Change Control in Pharma

OBJECTIVE

- To provide the procedure to evaluate all changes that may affect the production and control of finished products and cGMP relevant systems.
To ensure representatives of appropriate disciplines review proposed changes that might affect the validated status of facilities, systems, equipment, processes, documentation and to determine the need for actions that would ensure documentation and system is maintained in a validated state and does not affect product quality, safety, Purity and efficacy and stability.
SCOPE
- This procedure covers the initiation, logging, classifications, review, impact assessment, approval and closing of all cGMP relevant changes that may affect manufacturing and control of in-process and finished products of Andhra Medi Pharma India Pvt Ltd Veeravalli.
Introduction of service, process, product, system, utilities which is expected to have impact on the current and or corresponding existing systems shall be routed through change control.
RESPONSIBILITY
- It is the responsibility of owner of the process, procedure, system, facility, Utility etc., for initiation of the change.

It is the responsibility of other relevant department’s personnel to give their comments on the change and identify affecting documents in their department and to take required actions and follow-up.

It is the responsibility of RA & marketing to assess impact of the change on regulatory filing, commitments and notification requirements and act accordingly.

It is the responsibility of designees in QA for logging, evaluation and assessing the change impact on product, System, facility, Utilities follow-up on recommended actions, approving or rejecting and closing of the change control.
ABBREVIATIONS/ DEFINITIONS
- Abbrevitions
  - SOP : Standard Operating Procedure
  - HOD : Head of the department
  - RA : Regulatory Affairs
  - cGMP : Current Good Manufacturing Practice
  - HVAC : Heating Ventilation and Air Condition
  - QA : Quality Assurance
  - Ex : Example
  - RH : Relative Humidity
  - IT : Information Technology
  - EH&S : Environmental, Health & Safety
  - MK : Marketing department.
  - PR : Purchase department.
  - API : Active Pharmaceutical Ingredient.
  - QC : Quality Control.
  - FD : Formulation research and development
  - TTD : Technology transfer department
  - AD : Analytical research and development
  - PD : Production
  - QP : Qualified person
  - PKD : Packaging development
  - SISPQ : Safety, Identity, Strength, Purity and Quality
  - SEZ : Special Economic Zone
  - ICH : International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
  - EU GMP : European Union Good Manufacturing Practices
  - TSE : Transmissible Spongiform Encephalopathy
  - BSE : Bovine Spongiform Encephalopathy
  - MPC : Master Packaging Card
  - MFC : Master Formula Card
  - TA : Technical Agreement
  - BMR : Batch Manufacturing Record
  - BPR : Batch Packaging Record
  - VMP : Validation Master Plan
  - MSDS : Material Safety Data Sheet
  - PLC : Programmable Logic Controller
- Definitions:
  - Change control – Definition

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

Change: Any planned introduction of product, equipment, facilities or utilities, any addition to, deletion of, or modification to process/procedures, materials, product or practices, new introduction to facility or premises.

PROCEDURE

Note: All proposed changes shall be routed through Management of change control system

Initiatio

Initiator

Log and Numbering

QA shall discuss with initiator and conclude

Yes

Further information required?

QA review

Not OK

QA shall evaluate the relevant departments comments and conclude for approval/rejection

Evaluation by team

OK No

Reject

QA Conclusion

Not OK

Approval for execution

Execution

Monitoring during Execution

Execution by initiator, Monitoring and review by QA

Scope expansion required?

Yes

QA Review

Revert to initial position

No Not OK

Approve and adopt change

Changes made to the following reasons but not limited to
- Regulatory requirements
- Improvements to the good manufacturing practices
- Improvement to quality attributes of finished products.
- Capacity enhancement
- Introduction of new finished products.
- Cost reduction
- Automation
- Aging of facility
- Customer and marketing requirements
- Handle unavoidable situation
Changes are associated with the following but not limited to:
- Changes in the document (SOP / Site Master File / Validation Master Plan etc.)
- Changes in the facility
- Changes to equipments / instruments
- Changes in raw materials and or manufacturing process
- Changes in specifications
- Changes in test methods
- Changes to utilities
- Changes in software and hardware
- Relocation of equipments
- Modification of existing equipments
- Changes to labeling
- Changes to packaging materials.
- Changes to manufacturing site
- Changes in vendor (APIs, excipients and Primary, secondary packing material)
- Changes in approved art works
- Change in design space, etc
CLASSIFICATION OF CHANGES

Changes are categorized into MAJOR and MINOR depending on their impact on the process and product quality.

MAJOR CHANGEYou are expectpotentially affectffect on the quality attributes (SISPQ) of Finishthe ed Product such as dissolution, Assay, purity, stability, disintegration time, particle size bioequivalency impurity profile, microbial attributes etc.
Warrants suitable revalidation, stability studies and or equivalency to justify change.
Require customer and regulatory notification.

MINOR CHANGE:
- It is is unlikely to have a detectable impact on the quality attributes (SISPQ) of tthe he finished proud,ct, such as dissolution, Assay, purity, stability, disintegration time, particle size, bio-equivalency impurity profile, microbial attribute,es, etc.

Does not require extensive validation.
Require customer notification if it is part of the quality agreement.
Require regulatory notification.

Changes in further circumstances:
- Other changes apart from above examples cited above shall also be classified as major or minor based on the affect of change on product SISPQ.

Management of change procedure is not applicable for the replacement of spares (temperature indicators, scanners), gauges (pressure, vacuum gauges), and other equipment ancillaries’ replacement with the same design (Ex: Miller dome, sifter lid, transfer lines) which are routed through work order for execution, line clearance and subjected for independent calibration as applicable.

This management of change does not apply to some mainand tenance, civil activities which are not connthe the ected to product, equipment line and which do a a not have direct or indirect impact on product quality. (Ex: Construction of roof at water generation plant, construction wall for segrrsingraisingon, raise wall height, change in directutilityilities lines) which are routed throorderssork ororderssor execution and line clearance.
INITIATION OF MANAGEMENT OF CHANGE (Section-I-Proposal for change)
- The originator shall obtain “Management of Change” ( Annexure-I) from QA.
The originating department should write all the details including proposed change(s), Existing status and reason for the change in the “Management of Change Form (Annexure-I)” and forward it to QA.
Supporting documents for the proposed change shall be attached to the form by the originator
The following are the originators of various types of changes:

S.No.	Scope of change	Owner/Originator of the Management of Change	Relevant departments from which consent is to be taken in addition to QA
1	Change in the building of • Production • Warehouse • Quality Control • Microbiology Lab • Engineering • Analytical research and development	Operating owner	EG, PD, QC
S.No.	Scope of change	Owner/Originator of the Management of Change	Relevant departments from which consent is to be taken in addition to QA
2	Change in Critical Utility System (HVAC, Water system, Compressed air, Nitrogen)	EG	PD, QC, MB, WH, AD & TTD
3	Software and Hardware	Operating owner	EG/IT/QC/PD
4	Change of product and associated equipment	PD	EG, RA & TTD
5	Change in batch size	PD, TTD	EG, WH, QC, RA, MARKETING & TTD
6	Change in production process sequence	PD	TTD & RA
7	Change in process parameters	PD	TTD & RA
8	Change in the in-process control test	PD	TTD & RA, QC
9	Change in the Manufacturing process	PD	TTD & RA, QC, WH, EG, MK
10	Change in product specification	QC	PD, TTD, RA & QC
11	Change in material specifications	QC	PD, TTD, RA, PR, AD, QC & MB
12	Change in API/ excipients/critical raw material/ primary, secondary packing material/Printed packaging material source	PD/WH/PKD	TTD, RA, PR, QC, PD&MK

QA shall assign a number as below and log it in the “Management of Change Log” (Annexure-III).

Structure of Number: ABC/CCF/DDD/YY/NN

Where

ABC indicates The Name of company

CCF indicates Change Control Form

DDD indicates (2-3 letters) product code and for general given as GEN.

YY indicatesthe last two digits of the calendar year in which change is requested

It indicates serial number of change

Example: a) AMP/CCF/GEN/18/001

1^St Management of change which is related to general at ABC in the year 2018

b) ABC/CCF/AH/18/001

1^St Management of change which is related to Amine HCl at ABC in the year 2018

Note: Any change is not product specific such as facility modification, utilities, and common systems for all products etc. should be substituted by code “GEN” in place of product code

Section-II (Assessment of impact of change) After assigning the number, QA shall review as per “Management of Change assessment form (Annexure-I)” and assessment done by cross functional team for any additional information then call the associated department’s personnel (HOD or his designee) including with RA/Marketing/Purchase by teleconference for the actions to be taken relevant to the change.

Section-Ill: (Approval of Proposed change) Based on the discussions, conclusions shall be documented by QA in “Management of Change Assessment form (Annexur-I)” for approval or rejection of change execution.

Acceptance for approval/rejection shall be taken from available participants. Electronic acceptance (email) shall be filed with CCF from personnel who participated in telephonic/video conference.

Based on the conclusion, pre execution, during execution and post execution requirements shall be documented in “Management of Change Assessment form (Annexure-I)” by referring the format “Management of change activities to be performed (Annexure-IV)” as a guidelines copy for assessment and mention relevant document number as applicable.

Based on the change assessment, risk analysis requirements shall also be considered
QA shall send the copy of “Management of Change form” to the user department and other related departments as a reference copy to use as guide during the execution phase.
The list of activities to be performed should be taken from the format Annexure-IV, other than the activities present in the Annexure-IV shall be consider based on the proposed change and based on the recommendation of other departments heads as per the assessment on proposed change.
In case of changes in facility, copies of finalized drawings shall be displayed at respective place.
Originator shall implement the changes as proposed and shall co-ordinate with relevant department’s personnel for completion of all the relevant activities, mentioned in the “Management of Change form (Annexure-I)” along with activity sheet
In case of any scope expansion with respect to proposed change it shall be routed through “Management of Change – Scope Expansion / Change Form (Annexure-II)” as per below procedure:
Originator shall raise the “Management of Change – Scope Expansion / Change Form (Annexure-II)” to QA mentioned with expansion of the scope.
QA personnel shall call relevant department’s personnel for “Minutes of Meeting” on about expansion of the scope.
Based on the “Management of Change Assessment Form”, QA shall write relevant actions to be taken with respect to expanded scope in “Management of Change – Scope Expansion / Change Form ( Annexure-II)”. Relevant department’s personnel shall give their opinions, comments & approval on about recommended actions with respect to increasing scope.
Based on the comments & approvals of relevant department’s personnel, QA shall approve/reject the expansion of the scope.
After approval by QA, proposed scope expansion shall be implemented and “Management of Change – Scope Expansion / Change Form (Annexure-II)” shall be attached with respective “Management of Change Form” along with activity sheet.
Section-IV:(Implementation of change) After the completion of proposed change & all relevant activities which ever mentioned in the “Management of Change form ( Annexure-I )”and “Management of Change – Scope Expansion / Change Form (Annexure-II)” originator shall submit the relevant revised documents to QA as per the assessment.
QA shall review & approve the modified procedure/documents according to the actions mentioned in the Assessment Form, “Management of Change – Scope Expansion / Change Form (Annexure-II)”. If applicable in case of any abnormalities found during review QA shall intimate to originator to get the accurate conclusion.
The personnel who were involved in all the relevant activities with respect to proposed changes shall be trained by their superiors on about modified documents/process.
If change requires prior-approval from regulatory bodies or customers or QP the same shall be implemented after obtaining the approval. QA shall further review documentation changes, actions taken for change execution based on the feedback from regulatory or customers.
Major changes should be notified to the customers. Change notification to the customers/ regulatory authorities shall be fulfilled through format “Management of change- Customer / Regulatory Notification Form (Annexure-V)”
If change requires regulatory or customer notifications, the same will be done by RA/Marketing Department. Change notification form shall send to RA/Marketing by QA

Note: Irrespective of internal change classification, if any change requires customer/ regulatory notification as per RA assessment in accordance with respective country regulations, the same shall be fulfilled

As per internal classification, if any change does not call for notification to customer/ regulatory authority as per specific country regulations or customer quality agreement, the same shall be justified in change control.

QA shall also ensure that all controlled Copies of earlier version are destroyed and Master document is stamped with “OBSOLETE” and filed with QA archival.
QA department is responsible to review the change in terms of equivalency study, validation and stability etc as applicable.
Section -V (Post Implementation review and Closure of change control form): Based on the outcome of change review QA shall conclude the change control as approved or rejected and close the same through “Management of Change Form ( Annexure-I)” and Management of change log by mentioning whether the change is approved or rejected, closing date, remarks (if any) and sign it.
If the change is rejected, appropriate actions shall be considered either go with existing one / further optimization
Proposed changes should be implemented and respective management of change shall be closed within 45 working days for general change controls and product or facility/Utility related change controls shall be closed within 6 months from the date of initiation.
For site variations and after manufacturing of two batches of new products or validation batches and third batch is not yet planned within the closure period change control can be closed by mentioning the proper reason.
Periodic review of change controls will be done by trained personnel and follow up action is required for closure. Change controls will review first week of every month for status of change controls which are in open stage and post implementation requirements, for closed change controls and the status will be updated in the format Review and updation status of change control (Annexure-VII).
Any delay for the closing the change control within the timelines will be justified as per for the Format Annexure-VI.
Trending of Change Controls:
- Trends for the General and Product specific change controls should be prepared by including the number of changes initiated during the period and reason for change along with the summary and conclusion on the changes.

ANNEXURES
- Annexure-I : Management of Change Form
- Annexure-II: Management of Change – scope expansion / change form
- Annexure-III :Management of Change log
- Annexure-IV :Management of Change Evaluation-List of activities as a guideline copy to be performed
- Annexure-V: Management of Change- Customer/Regulatory notification form
- Annexure-VI: Justification note for delay in closing of management of change
- Annexure-VII Review and updation status of change control

Annexure-I

MANAGEMENT OF CHANGE FORM

Header:

Logo	COMPANY NAME
Title: MANAGEMENT OF CHANGE FORM
CCF No.:		Page No:

	SECTION -I: Proposal For Change			CCF No.:
QA	Date of CCF logging: –/—/—– (DD/MM/YYYY)			Date of CCF Closing:—-/—–/——– (DD/MM/YYYY)
User Dept. User Dept.	Initiating Department:	Date of initiation: —–/—-/—–(DD/MM/YYYY)
	Changes Required in þ Document þ Facility þ Equipment þ Test Method þ Utility þ Process þ Software/Hardware þ Packaging þ Labeling þ Vendor(RM/PM) þ New Product þ Others………………………………………………………………………………………….
	Details of Product / Document / system / facility/Others :
	Document Number along with version number /Code Number (If applicable) :
	Description of Change required : [attach separate pages if required]
	Proposed Change:
	Existing status:
	Reason for change:
	Initiator (Sign & Date):			User Dept.Head (Sign & Date):
User Dept and QA	Section II: Assessment of impact of change
	Tick mark “ü” if applicable and “X” mark if not applicable
	Impacted Document		Applicable		Justification if not done/Remarks
	SOP		□
	Training		□
	SAP ( Item code for RM/PM/IP)		□
	Specification (RM/PM/IP/CP)		□
	STP/ATDS		□
	MFC		□
	BMR		□
	MPC		□
	BPR		□
	Process flow chart		□
	Process/ Packing validation		□
	Hold		□
	Time study		□
	Process validation protocol and report		□
	Packing validation protocol and report		□
	Equipment No/Equipment list		□
	Qualification/ Requalification ( Equipment, area and system (soft ware/hard ware)/Facility/Utility)		□
	Calibration Schedule		□
	Risk Assessment		□
	Layouts		□
	Site master file		□
	Art works		□
	Validation master Plan(VMP) Annexures		□
	Stability studies		□
	Vendor Qualification		□
	Approved Vendor List		□
	Surface area of equipment		□
	MLT Validation		□
	TA from Customer		□
	EMP schedule		□
	Water Validation schedule		□
	Filter cleaning schedule		□
	Procurement of Sieves, screens, accessories, finger bags, punches and dies, scoops, sampling thief and Sampling dies etc		□
	AMT/AMV/Analytical Method Verification		□
	Cleaning method validation/Recovery		□
	API Comparison of analytical data with vendor COA		□
	Photo stability		□
	Mfg.Lic/NOC/Free sale certificate		□
	WS Qualification /RS/Impurity, reagents etc		□
	Others		□
			□
			□
			□

QA	Proposed Methodology for Implementation:
	Criteria for evaluation of the change (If applicable) :
	Category of Change: Major / Minor	Type of Change: New / Updation / Deletion
	QA (Sign & Date):

User and QA	SECTION II: Assessment of Impact of change					CCF number:
	Impact of Change on: Document/ System / Facility/ Product/ Vendor / Instrument /Equipment / Software/ Hard ware
	S.No	Related Document if (Applicable)		Impact analysis done by QA & Date	Responsibility Assigned to and Target date of Completion ( Department and Person name)		Revision Doc. No. Including version No.( If any)	Implementation Date	Remarks
	S.No	Document Name / Activities to be Performed	Document No. including Version No. if any	Impact analysis done by QA & Date







Verified By Quality Assurance ( sign & date):

CCF No.:

Evaluated By QA:

Sign & Date

Name:

Acceptance by relevant department’s personnel on proposed actions: (QA can Strike out any department if found not applicable or not relevant to the change)
Department	Comments	Conclusion circle /Strike off	Sign & Date
Production		Accepted / Not Accepted
Quality control		Accepted / Not Accepted
Warehouse		Accepted / Not Accepted
Engineering		Accepted / Not Accepted
R&D		Accepted / Not Accepted
AR&D		Accepted / Not Accepted
Packaging Development		Accepted / Not Accepted
Purchase		Accepted / Not Accepted
HR		Accepted / Not Accepted

CCF No.:
TT		Accepted / Not Accepted
Regulatory Affairs		Accepted / Not Accepted
Plant Head		Accepted / Not Accepted
Marketing		Accepted / Not Accepted
Qualified Person		Accepted / Not Accepted
Others		Accepted / Not Accepted
Tentative Close Out Date :
SECTION-III: APPROVAL OF PROPOSED CHANGE

QA Head/designee

Final Comments ( If any), Sign & Date ( Approved /Rejected )

Name:

SECTION-IV: IMPLEMENTATION OF CHANGE
Existing document withdrawn and made obsolete	YES □ NO □
Revised Document Number
Training imparted to concerned identified employees	YES □ NO □
Effective Batch Number (if applicable )
Effective Date
Other (if any )
Verified By QA ( Sign & Date )

CCF No.:

SECTION-V : Post Implementation Review and Closure of Change Control Form

Evaluation ( By Quality Assurance ) :

Complete change control Document Received and Reviewed YES □ NO □

Comments (if any )

Verified By QA ( Sign & Date )

Acceptance by relevant department’s personnel on proposed changes: (QA can Strike out any department if found not applicable or not relevant to the change)
Department	Comments	Conclusion Circle and Strike off	Sign & Date
Production		Accepted / Not Accepted
RD		Accepted / Not Accepted
ARD		Accepted / Not Accepted
Packaging Development		Accepted / Not Accepted
Quality Control		Accepted / Not Accepted
Engineering		Accepted / Not Accepted
Regulatory Affairs		Accepted / Not Accepted
Warehouse		Accepted / Not Accepted

Acceptance by relevant department’s personnel on proposed changes: (QA can Strike out any department if found not applicable or not relevant to the change)
Department	Comments	Conclusion Circle and Strike off	Sign & Date
Marketing		Accepted / Not Accepted
Purchase		Accepted / Not Accepted
TT		Accepted / Not Accepted
HR		Accepted / Not Accepted
Plant Head		Accepted / Not Accepted
Qualified Person		Accepted / Not Accepted
Others		Accepted / Not Accepted

Attachments( if any)

Final Comments and Conclusion from QA Head/Designee.

Change is Completed and Approved for Closure Yes / No

If No Specify:

Final Comments with sign and date:

Annexure-II

MANAGEMENT OF CHANGE – SCOPE EXPANSION / CHANGE FORM

Header:

Logo	COMPANY NAME
Title: CHANGE CONTROL MANAGEMENT- SCOPE EXPANSION / CHANGE FORM		Page No: x

Management of change number:___________________________________

1.Description of scope Expansion of change.

2.Justification for change: ( Attach additional sheets if required)

Originator		Quality Assurance
Initiator Sign & Date	Department HOD Sign & Date	Sign & Date
Name:	Name:	Name:

Management of Change number:___________________________________

3.Actions to be taken

As per Annexure-IV is to be reviewed and the identified tasks to be included in the section II in the format of change Annexure-I person during meeting in consultation with others present.
Any additional Activities that were not part of the attached checklist that are to be identified by QA person and recorded.

Conclusion of the Scope Expansion Form:

Change is required to be reclassified : YES/ NO
What is the new or unchanged classification : MAJOR / MINOR
Change in scope is approved for Execution : YES/ NO
If no, Is meeting required for Approval : YES/NO
If no, state the requirements to be fulfilled before approval for execution

Intermittent evaluation required: YES / NO
If yes periodicity

QA-HEAD or Designee

Final Comments, Sign & Date

Name:

Annexure-III

MANAGEMENT OF CHANGE LOG

S. No	Date	Management of Change number	Dept.	Description of change	Sign	Change approved / rejected	Major/ Minor	Closing date	Sign & Date	Remarks

Annexure-IV

Management of Change Evaluation-List of activities as a guideline copy

Header:

LOGO	COMPANY NAME
Title: Change Control Management-List of activities (as a guideline copy)		Page No:

S.No	Action to be taken
1.	Training
2.	Preparation of New SOP
3.	Revision of Existing SOP
4.	Preparation of New specification, STP, RTDS, ATDS
5.	Revision of Existing specification, STP, RTDS
6.	Preparation of New BMR & Master Formula
7.	Revision of Existing BMR & Master Formula
8.	Process Validation
9.	Partial Process Validation – Additional Testing Only
10.	Cleaning verification
11.	Blending validation/ compression validation /Coating validation
12.	Technical agreement from customer/External party
13.	Cleaning validation
14.	Modification of existing cleaning limits of an Area/Equipment
15.	Customer – Information to be given
16.	Customer – Prior Approval to be Obtained
17.	Vendor Qualification – Audit
S.No	Action to be taken
18.	Vendor Qualification – Questionnaire
19.	Vendor Qualification – Declarations (TSE/BSE, etc.)
20.	Vendor Qualification – batch sample(s) analysis
21.	Vendor Qualification – batch sample(s) use test
22.	Vendor Qualification – Technical or Quality Agreement
23.	Vendor Qualification – Letter of Undertaking for information of any major changes
24.	Regulatory Agency – Information to be given
25.	Regulatory Agency – Prior Approval to be obtained
26.	Qualification – Equipment / Utility /system (Software/Hardware)/PLC validation
27.	Qualification/Requalification — Area / Facility
28.	Equipment Equivalency
29.	Equipment Suitability
30.	Calibration of Std. Weights
31.	Process Equivalency – 3 consecutive batches
32.	Process Equivalency – 2 consecutive batches
33.	Process Equivalency – 1 consecutive batches
34.	Layout
35.	Drawing of Equipment, surface area of equipment
36.	Drawing of Entire Plant
37.	Analytical Method Validation
38.	Analytical Method Verification
39.	Analytical Cleaning Method Validation
40.	Analytical Method Transfer
41.	Drug Master File – Amendment

S.No	Action to be taken
42.	Drug Master File – New
43.	Process Equivalency – Comparison of Impurity Profile
44.	FD performance study
45.	Past Results Trend
46.	Stability study – 3 batches at long-term, intermediate and accelerated conditions
47.	Stability study – 3 batches at long-term and accelerated conditions
48.	Stability study – 1 batch at long-term condition
49.	Stability study – 1 batch at accelerated condition
50.	Hold time Study
51.	Revision in Site Master File
52.	Revision in Validation Master Plan
53.	Vendor Qualification – Shelf life Declaration
54.	Facility Changes
55.	Approval of Local Drug Control Authority
56.	Approval or Submission of Changes to Excise Department, SEZ
57.	Consent from Pollution Control Board
58.	Intimation to Inspector of Factories
59.	Label Contents Change
60.	Characterization study
61.	Forced Degradation study
62.	Photo Stability study
63.	Line Clearance
64.	Pest and Rodent Control Requirement to be changed
65.	Fire Extinguishers Requirement to be assessed

S.No	Action to be taken
66.	Review on Safety Procedures
67.	Revision in Preventive Maintenance Schedule
68.	Revision in Calibration Schedule
69.	Working Standard Qualification
70.	Reference Standard Qualification
71.	Revision in Stability Specifications
72.	Revision of Retest Period / Expiry Date
73.	Column Equivalency Study
74.	Trial / Evaluation Batch is Required
75.	Microbial Monitoring of Air
76.	Software Validation
77.	Hard ware Validation
78.	Temperature Mapping
79.	Product Development Report
80.	Product Development Report – Addendum
81.	Risk-Assessment To evaluate the affect of Parameter on quality of product or quality of systems. Risk-Assessment of an equipment Risk-Assessment to evaluate the affect of the change in packaging material / storage conditions Hazard and Operability Study is to be prepared / modified
82.	Product list
83.	List of equipments
84.	VMP Annexure
85.	New / Change in MSDS
86.	New / Renewal of License with Explosives Department
87.	Requalification of Utilities
S.No	Action to be taken
88.	Requalification of Equipment
89.	HVAC Validation
90.	Purified water validation
91.	Stress study
92.	Change in storage condition
93.	Notify to Qualify Person( QP)
94.	Guidelines Copy
95.	Cleaning validation recovery
96.	Temperature excursion study
97.	Freeze thaw study
98.	Revision of cleaning of filters schedule
99.	HVAC Qualification
100.	Water system qualification

Annexure-V

Change Control Management – Customer / Regulatory Notification Form

Header:

LOGO

COMPANY NAME

Title: Change Control Management – Customer / Regulatory Notification Form

Page No: 1 of 1

Management of Chane number ____________________________

Product Name:

Description of Proposed change:

Customer notification requirement identified	:	Yes/No
Regulatory notification requirement identified	:	Yes/No
QA Designate Sign/Date	:

To be filled by Regulatory Affairs/ Marketing Department

S.No.	Name of the Customer / Regulatory Authority to be informed	Informed on	Approved on	Customer / Regulatory authority sign and date

Use additional sheets if required

Regulatory Affairs/ Marketing Designate sign/Date	:
Received by QA Designate sign/Date	:

Note: Relevant evidence to be sent along with filled document

Justification Note For Delay In Closing Of Management Of Change

Logo

COMPANY NAME

Title: Justification Note For Delay In Closing Of Management Of Change

Page No: 1 of 1

Initiating Department Change Control Number

Date of the Approval

_______________________________________________________________________________

Justification for Delay

___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Next Tentative Date of Implementation

Department-Head

( Signature / Date)

QA (Remarks) ____________________________________________________________________________________________________________________________________________________________

Annexure-VII

Review and updation status of change control

Header:

Logo

Title: Review and updation status of change control

Page No: 1 of 1

Product Name/General:

Management of change number:

Description of change:

S.No	Date	Updation Status	Pending Status	Updated by user dept head/designee	Checked by QA head/designee

REVISION SUMMARY

S. No	SOP No.	Effective date
1	ABC/QA/SOP/00X	XX-YY-ZZZZ

END OF THE DOCUMENT

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