It ensures secure storage, controlled access, and compliance with applicable regulatory and quality system requirements.

2. Scope

This SOP applies to all hardcopy and electronic method development reports associated with analytical activities performed for new drug substances, drug products, process intermediates, excipients, and stability studies under the AMD department.

3. Responsibilities

• Analytical Scientist: Prepares MDRs in standard format and submits for review and approval.
• Reviewer: Evaluates content accuracy, completeness, and adherence to data integrity principles.
• QA: Verifies document compliance and records archival details.
• Document Controller: Maintains the master archive, ensures indexing, access control, and retrieval.

4. Accountability

The Head of AMD is accountable for ensuring that all method development reports are approved, archived, and retrievable in accordance with current Good Documentation Practices (GDP) and GMP regulations.

5. Procedure

5.1 Report Preparation and Review

1. Each MDR must include:
   • Title Page
   • Analytical Target Profile (ATP)
   • Experimental Conditions
   • Trials, Observations, and Rationales
   • Finalized Method Parameters
   • Conclusion and Recommendations
2. Format must follow the template described in Annexure-1: Method Development Report Template.
3. Review and approval to be documented using Annexure-2: Report Approval Form.

5.2 Document Indexing and Numbering

1. Assign a unique MDR number: e.g., MDR/AMD/023/2025
2. Record MDR details in Annexure-3: MDR Index Register, including:
   • Product Name
   • MDR No.
   • Author
   • Review and Approval Dates

5.3 Archival Process

1. Submit approved MDRs to QA for archival.
2. QA checks the completeness of annexures, signatures, attachments (chromatograms, spectra, graphs).
3. Hardcopy reports:
   • Stamped as “Archived” with date and reviewer initials
   • Placed in a labeled binder and stored in a fire-resistant cabinet
4. Electronic reports:
   • Stored in the Document Control System (DCS)
   • Access restricted to authorized AMD and QA personnel
5. Archival details entered in Annexure-4: Archive Location Register.

5.4 Retrieval and Reissue

1. Request for archived reports must be made using Annexure-5: MDR Retrieval Request Form.
2. QA shall authorize retrieval and maintain logs for:
   • Person retrieving
   • Date and purpose
   • Return confirmation

5.5 Retention Period and Destruction

1. Retention:
   • Minimum 10 years from date of approval
   • Or as specified by regulatory project requirement
2. After expiry:
   • Obtain approval from QA and Head – AMD
   • Destruction via shredding (paper) or secure deletion (electronic)
   • Document in Annexure-6: Destruction Record

6. Abbreviations

• AMD: Analytical Method Development
• MDR: Method Development Report
• QA: Quality Assurance
• DCS: Document Control System
• GDP: Good Documentation Practices

7. Documents

1. Method Development Report Template – Annexure-1
2. Report Approval Form – Annexure-2
3. MDR Index Register – Annexure-3
4. Archive Location Register – Annexure-4
5. MDR Retrieval Request Form – Annexure-5
6. Destruction Record – Annexure-6

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Subpart J: Records and Reports
• WHO TRS 1019 – Annex 5: Record Management and Archiving

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Method Development Report Template

Section	Content
Title	Method Development Report for [Product Name]
Author	Rajesh Kumar
Date	01/05/2025

Annexure-2: Report Approval Form

Prepared By	Reviewed By	Approved By
Ajay Verma	Sunita Reddy	QA Head

Annexure-3: MDR Index Register

MDR No.	Product	Author	Approval Date
MDR/AMD/023/2025	API-X	Ajay Mehra	03/05/2025

Annexure-4: Archive Location Register

MDR No.	Location	Archived By	Date
MDR/AMD/023/2025	Shelf C4	QA Officer	04/05/2025

Annexure-5: MDR Retrieval Request Form

Date	Requested By	MDR No.	Purpose	Approved By
10/05/2025	Meenal Patil	MDR/AMD/023/2025	QbD Filing	QA Manager

Annexure-6: Destruction Record

MDR No.	Destruction Date	Approved By	Method
MDR/AMD/003/2010	01/05/2025	QA Head	Shredded

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Updated annexures and electronic archival workflow	Document control compliance