Provide Instruction For Change Control Procedure 

1.0  OBJECTIVE:

To lay down the documented procedure for change control procedure.

2.0  SCOPE:

This SOP shall be applicable for change control procedure.

3.0  RESPONSIBILITY:

3.1  Officer/ Supervisor of respective department.

4.0  ACCOUNTABILITY:

4.1  Overall: Respective Department Head.

5.0  PROCEDURE:

5.1  Components of change control:

5.1.1        Following changes are including in-charge control procedure.

5.1.1.1  Change in the storage condition of raw material, finished goods, WIP.

5.1.1.2  Change in expiry or retest date.

5.1.1.3  Change in stability study protocol.

5.1.1.4  Change in SOP.

5.1.1.5  Change in protocol.

5.1.1.6  Change in batch manufacturing record.

5.1.1.7  Change in batch packing record.

5.1.2        Change in specification and analytical test method of following:

5.1.2.1  Raw materials and packaging materials.

5.1.2.2  In-process and intermediates.

5.1.2.3  Finished products.

5.1.2.4  Change in drawings.

5.1.2.5  Change in utilities.

5.1.2.6  Change in manufacturing process including rework and re-processing.

5.1.2.7  In-process controls.

 

 

5.2  Change control procedure:

5.2.1        Any of the change excluding the changes in specifications, analytical methods, master formula, match manufacturing records and those changes affecting the regulatory affairs shall be controlled by the corporate Q.A.

5.2.2        Any changes at related to GMP requirements but not directly related to manufacturing or testing process shall be controlled through Q.A.

5.2.3        The person requesting the change should fill in the ‘Change Control Form’ and submit it to Q.A In-charge through the department head.

5.2.4        The person requesting the changes shall add any reasons or justification with adequate supporting data for the change to the ‘Change Control Form’.

5.2.5        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.

5.2.6        The Q.A In-charge shall verify the proposed change by a number of factors.

5.2.7        If required the Q.A In-charge shall direct the changes to corporate Q.A.

5.2.8        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.

5.2.9        The Q.A In-charge shall approve the change and shall forward the request to corporate Q.A for their evaluation & suggestions if required.

5.2.10    If proposed change is in the preview of corporate Q.A, the Q.A In-charge shall forward the change control form with his/ her remark or suggestions to the corporate Q.A. Q.A personnel shall coordinate with corporate Q.A for the proposed change.

5.2.11    Once the Q.A department approves the change control form, the user department shall prepare relevant revised documents.

5.2.12    The revised document shall be approved by Q.A In-charge.

5.2.13    User department shall implement the change, based on effective date mentioned on the documents.

5.3  Note:

5.3.1        For any proposed change it is necessary to confirm that, the proposed change will not violet the statutory requirements. If it is require informing 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  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

Annexure 1: Log Book for Change Control.

 Annexure: 1

Log Book for Change Control

Change Control Form

Sr. #

Change control no.

Document no.

Revision no.

Description of change reason for change

Effective date

Signature of Q.A

remarks

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

SOP

Standard operating procedure

&

And

No.

Number  

Ltd.

Limited

QA

Quality assurance

F

Format

GMP

Good manufacturing practice

WIP

 Work in process

 


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