Procedure For Document Storage Period
|STANDARD OPERATING PROCEDURE|
|Title||:||Procedure For Document Storage Period|
- To define the procedure for Document Storage Period.
- This procedure is applicable to Quality Assurance Department.
- Officer-Quality Assurance
- Executive-Quality Assurance
- Manager-Quality Assurance
- 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.
- IQA – Internal Quality Audit
- MRM – Management Representative Meeting
|Sr. No.||Title||Format No.|
|1||Document destruction approval form|
- DISTRIBUTION LIST
|Sr. No.||Copy No.||Department|
|Quality Control – Microbiology|
|Production – Tablet Section|
|Engineering & Utility|
|Personnel & Administration|
DOCUMENT DESTRUCTION APPROVAL FORM
Kindly verify the following documents, which are due for destruction.
|Sr. No.||Title||Storage Period||Remarks|
|Signature/Date : ________________ Approved by/on : _____________________
Quality Assurance verification & Approval
|Documents Verified by||On|
|Documents certified for destruction by Manager – QA||On|
|Destruction Done by||On|
|Destruction Witnessed by||On|