Types and Procedure of Change Control

1. The initiating department shall initiate the change as per the change control format no.
2. The initiating department shall furnish the details very clearly in the form of present process/use, proposed change, Justification & impact analysis and acceptance criteria.
3. The initiating department shall also define changes as major or minor based on product quality or its impact on safety, health and environmental aspects. Some of the major and minor changes are listed below: -
3.1 Major Changes
For a substance of chemical and microbiological quality evaluation.
• Addition or deletion of a step or addition of an alternative/new step in the formulation manufacturing process.
• Addition of a new manufacturing site with modification of the formulation manufacturing process described in the original dossier/document.
• Change in input quantities of formulation manufacturing process.
• Changes in the quality of raw material(s) or key intermediate(s) used in the formulation manufacturing process.

3.2 Minor Changes
• Change in the administrative references (name/company name, address) of the certificate holder.
• Change in the references (name/company name, address) of the manufacturing site.
• Change or updating of the methods of analysis used to test the substance.
• Change in the specifications of the substance.
• Change in the supplier of starting and packing material.
• Change in the batch size.
• Addition of a new manufacturing site in the same site as described in the original dossier.
• Change in the documents like SOPs etc.
4. The Initiating department shall forward the proposal as per the requirement to Formulation & Development Department for comments and clearance.
5. After giving comments/clearance, Formulation & Development shall forward the change control form to Quality assurance department.
6. On receipt of Change control form from F & D department, QA shall assign the Change control number as per the procedure is given below:
Assigning a change control number
- Each change control number contains seven digits.
- First two digits represent change control code.
- Third, fourth and fifth digit represent sequential change control No. (001 to 999)
- Sixth and seventh digit represents last two digits of the current year. (e.g.01, 02, 03…...99).
For example, following change control no is decoded as explained.
CC-001/ 18.
CC = Change control code.
001= Sequential Change control Number (001, 002, 003…………..999).
18= Current year 2018 (Last two digit of current year)
7. QA shall enter the details of Change in the Change control register.
8. QA shall evaluate the feasibility of the change and forward the change control form to Regulatory affairs, if required.
9. Regulatory affairs shall evaluate the change in terms of any need to inform the customer or any updation in dossiers etc. and forward the change to Site Quality Head.
10. Site Quality Head shall receive the comment from all the concerns and takes the decision of approving or rejecting the change.
11. On completion of the total procedure, QA shall formally enter the status in Change control Register and close the Change Control Procedure.
12. Put the stamp of ‘ OBSOLETE COPY’ on the old documents, where every this change control procedure is applicable.

Annexure-1

Change Control Form

1.	Initiating Dept
	Change Control No.
	Stage/Document
	Manufacturing Date
	Implementation Date
2.	Present Process/Use*	Modification: Major/Minor
3.	Proposed Process/Use*
4.	Justification/Impact of Change*
5.	Supporting Data(If Required)	Enclosed/Not Enclosed
6.	Accepted Crieteria
7.	Signature: ________________                          ___________________                        (Officer/Executive/Designee)            (Head – Initiating Department)                    Date: _________________                         ____________________

8.	Comments from F&D Department*(if required)
				Modification:	Major/Minor
				Date:
	Signature	Manager-F&D
9.	Comments from Quality Assurance Department*
				Modification:	Major/Minor
	Regulatory Notification / approval			Required / Not Required
	Type of analysis to be carried out (if any extra analysis is required, give details):
	Subsequent Stages	Will be controlled/Not controlled
	Validation Status	Will affected / not affected
				Date:
	Signature	Manager - QA
10.	Comments from Regulatory Affairs Department*(if required)
	Proposed Change is recommended/ Not recommended
				Date:
	Signature	Manager – RA
11.	Comments from Engineering Department* (If required)
				Date:
	Signature	Manager - Engineering
12.	Comments
	Authorised / Not authorised
				Date:
	Signature:     Plant Head		Site Quality Head
*Whenever applicable, append supporting documentation.

                                                                      

Change Control Record

S.No.	Date	Change Control no.	Originating Dept	Product / Document	Stage	Details of Change	Date of Implementation	Status	Remarks

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