Good Data and Record Management Practices (SOP for SOPs)

Establishing Standard Operating Procedures Good Data and Record Management Practices (SOP for SOPs) also known as Good Documentation Practices (GDocP), is crucial in maintaining a high standard of data and record management within an organization. The following is a template outline for an SOP for SOPs, emphasizing good data and record management practices.


  • All the Quality Management System and Good Manufacturing Practices (GMP) documents are prepared, properly reviewed and approved by appropriate authorities prior to issue or available at the appropriate locations.
  • All Quality System records related to Quality Management System and GMP are properly identified, filed, indexed, stored, retained and disposed of. Distribution / Circulation/Retrieval Implementation Control.


  • This procedure applies to all the documentation and records related to Quality Management System (QMS) and GMP. EMS / EHS SOPs.
  • This document complies with WHO and PNAC (Pakistan National Accreditation Council) ISO/IEC 23025:2023(E) standard.


Roles Responsibilities
Strategic Officer
  • Issuance and Retrieval of all Documents.
  • Archiving of superseded versions.
  • To review of formation as per SOP.
  • To assign control numbers of concerned departments.
  • Maintenance of records for all original documents in hard/soft form.
  • Review the training record of SOPs
  • To ensure that all documents are being issue and retrieve as per SOP.
Concerned Department Officer/Manager
  • Preparation of documents as per existing procedure,
  • To include sufficient detail that the process or procedure can be followed by another person when needed.
  • Responsible for the creation, revision, deletion, and review of documents affecting their work areas.
Concerned Department Manager/Representative
  • To check and review the SOP. Prior to its use and ensure implementation of this SOP.
  • To ensure that all routine operations and activities in their area are documented by SOPs.
  • Custodian and responsible for maintaining circulated documents and the Master List of records of their departments.
QA Manager
  • To approved & authorize the SOP.
  • To ensure implementation of this SOP
  • To ensure the Compliance of procedure/Process as per SOPs.


Good Data and Record Management Practices (SOP for SOPs)

Guideline for writing SOP

  1. Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing.
  2. Documents should accurately reflect the current methods used within the plant and within the department to ensure that premises, equipment, and processes comply with GMP requirements.
  3. Responsibility for each function should be clearly defined.
  4. Documents should be approved, signed and dated by the appropriate responsible persons. author, reviewer, Approver and Authorizer must be trained on relevant policies.
  5. Where applicable, equipment, time format ( shall be mentioned in AM and PM), frequency, documentation, physical parameters, control and cross reference should be clearly specified
  6. If abbreviations are used then glossary should be given.
  7. HSE aspects and international guidelines should also be considered where applicable.
  8. Effective date should be allotted after training of relevant standard operating procedure it should be within 7 days after issuance.
  9. No document should be changed without authorization and approval.
  10. Documents should have unambiguous contents: the title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.
  11. Where documents require the entry of data, these entries should be clear, legible and indelible. Enough space should be provided for such entries. All work performed is recorded legibly. Work is recorded in such a manner that another individual, competent in the same field, may repeat the work described solely from the description written without additional explanation.
  12. Entries contain the date, initials of person performing the work, signed and dated.
  13. Entries are made in ink. No erases are made. Blank space will be indicated with a line. Lead pencils are not used.
  14. Corrections will be made by drawing a single line through the incorrect entry, enter the correct information, initial and date the change.
  15. Data may be recorded electronically. If documentation is handled electronically, only authorized persons should be able to enter or modify the data in the computer system and there should be a record of changes and deletions. Access should be restricted by passwords or other means and the entry of critical data should be independently checked. It is particularly important that during the period of retention, the data is readily available.
  16. Electronic record and data files are backed up on a regular basis to safeguard against the loss of information due to equipment malfunction or human error.
  17. Data will be backed up on daily, weekly, monthly and annual basis.
  18. External surfaces of disk and diskettes CDs or DVDs are labeled to facilitate accurate filing and retrieval of electronic records. Examples of information may be included on the label are:
  19. Subject or functional title which identifies the information.
  20. Inclusive dates of information contained on the diskettes, CDs or DVDs, and identification of the software program used to access the information.
  21. QA and IT department will retain HPLC backup in hard drive.

SOP Layout Design\Format

  1. Header of page
  2. Department Name
  3. SOP Title
  4. Issue Date: Issue date is the Authorized date of SOP and must be mentioned in DD-MM-YYYY
  5. Effective Date: Effective date is the training date of relevant SOP and must be mentioned in DD-MM-YYYY
  6. Review Date: two years from the month of preparation of SOP or before three years if changes necessitated.
  7. Supersedes: Revision number of same original SOP that is effective till date. Original SOP should be submitted to Quality Assurance Manager and Copies to list attached at the end of SOP.
  8. Signature Lines along with name, date and designation (Prepared by, Reviewed by, Approved by, Authorized by) in blue ink.
  9. There should be a statement in a text box on header of SOP where the text is: “All the SOPs shall be treated confidential and shall not be shown to un-authorized persons”.
  10. No two signatures on a signal document can be made by same person. (Unless justified).

Sop Number Allocation

  1. Each SOP will have a specific number. The number is assigned in a following manner;
  2. Department Code
  3. Section Coding
  4. Subject:
Abbreviation (coding) alphabets can be extended to four. Subject will include the abbreviation regarding name of SOP in order to specify name. Subject abbreviation will be given by writer of SOP.
Numbering sequence
Depart. Code Section Code Subject (SOP Title for example) Coding For Example Number Example 
Quality Assurance QA Compliance COM Handling and reporting of deviations HRD QA-COM-HRD-01
Validation V Installation Qualification & Operational Qualification IQOQ QA-V-IQOQ-01
General (Applicable to all or specific departments/processes/equipment/premises) G In process Control IPC QA-G-IPC-01
Work Instruction WI Operation of DT Apparatus NA QA-WI-001
Quality Control QC General (Applicable to all or specific processes/Equipment/premises) G Procedure for cleaning of Glass wares COG QC-G-COG-01
Internal factory specifications & Testing method(Packing Material)(Finished Goods) TM Packing/FG PMFG QC-TM-PM-001QC-TM-FG-001
Internal factory specifications & Testing method (Raw Material API) Raw Material Non  API) TM Active Pharmaceutical Ingredient APIIN QC-TM-API-001QC-TM-IN-001
Micro Laboratory MIC General (Applicable to all or specific processes/Equipment/premises) G Media Preparation MP MIC-G-MP-01
Product quality monitoring PM Microbial limit testing of raw materials and finished products MLT MIC-PM-MLT-01
Production PR Tablet TAB Operation of coating machine OCM PR-TAB-OCM-01
Suspension SUS Cleaning of suspension filling line CSF PR-SUS-CSF-01
Capsule CAP Cleaning of Capsule Polisher CCP PR-CAP-CCP-01
Injectable(Liquid Injection)(Dry Injection) LIDI Vial filling machine VFM PR-LI-VFM-01PR-DI-VFM-01
Syrup section SYP Filling Machine FM PR-SYP-FM-001
General (Applicable to all or specific processes/Equipment/premises G Cleaning of bins CB PR-G-CB-01
Work Instructions WI Vial Filing Machine NA PR-WI-001
Warehouse WH Raw Material Warehouse RM Handling of Rejected Raw Materials HRRM WH-RM-HRRM-01
Packaging Material Warehouse PM Issuance of Packaging Materials IPM WH-PM-IPM-01
Finished Good Warehouse FG Receiving Handling and Dispatch of Finished Goods RDFG WH-FG-RDFG-01
GENERAL (Applicable to all or specific processes/Equipment/premises) G Housekeeping of Stores HS WH-G-HS-01
Human Resource & Admin HR&A ADMIN ADM Uniform Washing UW HR&A-ADM-UW-01
Human Resource HR Employee Hiring EH HR&A-HR-EH-01
General (Applicable to all or specific processes/Equipment/premises) G Security SC HR&A-G-SC-01
Information & Technology IT General (Applicable to all or specific processes/Equipment/premises) G Procedure for Password protection PP IT-G-PP-01
Engineering ENG General (Applicable to all or specific processes/Equipment/premises) G Welding cutting and grinding WCG ENG-G-WCG-001
Health safety & Environment HSE Health and safety measures HSM ENG-HSE-HSM-001
Electrical ELC Use of Portable electrical equipment PEE ENG-ELC-PEE-001
Mechanical MEC Preventive maintenance of roller compactor PMRC ENG-MEC-PMRC-001
Instrumentation INS Calibration Management CM ENG-INS-CM-001
Heating, Ventilating, and Air Conditioning HVAC Preventive Maintenance of air handling Unit PMAU ENG-HVAC-PMAU-01
Regulatory Affairs RA No applicable Not applicable Application of new products ANP RA-ANP-001
Business development BD International INT BD-INT-G -001
Local LCL BD-LCL-G -001
Supply Chain SC Planning PL Issuance of MO IMO SC-PL-IMO-001
Procurement PRO General item purchasing GIP SC-PRO-GIP-001
R& D RD General G Product Development PD RD-G-PD-001
RD New product development TM Product Name RD-TM-API-001

All department of Healthcare will be use same numbering logic with the code of healthcare example below mentioned
HC-WH-RM-HRRM-001, Decoding. HC = Healthcare, WH = Warehouse , RM = Raw material, HRRM = Handling of Rejected Raw Materials and 001 = serial no.

Allocation of Format number

Department Coding Section Coding Number Example
Quality Assurance QA Not Applicable QA-F-001
Quality Control QC Not Applicable QC-F-001
Micro Laboratory QC Not Applicable MIC-F-001
Production PR Not Applicable PR-F-001
Warehouse WH Not Applicable WH-F-001
HR & Admin HR Not Applicable HR-F-001
Health safety & Environment HSE Not Applicable HSE-F-001
Information & Technology IT Not Applicable IT-F-001
Engineering ENG Not Applicable ENG-F-001
Regulatory Affairs RA Not Applicable RA-F-001
Business development BD Not Applicable BD-F-001
Supply chain SC Not Applicable SC-F-001
R&D RD Not Applicable RD-F-001

Format information block will be located on top right corner of all forms and approval block will be in footer of each page.

Prepared by: Name Checked by: Name Approved by: Name
Sign & Date Sign & Date Sign & Date
Designation Designation Designation

Heading, Subheading, Points and Sub points Sequence Numbering should be done in the following manner.

  1. Header and footer Detailing
  2. SOP number and Nova Med logo should be given within header
  3. On every page header should be repeated.
  4. Page number within footer as follows (e.g. page 1 of page 10).

Document Approval Block

Note: only QMS and HR SOPs will be authorized by CEO.

SOP Contents

  1. Main Contents should be as below.
  2. Table of Contents (not needed if SOP is three pages or less)
  4. SCOPE

Font size and format is explained as under:

Description Font size Font Font Style Case
Company and  department Title in Header 12 Times New Roman Bold Sentence
SOP Title in Header 12 Times New Roman Bold Sentence
Signature Lines along with name, date and designation in Header 11 Times New Roman Bold Sentence
Confidentiality statement in Header 9 Times New Roman Bold Sentence
Headings 14 Times New Roman Bold Upper
Sub Headings 12 Times New Roman Bold Underline Sentence
Text 11 Times New Roman Regular Sentence
Highlighting Text 11 Times New Roman Bold Italic Sentence

Page Set UP:

Paper Size A4
Orientation Portrait (However Landscape may be used)
Margins Customize (Top and Bottom 0.70 Inch) (Left and Right 0.63 Inch)
Header Same for all pages
Footer Same for all pages
Line spacing 1.15
Heading spacing before and after 6pt

Preparation and Review of Draft SOP

  1. The draft SOP must be circulated electronically for review to user department and all related persons.
  2. The SOP author will give a time limit (Maximum two weeks) for checking a draft SOP.

SOP indexing:

SOPs index record will be maintained as per form no.QA-F-003 SOP indices will be updated quarterly, however if any SOP revised before the defined frequency then incorporate manually and update as per frequency.

Distribution of documents

Master Copy
The master copy (Original) of all SOPs will be kept and maintained within the Quality Assurance department.
SOPs related to Quality functions will be distributed as circulation list.
Photocopies of SOPs will be distributed to all concerned as defined in the respective SOP. The QA department will allocate a unique serial with a stamp in Blue ink of “NOT VALID IF PHOTOCOPIED” on all pages of SOP. Record will be maintained on format QA-F-001 “Document Issuance record”. Any extra copy required will be issued on request through email by departmental manager.

Revising SOPs

If the SOP does not accurately describe the procedure, then the SOP must be revised. Any change in the procedure must be incorporated into the SOP. However, prior to any change to the SOP, management must be advised of, and approve, the change.
“Change history” of SOP must consist of changes made in current and superseded revision (if applicable).
Finalized SOPs, containing typographical errors, printing errors, e.g., wrong page numbers or misaligned sentences) or any errors that do not affect the scope of the procedure should be corrected immediately and reprinted. These types of errors do not require full SOP revision; thus a revision number will not be generated.

Training on SOP

Effective Date of every SOP will be given after training of relevant SOP. The training procedure will be in accordance with Personnel Training SOP.

Record Management

Access and location of SOPs

Appropriate SOPs will be placed in binders to be found in a designated spot in each work area, e.g., laboratory, equipment rooms, and shall be available to staff and managers. Removal of an individual SOP requires completion of the sign-out located on the insider of the binder. The binder must not be removed from its designated spot by anyone other than the Quality Assurance Manager. It is the responsibility of the QA assistant to check updated binder as individual SOPs are revised. The staff is required to read any revised SOP within 7 working days of issuance if the SOP is applicable to their work. Reading of the updated SOP requires signature on the SOP review sheet.

Superseded SOPs and Obsolete SOPs

Handling and retention of superseded and obsolete SOPs should be expiry plus one year As per SOP. “Document Retention, Retrieval and Destruction”. A stamp will be allocated on superseded versions of documents.

Note: It is the responsibility of the QA department that all superseded / obsolete controlled copies are retained and destroyed respectively.

Retrieval of superseded documents.

All previous documents will be retrieve at the time of circulation of current versions on form no. QA-F-0002


  1. Document number (QA-G-GRM-001) specifies that:
  2. Department is Quality assurance (QA)
  3. This SOP is applicable to all standard operating procedures of egg pharmaceuticals (Pvt.) Ltd.
  4.  “GRM” represents the name of SOP i.e. Good Data record management practices SOP for SOPs.
  5. Numbering sequence is 001.


June-2022 QA-Gen-0 SOP format changed as per SOP for SOPs.
June-2023 QA-G-GRM-001 Revision No.06 Heading 4 Numbering sequence Work instructions numbering incorporated.
Heading 9 Distribution list updated
Removed CEO Sign and routine revision as per Sop number QA-G-GRM-001


  • Document Issuance form QA-F-001
  • Document retrieval form QA-F-002
  • Index QA-F-003
  • Document Change form QA-F-004


  • Guidance for the Preparation of Standard Operating Procedures. U.S. EPA. Current Version.
  • WHO_TRS_996_Annex 5 (Guidance on good data and record management practices).
  • ISO/IEC 17025:2017(E) 8.2Management system documentation.


  1. Production Pharma
  2. Production Healthcare
  3. Quality Control
  4. Warehouse Pharma
  5. Warehouse Healthcare
  6. Regulatory Affairs
  7. Business development (Local)
  8. Business development (International)
  9. R&D
  10. IT

HR & Admin

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