Plant GMP Committee

1.0.            OBJECTIVE:

To provide the procedure to address all the GMP related issues jointly through meeting along with action plans to maintain the GMP and GLP in the Plant conforming to national and international standards.

2.0.            SCOPE:

To maintain cGMP in the plant throughout the product cycle so that the end product is manufactured under internationally accepted standards and systems and fully comply with predefined quality standards.

3.0.            RESPONSIBILITY:

3.1.            QA executive shall be responsible to intimate all the members of GMP Committee about the schedule of the meeting.

3.2.            Manager of QA shall be accountable to prepare Minutes of Meetings.

4.0.            PROCEDURE:

4.1.            Plant GMP Committee shall comprise of following members:

4.1.1.      M.D.                                                  (Coordinator)

4.1.2.      Manager – QA                                   (Chairman)

4.1.3.      Manager – Production                        (Member)

4.1.4.      Manager – QC                                    (Member)

4.1.5.      Manager – Engineering                       (Member)

4.1.6.      Any member by invitation to address any specific issue.

4.2.            M.D. shall act as coordinators for the plant.

4.3.            GMP Committee shall meet in last week of every month subject to availability of all the members. In case of non-availability of any member, the meeting may be postponed or prepared accordingly.  In case of long leave, his immediate subordinate shall attend the meeting.

4.4.            QA Executive shall intimate all the members about the schedule of the meeting.

4.5.            Following issues related to c-GMP shall be discussed in general in every month, GMP Committee Meeting and action plan required shall be finalized:

4.5.1.        SOPs

4.5.2.        Process Deviations

4.5.3.        GMP Violations

4.5.4.        Cost of failure

4.5.5.        Facilities

4.5.6.        Internal Audits

4.5.7.        Process Problems

4.5.8.        Sanitation

4.5.9.        Hygiene

4.5.10.    Out of Specification

4.5.11.    Market Complaints

4.5.12.    Validation

4.5.13.    Rejection

4.5.14.    Recall of marketed products

4.5.15.    Any issue directly or indirectly related with cGMP

4.6.            Minutes shall be prepared by QA manager with the action plan and probable date of completion and shall be distributed to every member.

4.7.            The minutes of the meeting shall be sent to G.M for review. Any specific point, which requires guidance, shall be discussed with him during his schedule visit to facility.

5.0.            ANNEXURE:

Nil

6.0.            REFERENCES:

Nil

7.0.            ABBREVIATION     :

Abbreviation used       Full form of abbreviation used

GMP                           Good Manufacturing Practices

cGMP                          Current Good Manufacturing Practices

GLP                            Good Laboratory Practices

SOPs                           Standard Operating Procedures

QA                              Quality Assurance

G.M.                            General Manager

QC                              Quality Control

8.0.            DISTRIBUTED TO:

Quality assurance

Manufacturing

Quality Control

HR & Administration

Engineering

9.0.            REVISION HISTORY:

Revision No.	Change Control Number	Reason for the Modifications