Friday, November 19, 2010

Procedure Change Control

1.0 Purpose : To provide instruction for change control procedure.

2.0 Objective : To provide a documented procedure for change control procedure.

3.0 Scope : This procedure is applicable for change control procedure.

4.0 Responsibility :
Primary: Officer / Supervisor of respective department.
Overall: Respective department Head.

5.0 Procedure :
• Components of change control
 Following changes are including in change control procedure.
 Change in the storage condition of raw material, finished goods, WIP.
 Change in Expiry or retest date.
 Change in Stability study protocol.
 Change in SOP.
 Change in protocol.
 Change in Batch Manufacturing Record.
 Change in Batch Packing Record.
 Change in Specification and Analytical Test Method of following:
 Raw materials and Packaging materials.
 In process and Intermediates.
 Finished Products.
 Change in drawings.
 Change in Utilities.
 Change in Manufacturing process including rework and re-processing.
 In process controls.

• Change Control Procedure.
 Any of the changes excluding the changes in specifications, analytical methods, Master Formula, Batch Manufacturing Records and those changes affecting the regulatory affairs shall be controlled by the corporate QA.
 Any changes at related to GMP requirements but not directly related to manufacturing or testing process shall be controlled through Ankleshwar QA.
 The person requesting the change should fill in the ‘Change Control form’ and submit it to QA In charge through the department head.
 The person requesting the change shall add any reasons or justification with adequate supporting data for the change to the ‘Change Control form”.
 The Q. A In charge shall evaluate the change proposal considering the necessity for change and any other GMP aspects that will be affected by the proposed change. If the Q.A In charge has the valid reasons to reject the proposal for change, he / she can reject the change proposal and intimate the requester about the same.
 The Q.A In charge shall verify the proposed change by a number of factors
 If required the Q.A In charge shall direct the changes to Corporate QA
 If the supporting data is not sufficient, he / she shall direct the requester or any other related departments e.g. Quality Control to generate the specified information or data.
 The Q.A In charge shall approve the change and shall forward the request to corporate QA for their evaluation & suggestions if required.
 If proposed change is in the purview of Corporate QA, The QA In charge shall forward the change control form with his/ her remark or suggestions to the corporate QA. QA personnel shall coordinate with corporate QA for the proposed change.
 Once the QA department approves the change control form, the user department shall prepare relevant revised documents.
 The revised document shall be approved by QA in charge.
 User department shall implement the change, based on effective date mentioned on the documents.

NOTE: For any proposed change it is necessary to confirm that, the proposed change will not violet the statutory requirements. If it is require to inform to statutory authority of the concern country or to the concern buyer, it is necessary to first get approval from statutory authority of the concern country or from the buyer, than only proposed change shall be implemented.

6.0 Reference Document :
 Change Control Form
 Change Control logbook


Sr. No. Change
No. Document No. Revision No. Description of Change Reason for Change Effective date Signature of
QA Remarks

7.0 Abbreviations:
• QA = Quality Assurance department
• SOP = Standard Operating Procedure
• WIP = Work In Progress
• GMP = Good Manufacturing Practices
• CCF = Change Control Format

8.0 Copies to Distribution Sites
• QA –Ankleshwar
• QC- Ankleshwar
• Stores – Ankleshwar
• Production – Ankleshwar
• Engineering – Ankleshwar
• Personnel & Administration – Ankleshwar

9.0 Review History :

Sr. No. Previous
Revision No. New
Rev. No. Review Date Reason For
Review Change
No. Approved

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