STANDARD OPERATING PROCEDURE CHANGE CONTROL

STANDARD OPERATING PROCEDURE

SUBJECT :                                             CHANGE CONTROL

DEPARTMENT         : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP VERSION            :

1.0        OBJECTIVE:

To lay down a procedure for control of any changes in specifications, instruments, analytical methods, equipment, manufacturing and packaging operations, suppliers, documents which have potential impact on product safety, identity, strength, quality, purity, stability or validated state and to identify the items which shall be subject to such control.

2.0                   SCOPE:

This change control system shall apply for controlling, authorization, approvals, amendments and implementation of changes pertaining to but not limited to following:

2.1              Raw materials, starting materials, intermediates and packaging components used in the products.

2.2                   Manufacturers and distributors of the above items.

2.3                   Manufacturing formulas.

2.4                   Manufacturing and packaging processes.

2.5                   Master batch records and master packaging records, Labels and labeling.

2.6                   Primary container/closure systems and packaging configurations.

2.7                   Equipment used in manufacturing, packaging and testing.

2.8                   Utilities (e.g. Air, water, nitrogen, compressed gases) used in or in support of manufacturing.

2.9              Packaging and testing functions.

2.10          Computerized and automated systems used for GMP related purposes (including distribution   

                        operations, and inventory management).

2.11      Calibration and maintenance procedures and schedules.

2.12      Cleaning and sanitation procedures for direct contact equipment and selected non-contact    

                        surfaces and areas.

2.13      Tests methods and specifications (analytical, microbiological, biological and cleanliness  

verification tests),

Emergency changes, Like for like changes

Facility changes.

3.0                   PROCEDURE:

3.1       The proposal for the change will be initiated by the concerned department/initial or and forwarded to the change control committee on the prescribed form for approval. The initiator/initiating department must submit the change control form along with the supporting documents and also ensure that all the appropriate sections are filled in by the initiator/initiating department before it is submitted to the change control committee

             The changes may be classified as;

3.2.0        Major change like:

3.2.1        Any change to the material, equipment or procedure that may have a significant impact on the  

process or product.

3.2.2        Any change which requires testing, acceptance and that which may require approval of  

regulatory body (e.g. F.D.A.) before implementation.

3.2.3     A new product introduction.

3.2.4     Line extension to an existing product.

3.2.5     A change in manufacturing site, which involves changes in the formula, manufacturing   

                        procedure equipment and Q. A. testing.

3.3.0        Minor changes and Other changes:

3.3.1                Any change in the equipment, materials or procedures that will have no significant impact on the process or product.

3.3.2     Any change that requires documentation, and may be implemented immediately upon approval.

3.3.3     Change in general procedure for working in manufacturing area and laboratories.

3.3.4     Change in the manufacturing and laboratory equipment and instrument.

3.3.5        Change in the text or color of printed packaging material.

3.3.6        Change in the in-house specification of raw materials, in-process intermediates and finished     

             product specifications.

3.3.7        Change in the test procedure/method of analysis.

3.3.8        Change in the location of equipment/instruments.

3.3.9        All the above mentioned minor changes will be approved by the site change control committee only.

3.3.10    In case of like for like replacement, a change control form needs to be filled. The Change control committee must approve the change control form before initiating the action. The   change control committee members are provided in Annexure-1 Sop NoQA. The change after implementation will need to be qualified (Installation, Operation and Performance).

3.3.11   If the change control is approved by the site change control committee, the initiating

division/department will then co-ordinate the implementation of the change according   

            to the condition stated in the approved change control request provided in Annexure-2    

            Sop No. /QA. Any changes need the review and approval of Microbiologist.

3.3.12    All the documents affected by the change will be reviewed and revised accordingly by Q.A.

3.3.13    The Q. A will duly maintain change control requests.

3.3.14    Equipment, instruments and the associated processes and/or procedures and documents must not be altered, enhanced, modified or substituted without following the change Control system.

3.3.15    The site change control committee using the change control request will approve any amendment to the site change control procedure.

3.3.16    To ensure the effectiveness of the change must track the change control for appropriate time.

To use any suitable tracking system/device to ensure effectiveness of change.

3.3.17    All change controls should  be notified or approved by the representative of the principal          

company and the representative  to sign  off on the change control form & incase of P&G to inform site leader before change is made.

3.3.18 If the change requires any validation it should be mentioned in the change control form.

4.0       FREQUENCY: As and when required.

5.0       RESPONSIBILITY: Change control committee & G.M- QA

6.0       REVIEW GUIDE: Change control forms

7.0       ANNEXURES: 1. Change Control Committee. 2. Change Control Format.

                                     3. Transfer Closeout/Hand off Verification.

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	√
Warehouse	x	√
General	x	x
Maintenance	x	√