Date||Review Period||Remarks|
List of Stamps
Content for List of Stamps
- S. No.
- No. of Stamps
Documents/ Data Destruction Record
Content of Documents/ Data Destruction Record
- Sr. No.
- Document Type
- Reason for Destruction
- Approved By ( QA Head)
- Destruction on