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Annexure I Change Control Form

1) The document is a change control form used by XX Pharmaceuticals to document and approve proposed changes to products, processes, facilities, or systems. 2) It requires listing the existing and proposed changes, reasons for the change, impacts on quality parameters, validation, regulatory approval needs, and approval signatures from relevant departments. 3) Once approved, the form is used to document implementation of the change and subsequent impact evaluation.

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SÜMME AÇIKGÖZ
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2K views4 pages

Annexure I Change Control Form

1) The document is a change control form used by XX Pharmaceuticals to document and approve proposed changes to products, processes, facilities, or systems. 2) It requires listing the existing and proposed changes, reasons for the change, impacts on quality parameters, validation, regulatory approval needs, and approval signatures from relevant departments. 3) Once approved, the form is used to document implementation of the change and subsequent impact evaluation.

Uploaded by

SÜMME AÇIKGÖZ
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Annexure-I

Change Control Form

Company Logo Here


XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA

Change Control Form

Change Control Initiator Originating Department &


No. (Name, Sign. & date) Area

Issued by Date of Issuance Product /material/document


name/ SOP title
(Name, Sign. &
date)

Batch No./Lab Type of Product □ Domestic


□ Export Change Type:
control no./ (Country)
□ Both □ Equipment □ Formulation
Document No. □ If Export, □ Process □ Regulatory
Country Name: □ Facility □ Utilities
□ Raw Material □Stability Protocol
□ Packing Material □ Validation
__________ □ Specification □Marketing/Sales
□ Test Method □ Any Other:
□ Batch Size
□New product introduction
□ Quality
__________

Existing System:

Description of Proposed Change :

Reason / Justification / Benefits for proposed change:

Temporary Change? □ Yes □ No Date of expiry for temporary change:

If no, justification to close the change control

Evaluated by ( Functional Head): Date:

Manager, Quality Assurance Date:

( If proposal for change is not justified):

Possible Impact

Item Recommendation Sign. of CAPA no. Status review


Impacted
dept.
head/date

Process/System
Quality Parameter

Stability:

Accelerated:40 °C / 75 % RH-3/6
month

Long term-30 °C / 65 % RH-End of


shelf life

Validation
(analytical/microbiological/cleaning
/process/filter)

Training/information

Regulatory approval/Aspect

Packing material / pack style

Health and safety

Media –fill

Qualification

Calibration

Information to Drugs / Customer

Impacts on available lots /batches

Pharmacopoeia requirements

Method of analysis

Possible Impact

Item Recommendation Sign. of CAPA no. Status review


Impacted
dept.
head/date

Container closure integrity


/Moisture permeability test/
Biological reactivity test

Master Formulation, BMR, BPR &


SOP

Retest or Expiry date

Market (□ Local □ Export)

Raw & Finished product


Specification

Information to third party required (


if require ) given by / date

Any other

Regulatory approval : Required Not required

Approved Not approved

Change review level: □ Minor □ Major □ Critical

If no, Justification to close the change control

If yes, Approval:

Functional Head or designee Sign. & date:

Quality Assurance Head or designee Sign. & date:

General Manager, Plant Sign. & date:

Manager, Quality Assurance Sign. & date:


Approval for Execution: Quality Assurance shall review the actionable mentioned in the impact analysis that is required to be in
place before implementation of proposed change.

Approved by(Manager, Quality Assurance):________________________ Date:

Change Implementation: □ Change implemented □ Change not implemented

Reason if change not implemented:

Implementation date: Effective Batch No. / A.R. No.:

Impact Evaluation:

Conclusion:

Evaluated by Quality Assurance: Sign. & date:

Change control Status:

List of impacted documents revised through this change control( To be filled by Quality compliance)

Document No. Document name Effective Batch No. / Date

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