Quality Management Review

By /

Quality Management Review

Objective

  • To lay down a procedure for Quality Management.

Scope

  • This Standard Operating Procedure shall apply to formulation plant of Pharma Company.

Responsibility

    • Head Quality Assurance shall be responsible for compliance of this SOP.
    • Heads of Production, QC, Stores, Engineering, and Human Resource etc. shall be responsible for implementation and compliance of the SOP.

Accountability  

    • QA Head / designee shall be accountable for implementation of this SOP. 

Abbreviations and Definitions

  • SOP                 :           Standard Operating Procedure
  • STP                 :           Standard Test Procedure
  • QA                  :           Quality Assurance
  • QC                  :           Quality Control
  • CAPA             :           Corrective and Preventive Action
  • NCR                :           Nonconformance.

Procedure

    • Quality Management Review shall be done by Quality Head.
    • Quality Management shall provide the framework for implementing the quality procedures, check the suitability, adequacy and effectiveness of the quality system, continuous improvement and risk management.
    • Following points shall be discussed under Quality Management review meeting; points are indicative only, the review may not be limited to these points.
      • Batch Manufacturing records and other Production records.
      • NCR, Deviations, CAPA and change control.
      • System failures in the manufacturing process.
      • SOPs, STPs and Specifications etc.
      • Product complaints and Product recalls
      • Internal Audits/Quality system
      • Plan Vs. Actual
      • Availability of materials as per the plan
      • Capacity Utilization
      • Cost effectiveness
      • Manpower Utilization
      • Preventive maintenance of critical equipments
      • New initiatives for continuous improvement
    • Operation and Quality Review meetings shall be organized at least once in every quarter of a calendar year.
    • Meeting shall be concluded with possible solutions for all issues raised in meeting.
    • The Recordings of the Quality Management meetings are confidential in nature and shall not be available to external agencies/ Auditors. The Selective information may be made available based upon the discretion of the company management. 

Forms and Records (Annexures)

  • Not Applicable 

Distribution

  • Master Copy                    –                Quality Assurance
  • Controlled Copies              –               Quality Control, Quality Assurance, Stores, Production, Engineering, Human Resources

History

Date Revision Number Reason for Revision
I New SOP

 

 

 

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