SOP on Quality Management


1.0 Objective

To lay down a procedure for Quality Management .

2.0 Scope

This procedure is applicable for pharmaceutical formulation plants.

3.0 Responsibility

3.1 Head Quality Assurance shall be responsible for compliance of this SOP

3.2 Heads of Production, QC, Stores, Engineering, Administration, HR, Materials Management, Regulatory Affairs, etc. shall be responsible for implementation and compliance of the SOP.

4.0 Abbreviations and Definitions

SOP                            :           Standard Operating Procedure

STP                             :        Standard Test Procedure

QA                               :        Quality Assurance

QC                               :        Quality Control

CAPA                            :        Corrective and Preventive Action

NCR                               :       Non conformance.

5.0 Procedure

5.1 Quality Management Review shall be done by Quality council.

5.2 Quality Council team consists of Head or his/her designee from each department.

5.3 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.

5.4 Following points shall be discussed in Quality Management meeting; points are indicative only, the Review may not be limited to these points.

5.4.1 Batch Manufacturing records and other Production records.

5.4.2 NCR, Deviations, CAPA and change control.

5.4.3 System failures in the manufacturing process.

5.4.4 SOPs, STPs and Specifications etc

5.4.5 Technology transfer

5.4.6 Product complaints and Product recalls

5.4.7 Internal Audits/Quality system

5.4.8 Plan Vs Actual

5.4.9 Availability of materials as per the plan

5.4.10 Capacity Utilization

5.4.11 Cost effectiveness

5.4.12 Manpower Utilization

5.4.13 Preventive maintenance of critical equipments

5.4.14 New initiatives for continuous improvement

5.5 Operation and Quality Review meetings shall be organized atleast once in every quarter of a calendar year.

5.6 Meeting shall be concluded with possible solutions for all issues raised in meeting.

5.7The 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.

6.0 Forms and Records


7.0 Distribution

7.1   Master Copy                                     : Documentation Cell (Quality Assurance)

7.2   Controlled Copies                            : Quality Assurance, Quality Control, Production, Stores, Finished goods warehouse, Engineering, Regulatory Affairs, Research and Development, Materials Management, Human resource, Administration & Housekeeping

8.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP