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Management Review

Management Review

  • OBJECTIVE:

To have a systematic approach for Management Review through meetings to review Quality Management System (QMS) with an objective to monitor product quality, products status and processes, identify improvements required in system, process and resources, review of quality risks throughout product life-cycle and to review if the whole QMS complies as per internal requirements and GMP.

  • SCOPE:

This procedure is applicable for the Management Review meeting at  Pharmaceutical company.

  • RESPONSIBILITY:

QA Head / designee will organize the management review meeting with the senior managements and all respective department heads.

  • ACCOUNTABILITY:

QA Head shall be accountable for the compliance of the procedure mentioned in this SOP.

  • ATTACHMENTS:

Management Review Meeting Report– Attachment – I

Management Review Meeting Planner– Attachment – II

Minutes of Meeting– Attachment – III

External Audits -Attachment – IV

Out of Specification (OOS)-Attachment – V

Product Complaints-Attachment-VI

Change Control-Attachment-VII

Vendor Management (complaints)-Attachment-VIII

Deviations-Attachment-IX

Corrective and Preventive Action (CAPA)-Attachment-X

Revalidations-Attachment-XI

Batches details  /product wise-Attachment-XII

Raw Material-Attachment-XIII

Water Sample-Attachment-XIV

Environmental Monitoring Samples -Attachment-XV

  • PROCEDURE:

The management review meeting for the quality system review shall be organized by QA Head / designee on quarterly basis. A written schedule for the year shall be prepared and circulated to senior managements and other attendees, however in case of an emergency situation; it can be preponed from the scheduled time to review the quality issues, as and when required.

The meeting shall be attended by the following personnel (but may not be limited to)

Managing Director

Quality Assurance Head / Designee

Quality Control Head / Designee

Production Heads / Designee

Engineering Head / Designee

Warehouse Head / Designee

Management review meeting shall involve the review of the following elements including key performance indicators to monitor the Quality Management System.

Key performance indicators:

Process Validation

Hold Time Study

Cleaning Validation

Qualification/Re-qualification

BMR/BPR Issuance Records

Approval/Specs/STPs

Technical Information sheet status

Approval and implementation of SOP

Review of MMFs

Status of PVP / PVSR

NCR’s

Incidents

Audits

Market complaints and Product recall

Deviations

Change control

Stability study status

Vendor management

OOS/OOT

Trainings

Artworks / shade card

Manpower status

Product quality review

Note:  The elements mentioned above may be revised based on the requirements.

Image result for management review

Previous meeting minutes shall be also reviewed during the Management Review Meetings.

The above-mentioned parameters shall be reviewed on Quarterly basis and data collated on above shall be made part of the management review meeting report as per Attachment -I

The management review meeting report shall have summary of the management review Meeting along with data on key performance indicator.

Based upon the management review meeting, report filled  for all Key performance indicators, QA Head shall prepare a summary of the Management Review on the important KPI (Key Performance Indicators).

Minutes of the meeting shall be prepared after each review meeting and circulated to the senior management.

Senior management shall review the reports and minutes of the Management Review Meeting and conclude if the current activity complies as per current in house requirements and propose any change / updations if deemed necessary.

  • REFERENCES:

 SOP on SOP

  • ABBREVIATIONS:

SOP: Standard Operating Procedure

QA:  Quality Assurance

QMS:Quality Management System

OOS:Out of specification.

OOT:Out of trend.

CAPA:Corrective and Preventive action

R&D:Research and development

RA:   Regulatory affairs

KPI:  Key Performance Indicators

PVP: Process validation protocol

PVSR:Process validation summary report

MMF:Master Manufacturing Formula

NCR: Non-conformance report

BMR:Batch Manufacturing Record

BPR: Batch Packing Record

STP: Standard Test Procedure

  • DISTRIBUTION LIST :

Managing Director

Quality Assurance

Quality Control

Production

Engineering

Warehouse

  • HISTORY OF REVISION:
Version Number Effective Date Reason for Revision
00 New SOP

Attachment-I

Management Review Meeting Report

Date:

Point No. Activities Report
1 Process Validation
2 Hold Time Study
3 Cleaning Validation  
4 Qualification/Re-qualification  
5 BMR/BPR Issuance Records
6 Approval/Specs/STPs
7 Technical Information sheet status
8 Approval and implementation of SOP
9 Review of MMFs
10 Status of PVP / PVSR
11 NCR’s
12 Incidents
13 Audits
14 Market complaints and Product recall
15 Deviations
16 Change control
17 Stability study status
18 Vendor management
19 OOS/OOT
20 Trainings
21 Artworks / shade card
22 Manpower status
23 Product quality review

Attachment-II 

Management Review Meeting Planner

Year __________

  Tentative Date of Meeting Actual Date of Meeting Remarks
1st Quarterly Meeting      
2nd Quarterly Meeting      
3rd Quarterly Meeting      
4th Quarterly Meeting      

Attachment-III 

Minutes of Meeting

Name of Participants Designation Signature Date

 

Sr. No. Matter discussed Outcome of Meeting Responsibilities for Compliance Date for

Compliance

         
         
         

Attachment-IV

External Audits
Comments : 

 

Adherence to plan
Number performed
Number scheduled
% adherence to plan

 

External Audits Number of critical findings Number of major findings Number of minor findings

Attachment-IX 

OOS
Comments 

 

OOS (Open/Close)

 

OOS in Opened(Under approval/closing) Closed (Approved and closed) Open (Initiated) Investigation

Attachment-V 

Product Complaints
Comments : 
 Months                    
No. of complaints received
Overdue complaints
No. of units sold
Investigation
% closed on time
% overdue

Attachment-VI

Change Control
Comments : 
Changes open/close
Month      
Initiated
Carry over from previous month
Closed
Open
% carry over
% Open

Attachment-VII 

Vendor Management (complaints)
Comments: 
Per category (RM) /month
Logistic Problems
Damage
Packaging Problems
OOS
Foreign Matters
Missing Documentation
Others
Total                    

Attachment-VIII 

Deviations
Comments
Deviation Open/Close Reported Closed (Approved and Closed) Open
Total  till date
 

No. of Deviation

Per month
Open    
Closed    

Attachment-X 

CAPA
Comments:

 

CAPA open/close Initiated Closed (Approved and closed) Open (Under way) Status Timeline for closing
 

Attachment-XI

Revalidations
Comments:

 

Revalidation- initiated/close Planned Initiated Completed
(Closed)
open Status Timeline for completion

Attachment-XII 

Batches details  /product wise
Comments: 
Details of batches manufactured, tested and released   
Department No of batches manufactured   Tested   Released  Rejected Destroyed
   
   

Attachment-XIII

Raw Material
Comments:
Raw material- Approved /Rejected Received  Approved Under Testing Rejected

Attachment-XIV 

Water Samples
Comments:
No of samples Tested/ per month Approved  Rejected

Attachment-XV

Environmental Monitoring Samples
Comments:
No of samples Tested/ per month No of sample Complies to acceptance criteria OOS / OOT ( if any )

 

 

 

 

 

 

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He 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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