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
- Key performance indicators,
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 ) |