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