sop for Change control

1.0 OBJECTIVE :

1.1 To lay down a procedure for initiating, reviewing, approving/rejecting,

implementing and closing the change in approved and/or validated states of quality system.

2.0. SCOPE :

2.1 This procedure is applicable to Initiation, Review and Evaluation, Approval/Rejection, Implementation and closure of change control procedure at

Pharmaceuticals Ltd . This is applicable to following but not limited to either

temporary/permanent change, new addition or discontinuation from approved

and/or validated states of quality system:
2.1.1 Manufacturing/ Master formula
2.1.2 Container and closure components
2.1.3 Manufacturing and/or packing process
2.1.4 Batch size
2.1.5 Equipment/instruments/Computer Software/PLC
2.1.6 Validated procedures e.g. cleaning, sterilization, analytical/microbial method, etc.
2.1.7 Approved documents e.g. Site master file, Validation master plans,

Standard operating/testing procedures, Specifications, Batch Record, etc.
2.1.8 Change in approved vendor/Supplier.
2.1.9 Change in Contract testing laboratory.

3.0. RESPONSIBILITY :

All employees shall responsible to ensure that no change made/implemented until the
proposed/required change is approved as per this SOP.
3.1 The Originating department manager/head shall be responsible for:
3.1.1 Requesting for the Change Control Form (CCF) to Quality Assurance (QA).
3.1.2 Forwarding the appropriately filled and justified Change Control form to QA department.
3.1.3 Implementation of proposed change after approval of change control.
3.2 Manager/Head of following departments shall be responsible for initiating

the change mentioned in scope of this procedure:

Sr. No.	Change related to	Initiating department
1.	Manufacturing formula	F&D
2.	Container and closure components	F&D , PD
3.	Manufacturing and/or packing process	F&D, PD /Production
4.	Batch size/Batch Record	Production
5.	Equipment/instruments including computer software or PLC code	Concern department/E&M department
6.	Validated procedures e.g. cleaning, sterilization, analytical/microbial method, etc	QA /QC
7.	Approved documents e.g. Site master file, Validation master plans, Standard operating/testing procedures, Specifications, BMR / BPR etc	Concern department/QA department
8.	Pharmacopoeial Changes	QC department/QA department

3.3 QA officer/executive shall be responsible for:
3.3.1 Issuing the usage copy of Change Control form.
3.3.2 Forwarding the filled Change Control form to the concern.
3.3.3 Preserving the original Change Control Form.
3.3.4 Issuing the number for CCF and Maintaining and updating the Change Control register.

3.4 The concerned department head shall be responsible to categories the

change control as per nature of change or with consultation to QA head.
3.5 Affected department manager/head shall be responsible to evaluate the

impact of proposed changes and
Recommendation, if applicable.
3.6 QA Head shall be responsible for:
3.6.1 Reviewing and recommending the change control by impact evaluation of

the proposed change on the existing validated machine, process, documents,

system and related function.
3.6.2 Reviewing and approving with recommendation of received change control

form from QA head with respect to:
3.6.2.1 Impact on safety efficacy and quality of finished product.
3.6.2.2 Consistent implementation of the proposed change at all manufacturing

facilities of Troikaa.
3.6.2.3 Requirement for intimation/approval of drug/regulatory authorities

4.0. ACCOUNTABILITY: Head QA.

5.0. PROCEDURE :
5.1. INITIATION OF CHANGE
5.1.1. Any staff member who thinks that change is necessary can initiate the

Change Control Form. But the main reason of change shall be mentioned as

below but not limited to:
5.1.1.1. To improve safety, efficacy and/or quality of finished product
5.1.1.2. To improve process output / capacity enhancement
5.1.1.3. Automation
5.1.1.4. To correct existing error
5.1.1.5. Cost reduction
5.1.1.6. Customer request
5.1.1.7. Pharmacopoeial requirement
5.1.1.8. Change of documents due to CAPA
5.1.1.9. Other (Specify if any)
5.1.2. Initiating department Officer/Executive / Managers shall request to QA Executive/Manager for issuance of ‘Change Control Form’ (Annex-I).
5.1.3. QA Officer/Executive shall allocate CCF No. in CCF as ‘1XX-CCYYZZZ’, where 1 stand for facility, ‘XX’ stands for departmental code as per SOP No. ‘CC’ stands for Change Control, ‘YY’ stands for last two digits of year and ‘ZZZ’ stands for serial no. Starts from 001 in continuation annually irrespective of department. E.g. CC09001’ is the 1st change control initiated at facility by QA department in calendar year 2009.
5.1.4. QA Officer/Executive shall write initiating department name on CCF and issue the same to initiating department. He/She also make entry in ‘Change Control Register’ (Annex-II) in each department wise for a year.
5.1.5. Initiating department Officer/Executive shall fill up the Part-I of Annex-I and give it to his/her manager/ head for review.
5.2 CATEGORY OF CHANGE:
Along with consultation of head QA, the respective department head shall categories

the change control as temporary or permanent, on the basis of nature of change,

impact of change, etc.

Change control is a formal documented process used to ensure that changes to a

product or system are introduced in a controlled and coordinated manner.

The formal documented system for reviewing and documenting proposed and

actual changes in SOP, Process and facility, which may directly or indirectly

affect the manufacturing process/quality of the product.

Temporary Change Control is a change control which is known change for a

limited time period after which the condition comes to original one. Temporary

Change Control shall be closed within 3 months, If not provide proper justification.

Permanent Change control is a change control which is a known change

control and permanent in nature.
5.3 REVIEW OF CHANGE:
5.3.1 User department Head
Initiating department manager/head shall review the form, evaluate the impact and

attach the relevant data to justify the change if needed. He/she then forward filled

Annex-I to HOD after his/her comments.
5.3.2 HOD shall approved / reject change control form. He/she then forward filled

Annex-I to QA after his/her comments
5.3.3 QA Head
QA manager/head shall review filled Part-I of Annex-I and evaluate the impact,

if required recommend the additional data/document attachment which required

to justify the change from initiating department or if found satisfactory then

QA manager/head put down the comments and sign with date on appropriate column.
5.3.4 The above change control shall be forwarded to RA for his/her review, recommendation and approval purpose (if needed, as suggested by head QA).
5.3.5 If RA comments not required, then Manager/head QA recommend to review and acknowledgement about change of concerned/affected department head and

concern shall be taken from contract parties, if necessary. The QA head shall mark

the affecting department required review and acknowledgement of

this change (on part-II of Annex-I), if necessary.
The respective department head put down the sign after review of

change and provide the comments to QA head if any.
5.3.6 QA Head shall finally approved/Not approved (give justification, if not approved) the change.
5.3.7 If QA Head does not approve proposed change, QA officer/executive shall forward the photocopy of Not approved CCF to initiating department and file the original copy year as well as department wise.
5.3.8 If proposed change is approved by QA Head, he/she shall classify the change as per below definition.
5.3.9 The following criteria are meant to provide guidance with respect to the classification of a change. Changes are classified as Level-1, Level-2 and Level-3
5.3.9.1 Level-1 change: Level-1 changes are changes that have minimal potential to have an adverse effect on the identity, strength, quality, purity or potency of the product as these factors may relate to the safety or effectiveness of the product.

5.3.9.2 Level-2 change: Level-2 changes are changes that have moderate potential to have an adverse effect on the identity, strength, quality, purity or potency of the product as these factors may relate to the safety or effectiveness of the product.
5.3.9.3 Level-3 change: Level-3 changes are that changes that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a product as these factors may relate to the safety or effectiveness of the product.
5.3.9.3.1 In general, a change that is supported by extensive documentation and require extensive assessment of the supporting documentation shall be considered as Level-3.
5.3.10 QA Head shall also assess the impact of proposed change on safety, efficacy and quality of finished product and accordingly give recommendations in Part-II of Annex-I.
5.3.11 If change is related to solid oral products, for recommendations, QA Head can refer below mentioned guidelines:
– Immediate Release Solid Oral Dosage Forms; Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. Center for Drug Evaluation and Research (CDER).
– Modified Release Solid Oral Dosage Forms; Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. Center for Drug Evaluation and Research (CDER).
5.3.12 If the proposed change is applicable to other manufacturing facilities of Troikaa, QA Head shall intimate the same through scan to QA Head of that location for implementation.
5.3.13 If the proposed change is applicable to other group of products (e.g. products with different strength, different pharmacopoieal status, different packing type/profile, etc.), QA Head shall recommend in Part-II of Annex-I accordingly.
5.3.14 QA Head shall forward the approved CCF to QA Executive for implementation and closure of change.
5.3.15 QA officer/executive shall log the required information in Annex-II.

5.4 IMPLEMENTATION AND CLOSURE OF CHANGE

5.4.1 QA officer/executive shall make photocopy of this form, distribute, and

acknowledge the receipt of photocopy from manager/head of departments as

recommended by QA Head.
5.4.2 Manager/Head of concern departments shall implement the

recommendation and ensure effectiveness(Part-III).
given by QA Head and intimate the same to QA Head.
5.4.3 QA Head shall ensure that implemented actions are verified by

QA officer/executive (Part-IV).
5.4.4 After verification, QA officer/executive shall write prepared/revised

document no. and effective date.
5.4.5 QA officer/executive shall make sign/date after verification of

all recommended actions. He/she then shall forward the CCF to QA Head.
5.4.6 QA Head shall review the verification remarks and if found satisfactory,

make sign on CCF as closure of change.
5.4.7 QA officer/executive shall forward the copy of closed CCF to

initiating department for future reference.
5.4.8 QA officer/executive shall file the. All relevant data/documents

(to justify the change) and maintain this file year as well as department wise.
5.4.9 QA officer/executive shall log the required information in Annex-II.

He/She shall maintain his register year wise.
5.4.10 Change control shall be closed out/implemented within one month

If change control not closed out/implemented within one month then provide proper justification for same.
5.4.11 Trending of change control shall be carried out as per SOP No.
6.0. ABBREVIATION :

Sr. No.	Abbreviation used	Full form of abbreviation used
1.	SOP	Standard Operating Procedure
2.	RM	Raw Material
3.	PM	Packing Material
4.	CCF	Change Control Form
5.	QA	Quality Assurance
6.	F&D	Formulation and Development department
7.	PD	Packing Development
8.	CDER	Center for Drug Evaluation and Research
9.	PLC	Programmable Logic Control
10.	QC	Quality Control

7.0 ATTACHMENTS (ANNEXES) :
Annex-I : Change Control Form
Annex-II : Change Control Register
Annex-III : Flow chart for Change Control
8.0. REFERENCE :

Good manufacturing practices and inspection, WHO

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