Quality Assurance in Pharma: Procedure for issuing the change control.

1.0. OBJECTIVE:

To lay down a standard procedure to be followed for any changes from the existing validated manufacturing/packing procedures/methods, Specification, Method of Analysis. This is to ensure that the changes have no adverse impact on quality, safety, efficacy of the product and related documents changed appropriately.

2.0. SCOPE:

This procedure is applicable at company-location

3.0. RESPONSIBILITY:

3.1. Respective department Officer / Executive / Manager shall be responsible to inform QA for any change / cancellation / alternate regarding to Facility / System / Process / Procedure / Document by Change Control Form.

3.2. Officer / Executive -QA shall be responsible to allot Change Control Reference No., give comments and forwarded to other department for their comments regarding the change.

4.0. PROCEDURE:

4.1. Definition :

4.1.1. A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.

4.1.2. A process that ensures that changes to materials, methods; equipment and software are properly documented, validated, approved and traceable.

4.1.3. Revalidation should be performed following a change that could have an effect on the process, procedure, quality of the product and/or the product characteristics. Revalidation should be considered as part of the change control procedure.

4.2. Changes should be controlled in accordance with a SOP as changes may have an impact on a qualified utility, system or piece of equipment, and a validated process and/or procedure.

4.3. The procedure should describe the actions to be taken, including the need for and extent of qualification or validation to be done.

4.4. Changes should be formally requested, documented and approved before implementation. Records should be maintained.

4.5. Raising of Change Control :

4.5.1. Any personnel want to change / cancellation / alternate the system / facility / equipment / procedure / method / process, they must be required to inform and approval from QA for the change / cancellation / alternate through Change Control Form (Annex-I).

4.5.2. Requisite shall be filling Annex-I in proper manner and forwarded to their HOD for comments on the change / cancellation / alternate.

4.5.3. Then he / she should be forwarded the change control form to QA department for further process and approval.

4.6. Numbering System of Chang Control and Documentation :

4.6.1. On receiving the Change Control Form (Annex-I), QA will make a necessary entry in the Change Control Register (Annex-II).

4.6.2. Then he / she should be allot a number to the change control as follows:

4.6.2.1.‘CCP/AAA/YY/ZZZ’

- Here AAA stands for type of Document / system / process / method /equipment / Facility as described in following table:

Type of Document / System / Facility / Process / Method	Allotted Code No.
Standard Operating Procedure	SOP
Specification (Standard testing procedure, General testing procedure, Analytical work record)	SPC
Site Master File	SMF
Validation Master Plan	VMP
Quality Management System (Quality Manual)	QMS
Master Formula Card for Manufacturing	MCF
Master Formula Card for Packing	MCP
Batch Manufacturing Record	BMR
Batch Packing Record	BPR
Facility	FCT
System	SYS

- Here YY stands for last two digits of current year i.e. for 2012 it should be 12.

- Here ZZZ stands for sequential number in three digits i.e. 001, 002, 003 …

4.7. Assessment of Proposed Change :

4.7.1. After making entry in to the register and number to the CCP, QA will forward the CCP to the affected various department head for their comments and acceptance / rejection.

4.8. Change Control Pre-approval / Corrective and Preventive Actions :

4.8.1. After collection of the comments from various departments the CCP will be forwarded to QA Head for their Acceptance, comments, corrective and preventive action.

4.8.2. After pre-approval from QA Head, QA Officer / Executive will intimate for acceptance of change control to the requisite department by giving a photocopy or verbally.

4.9. Change Implementation :

4.9.1. After getting information about change control acceptance from QA, requisite shall implement the change and arrange training session if required.

4.9.2. Requisite department head shall take an action plan as described in CCP.

4.10. Change Control Post Approval :

4.10.1. After implement the change, QA Head will monitor the affect, impact of change on the quality and after getting satisfied, QA Head will approve the CCP.

4.11. Change Control Close :

4.11.1. After approval the CCP, QA Officer / Executive will make a necessary entry in to the CCP register (Annex-II).

4.11.2. He / she shall make status of CCP i.e. acceptance or rejected with sign and date.

4.12. Flow chart of Change Control is described in Annex-III.

5.0. ANNEXURE:

Annexure-I : Change Control Form

Annexure-II : Change Control register

Annexure-III : Flow Chart for Change Control

6.0. REFERENCES : Nil

7.0. ABBREVIATION:

Abbreviation used Full form of abbreviation used

QAD Quality Assurance

No. Number

SOP Standard Operating Procedure

CCP Change Control Proposal

8.0. DISTRIBUTED TO:

Quality Assurance Department

Quality Control Department

Warehouse Department

Engineering Department

Human Resource & Administration Department

Manufacturing Department

9.0. REVISION HISTORY:

Revision	Change Control No.	Reason for the Modifications

Annx- 1 Change control form

A. Change Initiation

Originating Department:

Date:

TO BE FILLED BY Q.A

CCP No:

Category : Major , Moderate , Minor

Q.A. Sign/Date :

* Present Status:

* Proposed Change:

* Justification For Change (provide the reason and rationale for the proposed change):

Change Related To :

New Product Introduction	Manufacturing Formula/Process	Sop
STP/GTP	Specification	Batch size
Shelf Life	In process control parameter	Raw Material
Packaging material	Vendor	Equipment