Procedure For Document Storage Period

Procedure For Document Storage Period

STANDARD OPERATING PROCEDURE
Title :   Procedure For Document Storage Period
  • OBJECTIVE
  •   To define the procedure for Document Storage Period.
  • SCOPE
    • This procedure is applicable to Quality Assurance Department.
  • RESPONSIBILITY
    • Officer-Quality Assurance
    • Executive-Quality Assurance
  • ACCOUNTABILITY
    • Manager-Quality Assurance
  • PROCEDURE
    • The Batch Manufacturing Records and Batch Packing Records along with all the related documents shall be stored in the archive of Quality Assurance department for a period of one year from the expiry date.
    • The following Master Records shall be archived in Quality Assurance as Permanent record.
      • Master Formula Records (MFRs) for Drug product.
      • Site Master Files & Validation Master files (SMF’s & VMF’s).
      • External Agency Audit records/reports.
      • Manufacturing License Documents.
      • Drug Master Files (DMF’s) / Dossiers.
      • Standard Operating Procedures (SOPs).
      • Standard Testing Procedures (STPs).
      • General Testing Procedures (GTPs).
      • Validation Protocols (Cleaning Validation, Analytical Method Validation, Process Validation, Utility Validation, Equipment Qualification Protocols, etc.).
      • Master Batch Manufacturing Records & Batch Packing Records (BMRs & BPRs).
    • All Warehouse Records viz, Stock cards, GMP Records, Dispatch Records, Central excise Documents, etc., shall be preserved for a period of five years in archives of Ware house.
    • All Quality Control records viz, Analytical Reports, Analytical Method Development Reports, Instrument Calibration Records, Reagent / Standard Preparation Records, RM, PM In-process / Finished Product Registers, Stability Test Reports shall be preserved for a period of five years in archives of Quality Control department.
    • All Engineering Records viz, Gauge Calibration Records, Equipment / Utility Qualification records, Equipment / Machine Logs, Filter Cleaning Records, Break Down /Preventive Maintenance records, etc. shall be preserved for period of five years in archives of Engineering department.
    • The records of Personnel department viz, Administration record, Medical Checkup records shall be preserved permanently in archives of personnel department. Other records viz., Area Cleaning Records, Disinfectant/detergent usage records, Pest control Records, Cleaning of Linen / Slippers/Shoes records, Scrap Collection records, etc. are preserved for period of five years in archives of Personnel department.
    • All Production Records viz., Equipment Operation and Cleaning log, Area Monitoring records, Balance Calibration Records, Batch Manufacturing & Batch Packing Registers, Tools/ spares/Dies records etc. shall be preserved for period of five years in archives of Production department.
    • The GMP Records viz., Self Inspection Records, Vendor Documents, Deviation Records, Non-Conformance Records, Out of Specifications, Market Complaints Records, Product Recall Records, Signature Log, Validation Reports (Process, Cleaning, Equipment /Utilities), other ISO Quality System Records viz., MRM file, IQA Schedule, etc., shall be preserved for a period of five years in archives in Quality Assurance Department.
    • GMP records viz., Training Records are archived till the employee is in service.
    • Change Control Records, ISO Quality System Manual and Quality System Procedure shall be preserved permanently in archives of Quality Assurance Department.
    • Records related to Purchase, Marketing, Projects shall be preserved for a period of 3 Years in the archives of Respective Departments.
    • Documents shall be stored in a separate room under lock and key.
    • Access to the stored documents shall be restricted and controlled by the concerned department head.
    • In-case of all official Master Records and Batch Records which are stored in the archives of Quality Assurance, the access shall be made only after due authorizations from Manager-Quality Assurance.
    • Destruction of documents after its expiry of storage period shall be done after obtaining permission from Manager – QA and such records shall be maintained as per format no.1.
  • ABBREVIATIONS
    • IQA –  Internal Quality Audit
    • MRM –  Management Representative Meeting
  • ATTACHMENT
Sr. No. Title  Format No.
1 Document destruction approval form
  •  DISTRIBUTION LIST
Sr. No. Copy No. Department
Quality Assurance
Quality Control
Quality Control – Microbiology
Production – Tablet Section 
Engineering & Utility
Personnel & Administration
Warehouse

 

ATTACHMENT-I

DOCUMENT DESTRUCTION APPROVAL FORM

Date: _____________

From To Quality Assurance

Kindly verify the following documents, which are due for destruction.

Sr. No. Title Storage Period Remarks
From To
Signature/Date : ________________            Approved by/on : _____________________

                               (Department-Executive)                                                      (Department-Head)

Quality Assurance verification & Approval

Documents Verified by            On
Documents certified for destruction by Manager – QA On
Destruction Done by On
Destruction Witnessed by On
Destruction Mode

PERFORMANCE QUALIFICATION OF AUTO COATER

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