Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes. The purpose is to ensure that everyone uses the correct and current document processes and specifications.
Documents and Data Control
1.0 Objective
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- To lay down a procedure for control of documents and documented data.
2.0 Scope
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- This SOP is applicable for the control/management of documents and documented data at the pharmaceutical drug manufacturing plant.
3.0 Responsibility
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- Authorized QA person shall be responsible for issuance and retrieval of the SOP’s, formats, Protocols, etc.
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- All HODs shall be responsible to follow this SOP for maintaining control on all documents and documented data or records.
4.0 Procedure for Documents and Data Management
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Documents and Data Control:
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- Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes.
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- The purpose is to ensure that everyone uses the correct and current document processes and specifications.
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Control of Documents:
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- After preparation, the original signed documents shall be submitted on A4 size bond paper to the QA department to control & storage.
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- The originally signed copies of all documents shall be stamped as ‘MASTER COPY’ stamp using Red ink as per the below image, on the top right corner of each & every page. It is referred to as MASTER COPY.
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- For the preparation of controlled copies of the master copy, authorized QA personnel shall arrange photocopies of the master copy on plain A4 size paper, using one side of the plain paper.
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- Each page of the photocopy of the master copy shall be stamped as ‘CONTROLLED COPY’ using blue ink, on the top right corner below the master stamp of each page (rectangular space) with Sign/Date of the authorized QA person on each page.
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- A record of controlled copies shall be maintained.
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- These copies shall be used for filling data or as reference documents.
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- While issuing an uncontrolled copy of the documents and data, the photocopy of the master copy shall be stamped as ‘UNCONTROLLED COPY’ using blue ink, on the right-hand bottom corner of each page with the sign and date of the authorized QA person.
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‘UNCONTROLLED COPY’ shall not be required to be retrieved.
- The Master copy stamp, controlled copy stamp, obsolete copy stamp, uncontrolled copy stamp, and all other related stamps shall be under the control of the QA documentation cell/ Authorized QA person.
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- Only QA shall retain a computer copy of SOPs with Annexure(s) of all departments and other master documents.
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- QA department shall store the computer copies (SOP) in department-wise folders.
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- In these folders create the folder named ‘Master SOPs’. The ‘Master SOPs’ folder shall store respective SOPs and their annexure along with the SOP index.
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- Only the current version of the SOP shall be maintained in the soft copy folder.
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- Data back up shall be taken at least once in a six month by IT department.
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- The computer system in which all documents preserved in soft copy form shall be password protected and password shall be available to the user, section Head, and QA head only.
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Obsolete Documents and Data:
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- Obsolete documents are those which are no longer required, replaced.
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- These documents may be identified as part of the review process and shall be removed from the master documents and appropriately archived to prevent unintended use.
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- Archived documents must be retained and accessible for system evaluation and legal purposes.
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- The “OBSOLETE COPY” as per the below image of the old version of a master copy shall be stamped with red ink on the right-hand bottom corner of each & every page on the text with the sign and date of the authorized QA person.
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Requisition/Issuance/Retrieval of Logbooks (Documents and Data Control):
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- The user department shall send the approved requisition, before the implementation of logbook/formats/protocols to the QA department as per Annexure-I at least one week before.
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- The authorized QA personnel shall issue the logbook as per approved requisition and issuance & retrieval record shall be maintained on Annexure-I.
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- Annexure-II shall be affixed on the first page of the equipment/instrument logbook.
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- Whenever required opening balance or other entry shall be a transcript from the old logbook and reference of the same logbook shall be written in the current logbook for traceability purposes.
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- All filled logbook shall be retrieved at end of the year except those logbooks which are used to maintain the stock.
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- Logbooks that are used to maintain the stock same shall be continued till a change in the format or completion of the logbook.
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- If there requirement for a second logbook in the same calendar year same shall be issued after retrieval of the previous logbook and the record shall be maintained in Annexure – I.
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Requisition/Issuance/Retrieval of Formats (Documents and Data Control):
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- The user department shall send the approved requisition as per Annexure-I, one week before the end of the month to the QA Department.
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- The pdf file shall be converted from the word format copy of the Annexure(s) and the same shall be kept in the QA custody.
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- For issuance of format, the authorized QA person shall take the printout of the required annexure from the computer and put the stamp as ‘CONTROLLED COPY’ using blue ink, on the top right corner of each page (rectangular space, if provided).
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- The authorized QA personnel shall sign and date in the stamp and the same shall be issued as per approved requisition and the issuance record shall be maintained on Annexure-I.
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- If there is no retrieval, NA shall be written under the retrieval and remark column.
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- If issued formats are retrieved same shall be recorded in Annexure-I and shall be destroyed by shredding and shall be updated under remark column.
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Requisition/Issuance/Retrieval of Protocols (Documents and Data Control):
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- The user department shall send the approved requisition on Annexure – I, as when required to QA Department.
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- For issuance of protocols, the authorized QA person shall take a photocopy of the respective protocols and put the stamp as ‘CONTROLLED COPY’ using blue ink, on the top right corner of each page (rectangular space, if provided).
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- The authorized QA personnel put sign/Date as space provided on respective annexure and issuance and retrieval record shall be maintained as per the Annexure-I.
- Requisition, Distribution, and Retrieval of the Documents and Data:
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- User department shall provide the approved request to QA for executed documents (Such as Manual, Qualification documents, Executed Batch records, Executed QC data, etc.) whenever required as per Annexure-III.
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- Each department shall submit original documents to QA, the reference documents (like machine manuals, etc.), and literature cross-referred in preparing the documents like SOPs, protocols, etc. The controlled copy of the master documents shall be issued to the user department for reference purposes.
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- The issued and retrieval record shall be maintained as per Annexure-IV.
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- Additional pages of BMR / BPR shall be issued after receipt of approved requisition from production as per Annexure-V.
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- SOPs may require the annexure which is to be updated frequently e.g. list of equipment, list of approved vendors as per SOP.
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- In this case, the annexure shall be updated and controlled, and distributed as per this SOP. While revising such annexure, it is not required to revise the whole SOP unless the objective and scope of the SOP gets changed.
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Review / Revision of the Documents and Data:
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- The SOPs shall be reviewed/ revised follow the direction of SOP Management and all other master documents shall be reviewed within + 30 days of the ‘Review Date’ assigned on the concerned document.
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- The documents on which reviewed dates are not defined like MFR, specification, TDS, protocols shall be reviewed within 2 Years + 30 days and if any discrepancy observed shall be handled as per Annexure – VIII.
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- After the approval of Annexure- VIII, the same shall be rectified.
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Periodic Review of logbook:
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- All the logbooks of equipment/machines log books etc. shall be reviewed monthly and records shall be maintained on Annexure-II.
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Handling of Records
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- Each department shall be responsible to fill all the records relevant to the approved written procedures.
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- The documented data or records shall be forwarded to the QA department at appropriate intervals.
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Issuance of documents to inspection team/Customer
- For Onsite Inspection Team:
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- Request for any record by the inspection team shall be communicated by the cross function audit team to the QA back-up team.
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- The QA back-up team members shall retrieve the correct record, review for adequacy, completeness and relevance, before passing it over to the cross function audit team.
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- Original documents/Controlled documents shall be provided to the inspection team whichever applicable.
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- The cross function audit team members attending to the inspection team shall ensure that the original records / documents are returned back to the respective departments.
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- For Offsite inspection Team/Customer:
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- Photocopies of records/documents for the inspection team shall be stamped with “UNCONTROLLED COPY” and signed with the date by QA.
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- A list of photocopies of all such records/documents handed over to the inspection team shall be available with QA for future reference so as to avoid contradictions/confusion.
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- No original records/documents shall be given as evidence to the offsite Inspection team for attachments to their audit reports.
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Handling of external documents and data:
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- If any external origin document like –
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- Pharmacopoeial document,
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- Reference books or any type of technical document
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- Received at the plant shall be stamped by QA authorized person as per below on the first page and the last page of the document after review and verification of documents.
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Review and approval of calibration certificates, validation certificate, and reports:
- All the calibration data of equipment/instrument like
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- Data of calibration for thermometers, gauges, PLCs, motors, pumps,
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- Validation certificate, and reports, etc received from outside party shall be received and reviewed by the engineering department
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- Kept/maintained by the QA departments and this certificate shall be stamped with sign and date.
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- Wherever required, a reference copy of the Master calibration certificate shall be issued to the user function as per their requirement.
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- The analytical reports shall be received, reviewed and these reports shall be stamped on suitable space on each and every page of calibration certificate with sign and date by authorized QC person and record maintained in the relevant documents.
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Issuance of records for reference
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- In case supporting documents /records attached with any master documents, change control deviation, CAPA, etc that time photocopy of the master documents stamp as “REFERENCE COPY” using red ink on the right-hand bottom corner of each page with sign and date of authorized QA person.
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Storage and Destruction of Documents and Records / Data:
- All the documents/data must be kept under lock and key in the control of Quality Assurance and record shall be maintained.
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- Authorized QA Person shall prepare a list of records in duplicate and paste one copy on the box & the second in the file which is placed in the record room.
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- Place the box on the rack and write the rack no. on the box and on the second copy that is filed.
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- The storage arrangements must make reasonable provisions to prevent loss of or damage to the documents.
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- The risk factors to be considered when assessing the storage arrangements include fire, water, environmental conditions, insects, rodents, theft, Accidental destruction, incorrect filing, easy retrieval, and failure to return from the issue department.
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- The retention period of the documents/records shall be handled as per Annexure-VII.
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- For Regulatory Market,
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- The specific requirements apply to batch documentation which must be kept for one year after the expiry of the batch to which it relates or at least five years after certification of the batch by the Qualified Person, whichever is the longer.
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- The batch documentation must be kept for at least five years after the completion of formal discontinuation of the last clinical trial in which the batch was used.
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- Destroy the documents by cutting them into small pieces in presence of Head QA /Designee.
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- The record of destruction shall be maintained by QA as per the Annexure – VI.
5.0 Annexure – Documents and Data Control
Annexure-I – Requisition/Issuance/Retrieval for Log Books/Formats/Protocols
Department: ………………… Date…………….
| Issuance Record | Retrieval Record | ||||||||||
| S. No. | Title | Format No. | Eq. ID No. /Area | Number of copies of Logbooks/Formats/ Protocols | Issued By (QA) Sign/Date |
Page No. | Received
By Sign/Date |
No.of copies Retrieved | Retrieval By (QA)
Sign/Date |
Remarks
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| From | To | ||||||||||
Requested By (Sign. & Date)
Annexure-II – Review record of Equipment / Instrument Log Book
| Monthly Review: Shall be reviewed in first week of next month. | ||||
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Sr. No. |
Month/Year | Checked By
(User Department) Sign/Date |
Reviewed By (QA) Sign/Date |
Remark |
Annexure-III – Document Issuance and Retrieval Form
| Department | Date | |||||||
| Name of the document required | ||||||||
| Document No. | Revision No. | |||||||
| Number of Copies / Pages / Required | ||||||||
| Details of Document
(Like B. No. / Protocol No./Report No. whichever is applicable) |
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| Reason for Requisition | ||||||||
| Initiated By (User) Sign. & Date | Checked By (User) Sign. & Date | |||||||
| Request Approved / Rejected By QA (Comments if any) | Head QA Sig. & Date | |||||||
| Document Received (User) By | Name | Sign | Date | |||||
| Document Retrieval Details | ||||||||
| Document Submitted (User) By | Name | Sign | Date | |||||
| Document Retrieved By QA | Name | Sign | Date | |||||
Annexure-IV – Distribution and Retrieval Record of Documents
| S. No. | Name of Document | Document No. | Revision No. | Effective Date | No. of Copies | Department | issued By | Received By / ON | Submitted By User | Received By / ON (QA) |
Annexure-V – Format for Issuance of Additional Pages of BMR / BPR
| Department | Date |
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| Type of Document |
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| Product Name | ||||
| Document No. | ||||
| Revision No. | ||||
| Batch No. | B. Size | Mfg. Date | Exp. Date | |
| Page No. | No. of Copies | Reason for Requirement | ||
| Initiated By
Sig. & Date |
Approved By HOD
Sig. & Date |
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| Request Approved / Rejected By QA (Comments if any) | Head QA
Sig. & Date |
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| Request Received By
Sig. & Date |
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| Document Issued By
Sig. & Date |
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| Received By (Production) Sign. & Date | ||||
Annexure VI – Document Destruction Record
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S. No. |
Document Title | Document No. | Batch No./A.R.No. | Destroyed By
Sign/Date |
Remarks |
Annexure-VII – List of Completed Document Retention Period
PRODUCTION
| Name of Document. | Retention Period |
| Batch Production Record(s) of Exhibit Batch and Process Validation. | Perpetual |
| Batch Production record | 5 Years |
| Equipment Logs (usage and cleaning) | 5 Years |
| Equipment/Instrument Calibration Records | 5 Years |
| Record for inspection of tools and punches. | 5 Years |
| Area Cleaning Records | 5 Years |
QUALITY CONTROL
| Name of Document. | Retention Period |
| Finished Product and Stability Record of analysis for Exhibit batch(es). | Perpetual |
| Raw material/packaging material Record of analysis for materials (AR No.) used in Exhibit batch(es). | Perpetual |
| Analytical record(s) related to cleaning validation. | Perpetual |
| Analytical Method Transfer qualification report(s) and related register(s). | Perpetual |
| Raw Material and Packaging Material records | 5 Years |
| Reference standard/Working standard records | 5 Years |
| Volumetric solutions preparation and standardization record | 5 Years |
| Instrument/equipment usage Logs. | 5 Years |
| Control sample records for Raw materials. | 5 Years |
| Calibration records of instruments/Equipment and Glassware. | 5 Years |
| Vendor samples analysis data | 5 Years |
| Microbiology records | 5 Years |
| Analytical Method Validation Protocol(s) and Report(s). | Perpetual |
| Analytical Method Development Report(s). | Perpetual |
| Registers and files related to analytical Method validation and development. | 5 Years |
| Sample inward register | 5 Years |
| Environmental monitoring records | 5 Years |
| Master Validation Plan. | Perpetual |
| Equipment Qualification Protocol(s) | Perpetual |
| HVAC Validation. | Perpetual |
| Water system validation protocol(s) | Perpetual |
| Compressed air validation protocol(s). | Perpetual |
| Cleaning validation protocol(s). | Perpetual |
| Process validation protocols and reports | Perpetual |
QUALITY ASSURANCE
| Name of Document. | Retention Period |
| Stability Protocols of Validation / commercial batch(es). | Perpetual |
| Obsolete and superseded master documents | Perpetual |
| Vendor Qualification files | Perpetual |
| Layout files | Perpetual |
| Stability Protocol(s) | Perpetual |
| Master document Issuance Records. | 5 Years |
| Issue Records of other than master documents | 5 Years |
| Control Sample Record of Finished product | Expiry + 1 Year |
| Change control log and related records | 5 Years |
| Self Inspection Record | 5 Years |
| Out Of Specifications investigation records | 5 Years |
Market complaint record |
Perpetual |
| Annual product quality review report(s) | Perpetual |
| Product recalls documents | Perpetual |
| Deviations log, incident, and related reports | 5 Years |
| Training records | 5 Years from the date of resignation/retirement of the employee |
| Hold Time Study records | Perpetual |
| Employee Specimen Signature Record | 5 Years from the date of resignation/retirement of the employee |
| Product Development documents | Perpetual |
| Stability Protocol(s) for Exhibit batch | Perpetual |
| Technology Transfer documents | Perpetual |
REGULATORY AFFAIRS
| Name of Document. | Retention Period |
| Abbreviated New Drug Application | Perpetual |
| Annual reports, supplements and amendments | Perpetual |
| Site Master File. | Perpetual |
ENGINEERING
| Name of Document. | Retention Period |
| Equipment/Instruments calibration records | 5 Years |
| Filter cleaning log book. | 5 Years |
| Equipment usage and Maintenance log | 5 Years |
| Preventive maintenance/ Breakdown Maintenance records | 5 Years |
WAREHOUSE
| Name of Document. | Retention Period |
| Material inward register(s). | 5 Years |
| Equipment usage and cleaning logbooks. | 5 Years |
| Calibration record of equipment/Instruments. | 5 Years |
| Stock cards | 5 Years |
| Return drug product documents. | 5 Years |
| Environmental monitoring records | 5 Years |
| Calibration records | 5 Years |
Annexure VIII – Review of Documents
Document Name:
Document Number: Revision No.
Reason for Review:
Review Details:
| Sr. No. | Observations | Proposed Action |
Reviewed By (Sign/Date)
Remarks/Comments:………………..……………………………………………………………………
Annexure IX – Logbook for issuance of perforated formats
| Date | Title of Format | Format Number | Page Serial No. | Used for | Issued by
Sign/Date |
Remarks | ||
| Product/Material | Batch No./ARNo. | Other | ||||||
6.0 Reference (S)
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- The Rules Governing Medicinal Products in the European Union: Volume 4, EUGMP Medicinal Products for Human and Veterinary Use. Chapter 4: Documentation.
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- Drugs and Cosmetic Act 1940 Schedule M.
