SOP FOR MANAGEMENT REVIEW MEETING
PURPOSE: The purpose of this SOP is to lay down the procedure for regular Quality management review meeting to determine the performance and effectiveness of in product development, regulatory approval, dossier compliance and GMP scenario during routine and associated documentation.
SCOPE: This SOP is applicable for product development, regulatory approvals, dossier compliance and GMP scenario during routine work and associated document to all departments.
RESPONSIBILITY:
Preparation of SOP: Officer / His Designee
Review & checking of SOP: Sr. officer / his Designee
Approval of SOP: Executive / His Designee
Authorization of SOP: Head QA / His Designee
Review meeting and prepare schedule with consultation of head QA / Designee.
QA – Control, issuance, retrieval and destruction of SOPs.
ACCOUNTABILITY:
The accountability of implementation and compliance of SOP lies with the Head Quality assurance.
PROCEDURE:
cGMP Committee:
cGMP committee consists of to discuss quality issue in day-to-day basis arrived during functioning of QMS at plant.
Team members of cGMP committee consist of representative of each department either HOD’s of their representatives.
The leader of committee is any of management / plant head / QA Head.
The head of concerned department is responsible for the implementation of quality system and maintain cGMP.
Quality Meeting:
The scope of quality meeting is as follow:
Review the compliance of cGMP requirement.
Review the current status related to quality, safety & efficacy of products.
Effectiveness of system & procedure.
Based on the trend which indicates that procedure is needed to be reviewed.
Compliance with the regulatory guideline.
Any other need based, which may affect the quality, safety & efficacy of product.
Call all HOD’s or designee to meet for quality meeting in every three month or whenever required.
Fill the attendance sheet
Quality meeting Agenda:
Update the agenda of previous meeting.
Review the following points during quality meeting but not limited to.
Stability study report.
Internal / External audits report.
Open change control.
Reoccurring of deviation and incident.
Risk Assessment reports.
Market complaints and product recall, if any.
Open CAPA and CAPA effectiveness.
OOS and OOT results.
Any excursion observed in validation.
Any excursion observed during Qualification and calibration.
Any excursion observed during preventive maintenance.
Product and material related issues.
Vendor related issues.
Any other cGMP related issues.
SOP effectiveness.
Online documentation (GDP).
Breach data integrity reporting.
Training effectiveness.
Environmental monitoring report.
Monthly water report
Health & hygiene condition of employee.
Product failure.
APQR
Minutes of Meeting:
QA Head organize the minute of meeting and lead the meeting on following basis.
Any trend results.
Any previous agenda is not closed.
Any major Discrepancy is found.
Fill such agenda
The cGMP committee finding /quality reports are for internal / quality reports are for internal review.
Improvement and concern in product development, client handling, dossier submission, dossier compilation, training, availability of resources, regulatory queries, success in regulatory approvals, organization development, requirement of procurement of resources and personal (but not limited to) shall be discuss during meeting.
Outcome of meeting shall be documented, and the quality management review meeting report shall be signed by concerned personal presence in meeting.
The assigned action of quality management review meeting shall be decided in next quality Management review meeting.
Minutes of meeting of quality management review meeting shall be prepared.
Each Quality management review meeting shall assign with unique number.
The Quality management review meeting shall be numbered as following pattern:
MRM/YY/ZZZZ
Where
MRM represents: Management Review Meeting
YYYY the represents the current year.
ZZ represent serial number
REFERENCES
SOP FOR SOP