Procedure For Document Storage Period

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

•  DISTRIBUTION LIST

ATTACHMENT-I

DOCUMENT DESTRUCTION APPROVAL FORM

Date: _____________

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

PERFORMANCE QUALIFICATION OF AUTO COATER