Quality Management Review

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

DateRevision NumberReason for Revision
INew SOP

 

 

 

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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