04 -CHANGE CONTROL

Department:

CC No.:

Product: (If applicable)

Date of Initiation:

Change Control Logged:           Yes / No

Date of Implementation:

A. CHANGE INITIATION:

A.1. Existing Position

A.2. Proposed Change (s): Description of change proposed with reference of document where this change will be applicable

A.3.     Reason for proposing the change (s) :

A.4.Basis / Reference of the proposed change (s) :

A.5. Tentative Date of Implementation (Batch No, if applicable): Batch No.   ______________________________    Date   : __________________

Change (s) Initiated By Name :  ________________________________    Sign/Date____________________

Initiating Department Head Name :  ______________________________ Sign/Date____________________

A.6.Attachments with proposed change (s)  (Attach separate sheet, if required)             1.             2.             3.

B.   Evaluation of Proposed Change:         Classification of Change:   MINOR                        MAJOR        B.1.    Document to be revised / updated / information to be furnished

Document *

Yes/No. **

Document

Existing reference No.

Revised reference No.

Remarks

BPCR / Batch Formula / Master          manufacturing Instruction /SOP/ Formats

Specification (s) / Test Procedures

Validation Master Plan/Validation Protocol / Validation

Documentation Format/Test Data sheets

Stability Protocol

Drawing (s), Utility Drawings, lay outs etc.

Technical Agreement with the customers / supplier

Marketing Authorization Application

Site Master File

Any Other (Specify)

*      Strike out which ever not applicable **    Write yes or No or NA (not applicable)

B.2.   Action Plan for the proposed change

Action /Requirement

Detail

Training Requirement

Validation Trial/ Exhibit Batch. Specify the Batch Number of Exhibit batch(s)

Qualification (DQ / IQ / OQ / PQ)

Stability Study (Specify Batch No & Storage conditions)

Information / Business Partner / key customer (s) /Internal information to other Departments

Validation of analytical procedure

Vendor Qualification

BSE / TSE Certification Requirement (In case of change in the source of Raw Material)

Area need to be evaluated / Risk Analysis / Any Other (Specify)

B. 3.     Proposed change (s) evaluated by (as applicable):

Name

Sign

Date

Comments

Engineering / Project

Manufacturing

Quality Control

Head R&D

Regulatory

Stores

Plant Head

Quality Assurance

Head – QA / RA

Write N/A (If not Applicable)

C. Change Control Approval

Proposed Change may be

Approved / Rejected

Remarks: (if any)

QA Department        Name :  _______________________ Sign_____________________  Date_____________

D.  D. Evaluation of Change (Post Implementation) D1. Review of results (If applicable):

Basis

Conclusion

* Result of Validation Study/Exhibit Batch

* Result of Stability Study

* Result of trials carried out by R&D/   Process               Engineering/ Manufacturing Plant/QC

Any other data/document

* Attach separate sheet [if required] Write N/A (If Not Applicable)

D2.      Evaluation done by (as applicable)

Name

Sign

Date

Comments

Engineering / Project

Manufacturing

Quality Control

Head R&D

Regulatory

Stores

Plant Head

Quality Assurance

Head - QA / RA

(Write N/A if Not Applicable)

Final closure (Action Taken)

Document No./ Comments

Sign.

Date

Training Given

Validation Trial/ Exhibit Batch. Specify the Batch Number of Exhibit batch(s)

Qualification (DQ / IQ / OQ / PQ)

Stability Study (Specify Batch No & Storage conditions)

Information / Business Partner / key customer (s) /Internal information to other Departments

Validation / Revalidation of analytical procedure

Vendor Qualification

Validation / Revalidation of Manufacturing process

BSE / TSE Certification Requirement (In case of change in the source of Raw Material)

Area need to be evaluated / Risk Analysis / Any Other (Specify)

D3.      Evaluation and Conclusion after Implementation of Change:  (If Applicable)

Recommended for Regularization: Yes/No Document Reference(S):

Quality Assurance

(Sign/Date)