Record Retention and Archival Policy

The retention period for the Documents and Records in which record shall be retained /preserved in a facility according to their archival policy. The followings are the records and their recommended archival period.

Record Retention and Archival Policy  in Pharmaceuticals

1.0    POLICY DOCUMENTS

Sr. No. Document / Record Name

Record Retention Period / Archival Policy

1.1

Quality Policy Organizational Life Cycle

1.2

Site Master File Facility Life Cycle

1.3

Validation Master Plan Up to next revisions or 10 years since obsoleted whichever is longer

1.4

Global Quality Standards Up to 10 years since superseded / Obsoleted

 

Also, visit : Document Management System – SOP

2.0    INSTRUCTION DOCUMENTS

Sr. No.

Document / Record Name

Record Retention Period / Archival Policy

2.1 Standard Operating Procedures (SOPs) Up to 10 years since superseded/obsoleted
2.2 General Procedures (GPs) Up to 7 years since superseded/obsoleted
2.3 Standard Testing Procedures (STPs)
2.4 Specifications
2.5 Master Formula

Formulation Order (FO)

Packing Order(PO)

Manufacturing Instructions (MI)

Packing Instructions(PI)/ MPR

For “In Approval” / “Approved” / “Withdrawn / Rejected” Applications: Product Lifecycle + 2 years
2.6 System Simulation (Media Fill) Protocols Protocol (s) used for Facility Commissioning – Up to Facility Lifecycle.

Protocols used for all other runs – Up to next 2 revisions or 7 years since obsoleted, whichever is longer

2.7

Computer System Validation Protocols

Computer System Life Cycle + 7 years

2.8 Analytical Method Validation (AMV) Protocols For “In Approval” / “ Approved” / “Withdrawn / Rejected” Applications: Product Lifecycle + 2 years

 

2.9 Process Validation (PV) / Process

Performance Qualification (PPQ) / Post-PPQ Protocols

2.10 Analytical Method Transfer (AMT) Protocols
2.11 Product Hold Time Study Protocols
2.12 Analytical Testing Procedures (ATPs) Up to 7 years since superseded/obsoleted
2.13 Cleaning Validation (CV) Protocols For “In Approval” / “ Approved” / “Withdrawn / Rejected” Applications: Product Lifecycle + 2 years
2.14 Transportation/Shipping Qualification Protocols Up to next 2 revisions or up to 7 years since obsoleted, whichever is longer
2.15 Equipment, System & Area Qualification Protocols Equipment / System / Facility Lifecycle (as applicable) + 2 years
2.16 Stability Study Protocols

i.  Registration Batches /  Exhibit Batches.

ii.   Commercial Batches

i.  For “In Approval”/” Approved”/ ”Withdrawn/ Rejected” Applications: Product Lifecycle + 2 years.

ii.  Up to next 2 revisions or up to 10 years since obsoleted, whichever is longer

2.17 Environmental Monitoring Protocols, results, trend reports (Viable and Non-Viable) 5 years from certification of last lot/batch release by Qualified Person or 1 year after the expiration date of the last lot/batch.

 

3.0    RECORDS RETENTION  AND ARCHIVAL POLICY

    • Part 1

Sr. No.

Document Name

Record Retention Period / Archival Policy

3.1 Analytical Method Validation (AMV) Reports and Records For “In Approval” /” Approved” /”Withdrawn /

Rejected” Applications: Product Lifecycle + 2 years.

 

3.2 Process Validation (PV) / Process

Performance Qualification (PPQ) / Post-PPQ Reports and Records

3.3 Analytical Method Transfer (AMT) Reports and Records
3.4 Product Hold Time Study Reports and Records
3.5

 

Technology Transfer Dossier (TTD) and Process-Development Reports  For “In Approval” / ”Approved”/ “Withdrawn” /  ”Rejected Applications”:

Product Lifecycle + 2 years

3.6 Cleaning Validation (CV)  Reports and Records For “In Approval” /” Approved” /”Withdrawn /

Rejected” Applications: Product Lifecycle + 2 years.

3.7 Annual Product Review (APR) Reports
3.8 Product Complaints/Adverse Event Reports
3.9 Product Recall related Documents
3.10 Returned Goods related Documents
    • Part 2

Sr. No

Document / Record Name

Record Retention Period / Archival Policy

3.11 Packaging Material Art Work and Master Specimens Product Lifecycle + 2 years.
3.12 Stability Study Reports (Commercial Batches) Up to 10 years since report sign-off
3.13 Deviations,  Investigations,  ChangeControls (other than a facility-related),  CAPAs,

Incidents, OOS, OOT records – other than those related to Registration

Batches/Exhibit Batches

Up to 7 years since initiation year
3.14 Change Control Records – Facility Related Facility Lifecycle + 2 years
3.15 Log Books / Notebooks / Registers

(related to product manufacturing and testing)

Up to 7 years since last record entry
3.16 Logs / Notebooks / Cards / Registers / Forms

(other than those related to product manufacturing and testing)

Up to 5 years since last record entry
3.17 System Simulation (Media Fill) Records and Reports. Reports of Facility Commissioning Runs – Up to Facility Lifecycle

Reports of all other runs – Up to 7 years since the year of activity

3.18 Computer System Validation Reports Computer System Life Cycle + 7 years
3.19 Equipment/Instrument/System/

Area Qualification Reports and Records

Retain till Equipment / Instrument / System /

Area Lifecycle (as applicable) + 2 years

3.20 Calibration Records Up to 5 years since the activity
3.21 Batch Production Records (of commercial batches) including in-process and

Finished product testing records (worksheets, chromatograms, spectra, printouts, etc.) of Dosage Forms

Batch Expiry + 1 year OR up to 7 years, whichever is longer
3.22 Batch Production Records (of commercial batches) including in-process and

finished product testing records (worksheets, chromatograms, spectra, printouts, etc.) of API  including Intermediates

Batch Expiry + 1 year) OR

up to 7 years after Authorized Person’s

Signature (if applicable), whichever is longer.

For APIs with retest dates, 3 years after the

API batch is completely distributed or 7 years since the last retest date, whichever is longer.

    • Part 3

Sr. No

Document / Record Name

Record Retention Period / Archival Policy

3.23 Registration Batch / Exhibit Batch records including the following:

  1. Manufacturing/Packaging Records (Original)
  2. Analytical Testing Records (Original)
  3. Raw Data for all stability lot studies (Original)
  4. CAPAs / Deviations / OOS /Change Controls, etc. associated with registration
  5. Stability Reports
  6. Any related documents
Product Lifecycle + 2 years
3.24 Transportation/Shipping Qualification Documents / reports Up to 7 years since the year of activity
3.25 Internal Audit Reports /Corporate Audit Reports and Audit Responses Audit Closure + 2 years
3.26 Customer Audits Reports,

Investigations and Audit

Responses were given by Plant / Location

Audit Closure + 2 years
3.27 Regulatory Agency Inspection

Reports, Investigations and

Responses are given to them by Plant / Location

Facility Lifecycle
3.28 Documents and Records gave to

investigators or/auditors at the

time of inspection

Inspection Closure + 3 years
3.29

Drawings/Layouts

Facility Lifecycle

3.30 Mock Recall Related Documents Up to 5 years since the activity
3.31 Vendor list / Vendor Qualification Reports

(RM Vendors /PM Vendors / cGxP Related Contract Service Providers)

Vendor Life Cycle + 2 years
3.32 Vendor Qualification Reports

(Computer Systems)

Vendor Life Cycle + 7 years
3.33 Material Receipt and 

Goods Distribution Records

Up to 7 years since Record Sign-Off
    • Part 4

Sr. No

Document / Record Name

Record Retention Period / Archival Policy
3.34 Product Salvage Records

1) Records for receipt of materials considered salvage

2) Assessment of product quality

3) Records for return to stock

5 years from certification of batch/lot release by Qualified Person or 1 year after the

the expiration date of the salvaged lot/batch, whichever is longer.

3.35 Maintenance Job Cards Up to 5 years since last record entry
3.36 Management Review Reports, QRB Records Up to 4 years since activity year
3.37 Preventive and Breakdown Maintenance Records Up to 7 years since last record entry
3.38 Schedules and Planners

(e.g.Training, Preventive Maintenance, Calibration, etc.)

Year for which Schedule/Planner is relevant + 4 years
3.39 The operation, Cleaning, Sanitization Records of Utility Systems Up to 5 years since activity year
3.40 Chemical and Microbiological Testing Records,

Summary/Trending Data for:

a) Environmental Monitoring

b) Water

c) Compressed Air

d) Nitrogen

e) Pure Steam

Up to 5 years since activity year

 

3.41 Quality / Technical Agreements (TA)

(including those with contract service providers)

Up to 5 Years after the termination of the agreement
3.42 Pest Control Reports Up to 5 years since activity year
3.43 Personnel Qualification Reports and Records Up to 7 years since the year of activity
3.44 Obsolete Computer Programs Based on the strategy given in System Decommissioning/ Retirement Plan
3.45 Computer Decommissioning documentation and

Decommissioning Summary Report

Facility Lifecycle
3.46 All HVAC routine monitoring reports including a downloaded record from data logger / BMS / software Up to 5 years since the year of activity
    • Part 5

Sr. No Document /Record Name

Record Retention Period / Archival Policy

3.47 Document Requests,

Document Distribution,

Retention and Destruction records

Up to 5 years since activity in case of individual records

Up to 5 years since last entry in case a log is maintained for the same.

3.48 Daily Cleaning and Sanitization

(Housekeeping) records

6 months since the month of activity
3.49 Attendance Records Records managed electronically: Permanent retention (not to be destroyed)

Records managed manually: 10 Years

3.50 Daily Work Allotment / Daily Reports 2 months
3.51 Records of post-analysis sample disposal 2 months
3.52 Retention Sample Inspection Record Up to 7 years since last entry in the record
3.53 Training Materials and Records.

Medical Records/Job Descriptions/Transfer Letters

Until the employee is no longer employed by Plant / Location / Company + 5 years
3.54 Example Signature Records Until the employee is no longer employed by

Plant / Location / Company + 5 years

3.55 Analyst Qualification related Records Until the employee is no longer employed by plant/location/company + 5 years
3.56

Analytical Testing Records

(RM, PM, FP, In-Process, etc.)

Up to 7 years since Record Sign-Off

3.57 Certificates of Analysis  of the finished product 5 years from certification of lot/batch release by Qualified Person or

1 year after the expiration date of the product, whichever is longer

3.58 Certificate of Analysis, raw materials/components

Certificate of Compliance

5 years from certification of release by Qualified Person of the last lot/batch in which the raw materials/component was used or 1 year after expiration of the last lot/batch in which the raw material/component was used or 5 years from the last requalification, whichever is longest.
3.59 Records / Data related to Clinical studies. including raw data/reports 20 Years after study finalization OR

5 Years after regulatory approval OR as per Competent Authority’s requirements, whichever is longer

3.60 Records/Data related to Pre-

Clinical/non-Clinical Studies,

including raw data/ reports

15 years
3.61 Records/Data related to

Facility/Personnel – Preclinical/non-Clinical/Clinical Facilities

Facility Life Cycle
3.62 Employee Certification Documents Retention Period to be guided by the retention Period of the document for which employee certification is performed
3.63 Volumetric solution records Up to date + 2 years
3.64 Punch inspection reports 5 Years after the destruction of punch set

4.0    REGULATORY RELATED DOCUMENTS

Sr. No Document / Record Name Record Retention Period / Archival Policy
4.1 Active or Inactive – NDA, ANDA or equivalent,

Annual Report, Supplement/Amendment,

Product License,

Establishment License Files,

Marketing Authorization(MA),

License Particular (LP),

Letter of Deficiency (LOD),

Variation Package,

MAH Approval Letter, Regulatory

Approval Letter

For “In Approval” / “Approved” / “Withdrawn /

Rejected” Applications: Product Lifecycle + 2 years

4.2 Notification to Management,

Notification to Regulatory Agencies (Field Alerts)

Facility Lifecycle.
4.3 a) Internal and Third-Party Audit Reports and Responses (manual or electronic).

b) Regulatory Audit Reports and Responses (manual or electronic).

a) After the next audit, if all commitments have been completed

b) Permanent

4.5

ODR Related Documents

4.6 a) Disclosure Program Investigations

b) Pre-Submission audits, audit

trails, related investigations, application-related data & certifications

a) 7 years (in alignment with 3.14)

b) For Audits until after next audit, if all

commitments have been completed; for

investigations 7 years (in alignment with

3.14); for application-related data and

certifications Product Lifecycle + 2 years.

 

 

pharmabeginers

Niranjan Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an updated pharmaceutical blogging platform. Email: [email protected]

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