SOP On Quality Management
Objective : To lay down a procedure for Quality Management .
Scope : This procedure is applicable for all formulation plants.
Responsibility : Head Quality Assurance shall be responsible for compliance of this SOP. Heads of Production, QC, Stores, Engineering, Administration, HR, Materials Management, Regulatory Affairs, etc. shall be responsible for implementation and compliance of the SOP.
Procedure : Quality Management Review shall be done by Quality council.
Quality Council team consists of Head or his/her designee from each department.
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 in Quality Management 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
Technology transfer
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 atleast 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.