SOP for Loan License Product Manufacturing

by
SOP for Loan License Product Manufacturing

1. Purpose

To define the procedure for manufacturing, control, and release of products under a loan license arrangement, ensuring compliance with applicable GMP guidelines and regulatory requirements.

2. Scope

This SOP applies to all products manufactured at the site under a loan license agreement for third-party (contract giver) companies.

3. Responsibility

  • Quality Assurance (QA):
    • Approval of documents, BMR/BPR review, and batch release
  • Quality Control (QC):
    • Testing of raw materials, in-process, and finished products
  • Production:
    • Manufacturing and packaging as per approved BMR/BPR
  • Warehouse:
    • Receipt, storage, and issuance of materials
  • Regulatory Affairs (if applicable):
    • Compliance with license and product permissions

4. Definitions

  • Loan License: Permission granted to a company to manufacture products at another licensed facility.
  • Contract Giver: Company that owns the product/license.
  • Contract Acceptor: Manufacturer producing the product.

5. Procedure

5.1 Agreement and Documentation

  • A Technical/Quality Agreement must be signed between contract giver and manufacturer.
  • It should define:
    • Responsibilities of each party
    • Specifications and manufacturing process
    • Change control, deviations, and complaints handling

5.2 Product and Document Approval

  • Approved documents must be available before manufacturing:
    • Master Formula Record (MFR)
    • Batch Manufacturing Record (BMR) / Batch Packaging Record (BPR)
    • Specifications and test methods
  • All documents should be approved by QA of both parties (if applicable).

5.3 Material Management

  • Raw and packaging materials may be:
    • Supplied by contract giver or
    • Procured by manufacturer as per approved specifications
  • All materials must be:
    • Received, labeled, and stored as per SOP
    • Released by QC before use

5.4 Manufacturing Process

  • Manufacturing shall be done as per approved BMR.
  • Line clearance must be performed before starting.
  • In-process checks should be recorded.
  • Any deviation must be reported and investigated.

5.5 Packaging and Labeling

  • Packaging should follow approved BPR.
  • Labels must comply with regulatory requirements (loan license number, manufacturer details, etc.).
  • Reconciliation of printed materials must be done.

5.6 Quality Control

  • Sampling and testing of:
    • Raw materials
    • In-process samples
    • Finished products
  • Testing must comply with approved specifications.

5.7 Batch Review and Release

  • QA shall review:
    • BMR/BPR
    • QC reports
    • Deviations (if any)
  • Batch release shall be done by QA of manufacturer and/or contract giver as per agreement.
  • No batch shall be released without QA approval.

5.8 Storage and Dispatch

  • Finished goods should be stored under defined conditions.
  • Dispatch shall be done only after release.
  • Distribution records must be maintained.

5.9 Change Control

  • Any changes in process, equipment, or specifications must be:
    • Approved through change control system
    • Communicated to contract giver

5.10 Deviations and Investigations

  • All deviations must be:
    • Documented
    • Investigated
    • Approved by QA
  • CAPA (Corrective and Preventive Actions) must be implemented.

5.11 Complaints and Recalls

  • Complaints must be shared between both parties.
  • Product recall procedure should be defined in agreement.

5.12 Record Retention

  • All records must be maintained as per regulatory requirements.
  • Easy retrieval should be ensured.

6. References

  • WHO GMP Guidelines
  • EU GMP Guidelines
  • US FDA 21 CFR Part 211
  • Applicable Drug and Cosmetics Act & Rules (India)
Post Views: 7