Standard Operating Procedure

Change Control

(Quality)

QP002

  

Version No.:

Effective Date:                                

Review Date:                                  

Supersedes:                       

Primary Author(s):

	Technical Approver	Authorized By
Name
Designation	Head of Department	Director	Quality Assurance
Signature
Date

1.            Purpose

This SOP describes the procedural requirements for proposing, documenting, approving, implementing and tracking the changes to ensure that all the changes are properly controlled and documented in a timely manner.

2.            Scope

This procedure applies to all the changes that could potentially affect:

(1)   Quality, safety and efficacy of product developed or manufactured by Fem Analytika, for the local business. 

(2)   The validation and compliance status of computer applications and systems, and software that support regulatory compliance operations.

(3)   Environmental Health and Safety (EHS) risks associated with the changes.

Examples include, not limiting to:

·         Master batch/ packaging records

·         Specifications and Test methods

·         Forms associated with SOPs and WIs

·         Stability Protocols

·         GxP Laboratory and Process equipment

·         Calibration and Maintenance (frequencies, tolerances etc)

·         Changes in the GMP facility that fundamentally alters its purpose

·         Significant organizational changes that have a potential to affect product quality, product safety, efficacy, stability

·         EHS and the validation status of processes, facilities and systems

3.            Abbreviations / Definitions

DI: Designated Individual

Originator: Individual who proposes a change

Assigned to: Individual designated to implement the approved change, if not the Originator

4.            Procedure

4.1          General

4.1.1       Changes will be proposed using the “Change Control Form” (refer to Appendix 1).

4.1.2       R&D QA will issue a unique number for every change proposed in the format “CC-XX-YYY” where XX is the year in which the change is proposed noticed and YYY is a sequential number starting from 001, every year. For e.g., The first change proposed in 2009 will be CC-09-001.

4.1.3       R&D QA will maintain a log of all the changes proposed as per Appendix 2.

4.2          Generating a change proposal for review and pre approval

4.2.1       There are six (6) sections to be completed in a change control form (refer to Appendix 1):

·         Change Proposal

·         Items Impacted

·         Any Post Data generation?

·         Pre-Approvals

·         Changes Closeout

·         Post Approval

4.2.2       Originator will contact R&D QA for a change control number and completes the “Change Proposal” details on the form.

4.2.3       Originator will identify whether any items would be impacted by the change and whether there would be any post data generated as a result of the change.

4.2.4       The form is then sent to Head of department/ DI for review and pre-approval.

4.2.5       The Head of the department/ DI reviews the change proposal, may re-assess the items impacted and the post data generation requirements, and/or pre-approves. 

4.2.6       The change proposal is then submitted to R&D Quality for review and pre-approval. 

4.2.7       If necessary, R&D QA will schedule other reviewers/ approvers to assess the change proposal.

4.2.8       R&D QA reviews the change proposal to assess if it could potentially impact the validity or integrity of data, the quality of a product or the safety, welfare or confidentiality of subjects/ patients.

4.3          Approvals

4.3.1       If a change proposal is created in error or determined unnecessary, Head of the Department/ DI or R&D QA will void the change control form and record the details in the change control log along with justification.

4.3.2       If a change proposal is unacceptable as written, R&D QA will request additional work and/ or more information prior to pre-approval.

4.3.3       If a change proposal is acceptable, R&D QA will approve and send the original change control form to the originator for implementation of the change. R&D QA will keep a copy.

4.4          Close Out of Changes Proposed and Post Approval

4.4.1       Originator or ‘Assigned to’ person is responsible to ensure completion of the agreed items and/ or generation of data after the implementation of the change (i.e., Changes Close Out section).

4.4.2        Cross reference to the change control number will be documented in the impacted documents.

4.4.3       If there are no outstanding actions required as a result of the change proposed, then the change control form will be approved and closed after the changes are implemented.

4.4.4       Change control forms will not be closed out with final approval until all required activities stated in the form are completed. Head of department/ DI and R&D QA will review and verify the changes implemented along with any data generated prior to closure of the change control form.

4.4.5       Any activity required as part of a change that cannot be completed prior to close out should be clearly stated on the change control form.

4.4.6       R&D QA will maintain the original change control forms and store as per document retention schedule (GRS026).

5.            Responsibilities

5.1          Originator is responsible for:

·         Proposing changes required and identifying the impact of the change on any items and/ or data

·         Ensuring only the changes proposed are implemented and any actions and/ or post data required is generated and completed

5.2          Head of the Department/ DI is responsible for:

·         Ensuring that staff is trained in all aspects of this SOP.

·         Reviewing and approving changes proposed

·         Re-assigning the impact on change and requirements of post data generation, if necessary

·         Void the changes proposed, as necessary

5.3          Scheduled approver(s) is responsible for:

·         Review and approval of changes proposed as required based on their areas of expertise

5.4          R&D QA is responsible for:

·         Reviewing, approving, and rejecting the changes proposed

·         Inquiring appropriate available expertise from any source in order to assess the change control

·         Scheduling required reviewers/ approvers

·         Review and approve the close out of changes implemented

·         Void changes proposed, as necessary

6.            References

Document Retention Policy (POL-FEM-506)

7.            Appendices

Appendix 1:      Change Control Form (QF005)

Appendix 2:      Change Control Log (QF006)

8.            Revision History

SOP No.	Supersedes No. & Date	Changes made (in brief)
QP002-01	Nil	New Document

END OF THE DOCUMENT

==============================================================

Standard Operating Procedure

Training

(Quality)

QP003

=========Read More======>>>>>