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.
This procedure is applicable for the Management Review meeting at Pharmaceutical company.
QA Head / designee will organize the management review meeting with the senior managements and all respective department heads.
QA Head shall be accountable for the compliance of the procedure mentioned in this SOP.
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
Vendor Management (complaints)-Attachment-VIII
Corrective and Preventive Action (CAPA)-Attachment-X
Batches details /product wise-Attachment-XII
Environmental Monitoring Samples -Attachment-XV
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)
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:
Hold Time Study
BMR/BPR Issuance Records
Technical Information sheet status
Approval and implementation of SOP
Review of MMFs
Status of PVP / PVSR
Market complaints and Product recall
Stability study status
Artworks / shade card
Product quality review
Note: The elements mentioned above may be revised based on the requirements.
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.
SOP on SOP
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 :
- HISTORY OF REVISION:
|Version Number||Effective Date||Reason for Revision|
Management Review Meeting Report
|2||Hold Time Study|
|5||BMR/BPR Issuance Records|
|7||Technical Information sheet status|
|8||Approval and implementation of SOP|
|9||Review of MMFs|
|10||Status of PVP / PVSR|
|14||Market complaints and Product recall|
|17||Stability study status|
|21||Artworks / shade card|
|23||Product quality review|
Management Review Meeting Planner
|Tentative Date of Meeting||Actual Date of Meeting||Remarks|
|1st Quarterly Meeting|
|2nd Quarterly Meeting|
|3rd Quarterly Meeting|
|4th Quarterly Meeting|
Minutes of Meeting
|Name of Participants||Designation||Signature||Date|
|Sr. No.||Matter discussed||Outcome of Meeting||Responsibilities for Compliance||Date for
|Adherence to plan|
|% adherence to plan|
|External Audits||Number of critical findings||Number of major findings||Number of minor findings|
|OOS in||Opened(Under approval/closing)||Closed (Approved and closed)||Open (Initiated)||Investigation|
|No. of complaints received|
|No. of units sold|
|% closed on time|
|Carry over from previous month|
|% carry over|
|Vendor Management (complaints)|
|Per category (RM) /month|
|Deviation Open/Close||Reported||Closed (Approved and Closed)||Open|
|Total till date|
No. of Deviation
|CAPA open/close||Initiated||Closed (Approved and closed)||Open (Under way)||Status||Timeline for closing|
|open||Status||Timeline for completion|
|Batches details /product wise|
|Details of batches manufactured, tested and released|
|Department||No of batches manufactured||Tested||Released||Rejected||Destroyed|
|Raw material- Approved /Rejected||Received||Approved||Under Testing||Rejected|
|No of samples Tested/ per month||Approved||Rejected|
|Environmental Monitoring Samples|
|No of samples Tested/ per month||No of sample Complies to acceptance criteria||OOS / OOT ( if any )|
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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