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Change Control and New Procedure Implementation

This SOP outlines the process for controlling changes and implementing new procedures at Humanwell Pharmaceutical Ethiopia PLC. Any personnel working there are responsible for following this procedure when making changes that could affect product quality. The procedure involves defining a change request, technical review of the request by quality assurance, approval or rejection, implementation of approved changes, monitoring, and documentation. The goal is to carefully control any changes that could impact products or services.

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Solomon Gamanuel
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94 views3 pages

Change Control and New Procedure Implementation

This SOP outlines the process for controlling changes and implementing new procedures at Humanwell Pharmaceutical Ethiopia PLC. Any personnel working there are responsible for following this procedure when making changes that could affect product quality. The procedure involves defining a change request, technical review of the request by quality assurance, approval or rejection, implementation of approved changes, monitoring, and documentation. The goal is to carefully control any changes that could impact products or services.

Uploaded by

Solomon Gamanuel
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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SOP Change Control and New Procedure

Implementation

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
The purpose of this SOP is to control and changes that can possibly be made and thus
directly or indirectly affect the quality of product and services.

2. Scope

This SOP is applicable to changes made at Humanwell Pharmaceutical Ethiopia PLC


which could have effect on the quality of the product.

3. Validity

This SOP is valid up to the next revision date and only if it bears the control seal.

4. Responsibility

It is the responsibility of any personnel working at Humanwell Pharmaceutical Ethiopia


PLC to follow this procedure during implementation of changes which could affect the
quality of finished product.

5. Material and Equipment


None

6. Procedure
6.1. Person issuing the change request should define the data needed to raise the request,
reason for changes and should evaluate the impact and/or consequences of changes and
define the part responsible to carry out the change by filling change/Implementation
proposal format.
6.2. The raised request is then submitted to the Quality assurance manager.
6.3. The QA manger then reviews the changes request form and based on the submitted
document he/she may decide the one following
 Request further technical review
 Approve the requested change
 Reject the change request
 Suspend the change request
6.4. Technical review:- If the case requires further impact assessment, the Quality
assurance manager initiates further review on the impact and assign a technical
personnel that assess the impact of the changes approve/ rejection and suspension of the
change request
6.5. Based on the impact assessment from technical personnel review, the Quality
assurance Manager fills the result of the on the change request format
6.6. Based on the comment and total assessment result, the Quality assurance Manager
approves the requested change
6.7. Following approval of the request, the requesting party will carry out as per the
request
6.8. If the impact assessment shows problem with the critical parameters with regard to
the product, the QA manager rejects the request
6.9. After change is initiated, it shall be followed and monitored for its full
implementation.
6.10. If the monitoring and follow up results are the same to the assessed impacts and
results, then the case will be closed.
6.11. All filled information shall be filled in two copies, and returned in the QA Manager
and the other to the requesting unit.
6. Abbreviations:
 SOP Standard Operating Procedure
7. Related Documents /Applicable document/
None
8. Revision History

Version
Revision Description
No.
1 New

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