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Management Review

Management Review

Objective

To have a systematic approach for quality review as per Quality Management System (QMS) with a objective to monitor product quality, validated status of products and related processes, identify improvements required in manufacturing process and systems and take care of quality risks throughout product life-cycle.

Scope

This procedure is applicable for the Management review at Pharmaceutical Company.

Responsibility

  • Head-QA / designee will organize the meeting for management quality review
  • All respective functional heads to attend the review meetings arranged by QA.

Accountability

  • Head – QA
  • Head – Operations

Procedure

  • The management review meeting for the quality review shall be organized by Quality Assurance on quarterly basis, however, in case of an emergency situation; it can be proponed from the scheduled time to review the quality issues, as and when required.
  • The intimation to all for the date and venue shall be provided by the Quality Assurance two days prior to the meeting.
  • The meeting shall be attended by the following personnel (but may not be limited to)
    • Quality Head
    • Head operations
    • Production Heads / Designee
    • Engineering Head / Designee
    • Quality Assurance Head / Designee.
    • Quality Control Head / Designee
    • Regulatory Head / Designee
  • Management review meeting shall involve the review of the following elements including key performance indicators to monitor the quality management system across the location.
    • Key performance indicators,
      • Regulatory Inspection findings & it’s compliance status
      • Product Complaints
      • Product Recalls
      • Internal Audits findings & it’s compliance status
      • External/ Customer Audit findings & it’s compliance status
      • Number of batches rejected / Product wise & CAPA thereof
      • Vendor management
      • OOS/ OOT
      • Change control. (Complete, Under Progress & Planned)
      • Deviations (Planned & Unplanned)
      • CAPA
      • Product quality review
    • Other elements are:
      • Number of Raw material tested and it’s outcome.
      • Number of Finished products tested and it’s outcome.
      • Number of Water samples tested and its outcome.
      • Number of Environment monitoring samples tested and its outcome.
      • Status of personnel training and assessment
      • Validation and revalidations conducted & further plan.
      • Regulatory Compliance

Note:  The elements mentioned above shall be revised based upon the rolling quality review system.

  • The above-mentioned parameters shall be reviewed on monthly basis by QA head/ designee and data collated on above shall be made part of the monthly quality report as per the template given in annexure.
  • The monthly quality report shall have summary of the quality review report on the first page along with data on key performance indicator. The data on the other elements shall be provided on the second page onwards with appropriate trend analysis, graphs etc.
  • Based upon the monthly quality reports filled  for all Key performance indicators, QA shall prepare a summary of the monthly quality report considering important KPI (Key Performance Indicators) for the management review.

Minutes of the meeting shall be prepared for each review meeting and recorded.

List of Annexure and Formats

  • Monthly Quality Report
  • Inspection Findings
  • Internal Audits
  • External Audits
  • Product Complaints
  • Change Control
  • Vendor Management
  • Deviations
  • Out of Specification
  • Corrective and Preventive Actions
  • Revalidations
  • Batch Details / Product wise
  • Raw Material
  • Water Samples
  • EMP Samples

References

  • SOP on SOPs.

Reason for Revision

  • Not applicable due to first version

Abbreviations

  • QA :           Quality Assurance
  • QC :           Quality Control
  • QMS:           Quality Management System
  • KPI:           Key Performance Indicators
  • OOS:           Out of specification.
  • OOT:           Out of trend.
  • CAPA :           Corrective and Preventive action
  • CEO :           Chief Executive Officer.

 

Monthly Quality Report

Month _________ Year_________

Summary (Brief Description) :
Regulatory Inspection findings & it’s compliance status
Product Complaints
Product Recalls
Internal Audits findings & it’s compliance status
External/ Customer Audit findings & it’s
Compliance status
Number of batches rejected / Product wise & CAPA thereof
Vendor management
OOS/ OOT
Change control. (Complete, Under Progress & Planned)
Deviations (Planned & Unplanned)
CAPA
Product quality review

 

Inspection findings

Open and Overdue
Open (Within timeline)
Closed (Total)
Open (Total)

 

 CAPA 

Initiated
Closed
Open
Overdue

Internal audits

Adherence to plan ( Planned Audit)
Number of critical findings
Number of major findings
Number of minor findings
Unplanned audit
Number of critical findings
Number of major findings
Number of minor findings

 

OOS/ OOT

Reported
Closed
Open
Overdue

 

Deviations
Reported
Closed
Open
Overdue

 

Change Control
 Initiated
Carry over
Closed
Open

 

Product Recall
Batch No:
No. of doses recalled

 

Complaints

No. of complaints received
overdue complaints
No. of units sold
Investigation
% closed on time
% overdue

 

Vendor Management

Month No of complaints  

 

External Audit
Adherence to plan
Number of critical findings
Number of major findings
Number of minor findings

 

Inspection findings
Comments :

 

Current status per type: Complete Open
(within timeline)
Open Overdue Total
Critical
Major
Other
Total

 

Internal Audits
Comments :

 

Adherence to plan  
Number performed
Number scheduled
% adherence to plan

 

Internal Audits Number of critical findings Number of major findings Number of minor findings

 

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

 

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

 

Change Control
Comments :
Changes open/close
Month      
Initiated
Carryover from previous month
Closed
Open
% carryover
% Open

 

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

 

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

No. of Deviation

Per month
Open    
Closed    

 

OOS
Comments

 

OOS (Open/Close)

 

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

 

CAPA
Comments:

 

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

 

Revalidations
Comments:

 

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

 

Batches details  /product wise
Comments:

 

Details of batches manufactured, tested and released   
Department No of batches manufactured   Tested   Released  Rejected Reprocessed Destroyed
           
   

 

Raw Material
Comments:

 

Raw material- Approved /Rejected Received  Approved Under Testing Rejected

 

Water Samples
Comments:

 

No of samples Tested/ per month Approved  Rejected

 

EMP Samples
Comments:

 

No of samples Tested/ per month No of sample Complies to acceptance criteria OOS / OOT ( if any )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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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