Tablets: SOP for Vendor Qualification for Raw Materials Used in Tablets – V 2.0

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Tablets: SOP for Vendor Qualification for Raw Materials Used in Tablets – V 2.0

Standard Operating Procedure for Vendor Qualification for Raw Materials Used in Tablets

Department Tablet
SOP No. SOP/TAB/177/2025
Supersedes SOP/TAB/177/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To establish the procedures for vendor qualification to ensure that raw materials used in tablet manufacturing meet the required quality standards, comply with GMP, and are safe for use in pharmaceutical production.

2. Scope

This SOP applies to all raw materials suppliers used in tablet manufacturing, including active pharmaceutical ingredients (APIs) and excipients. It covers the qualification process, periodic evaluation, and requalification of vendors.

3. Responsibilities

  • Purchasing Department: Responsible for selecting and contacting potential vendors, ensuring that all vendor information is collected, and initiating the qualification process.
  • Quality Assurance (QA): Responsible for evaluating and approving vendors based on their compliance with quality standards and regulatory requirements, conducting audits, and maintaining vendor qualification records.
  • Quality Control (QC): Responsible for reviewing material specifications, conducting testing on raw materials, and ensuring that materials meet the required quality criteria.
  • Vendor: Responsible for providing all required documentation, including Certificates of Analysis (CoA), product samples, and ensuring compliance with quality and regulatory standards.

4. Accountability

The QA Manager is accountable for overseeing the vendor qualification process and ensuring compliance with quality standards. The Purchasing Department is responsible for initiating and maintaining vendor relationships.

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5. Procedure

5.1 Vendor Selection

  1. The Purchasing Department is responsible for identifying potential vendors based on the requirements for raw materials, such as quality, cost, and delivery schedules.
  2. Initial vendor selection must be based on a review of the vendor’s reputation, regulatory compliance history, and ability to meet company needs.
  3. Once a vendor is selected, the Purchasing Department initiates the qualification process by sending a Vendor Qualification Questionnaire (Annexure-1) to the vendor.

5.2 Vendor Evaluation

  1. The QA team reviews the completed Vendor Qualification Questionnaire to assess the vendor’s compliance with GMP, regulatory requirements, and their quality management system.
  2. The vendor must provide the following documents for evaluation:
    • Certificate of Analysis (CoA) for each raw material
    • Batch records and manufacturing processes
    • Evidence of GMP certification or compliance
    • Quality assurance procedures and controls
  3. The QA team evaluates the vendor’s quality control testing procedures, stability data, and any other relevant documentation.
  4. If needed, the QA team may perform an on-site audit of the vendor’s manufacturing facility to assess compliance with the company’s quality standards and regulatory requirements.

5.3 Vendor Approval

  1. Once the evaluation is complete, the QA team approves or rejects the vendor based on their ability to meet the required quality and regulatory standards.
  2. If approved, the vendor will be added to the Approved Vendor List (AVL), and the vendor’s raw materials can be used in tablet production (Annexure-2).
  3. The Purchasing Department is notified of the vendor’s approval, and the vendor’s information is maintained in the vendor database for future reference.

5.4 Initial Material Testing

  1. Before the first batch of raw materials is used, the QC team performs testing to verify that the raw materials meet the specified quality standards and are consistent with the vendor’s documentation (e.g., CoA, specification sheets).
  2. Tests should include physical, chemical, and microbiological testing as applicable to the raw material.
  3. Only raw materials that pass testing will be released for use in production.
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5.5 Ongoing Vendor Evaluation and Requalification

  1. Vendors must be periodically re-evaluated to ensure that they continue to meet the required standards. The frequency of requalification depends on the criticality of the material supplied and any changes to regulatory requirements.
  2. Vendor performance is reviewed annually, based on criteria such as quality, delivery performance, and compliance with specifications.
  3. If any issues arise with a vendor’s materials or performance, the QA team may initiate an investigation and corrective actions, which may include temporary suspension of material usage from that vendor until the issue is resolved.
  4. In case of significant changes (e.g., change in manufacturing process, change in material specifications), the vendor must notify the QA team for requalification.

5.6 Vendor Audit

  1. On-site vendor audits are conducted by the QA team to evaluate the vendor’s manufacturing practices, quality control systems, and compliance with GMP.
  2. The frequency of audits depends on the criticality of the material, the vendor’s history of compliance, and regulatory requirements. Vendors may be audited annually or biannually.
  3. The audit findings are documented, and any deficiencies identified are addressed by the vendor through corrective and preventive actions (CAPA). These actions are monitored by the QA team until resolved.

5.7 Documentation and Record Keeping

  1. Maintain records of all vendor qualification activities, including the Vendor Qualification Questionnaire, evaluation reports, audit findings, and approval documents (Annexure-3).
  2. All vendor-related documents should be stored securely and readily available for review during internal audits and regulatory inspections.
  3. Vendor qualification records should be retained for at least five years or as required by regulatory guidelines.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • CoA: Certificate of Analysis
  • AVL: Approved Vendor List

7. Documents

  1. Vendor Qualification Questionnaire (Annexure-1)
  2. Approved Vendor List (Annexure-2)
  3. Vendor Qualification Record (Annexure-3)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • ISO 9001 – Quality Management Systems
  • ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Vendor Qualification Questionnaire

Vendor Name Material Supplied Regulatory Compliance Quality Certifications Audit Frequency
XYZ Supplier Excipient A ISO 9001, GMP Certified FDA, EMA Annually

Annexure-2: Approved Vendor List

Vendor Name Material Supplied Approval Status Approval Date
XYZ Supplier Excipient A Approved 01/01/2026

Annexure-3: Vendor Qualification Record

Vendor Name Evaluation Date Evaluation Outcome Action Taken
XYZ Supplier 01/01/2026 Approved Vendor added to AVL

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated vendor qualification process Revised approval and evaluation steps QA Head
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