Change Control SOP

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Change Control SOP

This Change Control Standard Operating Procedure (SOP) for a well structured Change Control Process is ready to use and meets GMP authorities’ expectations. The 10-page SOP includes a 2 pages template and only needs some minor modification before it can be followed by your personnel and guarantees an effective Change Control system.


SOP Change Control General

Without a robust and effective change control system you will not be able to adjust systems and processes assuring compliance and staying competitive within the industry. Managing changes probably guarantees your company’s future success.


Scope of Change Control SOP:

The purpose of this SOP is to describe in detail the change control process. The Process starts with a request for a change followed by the mandatory assessments and approvals. This standard process ensures that all planned changes related to all aspect of manufacture, testing and distribution are reviewed, assessed and approved by technical and quality competent personnel. One of the main tasks is to evaluate all potential impacts followed by correlative consequences of the requested change on product quality, current Good Manufacturing Practice (cGMP), including qualification and validation and the regulatory file/dossier before approval and implementation of a change control request.


Change Control Objective:

This procedure applies to all new and existing manufacturing/packaging processes, utilities, major equipment, computerized systems, facilities, drug products and drug substances, raw materials, components, testing requirements, specifications and systems for marketed products and clinical trials (clinical, pre-clinical and stability with GMP implications). Documents and systems that may be impacted by a given change in any of these areas include, but are not limited to, all master documents, Marketing Authorization Applications (MAA’s), New Drug Applications (NDA’s), validation, stability protocols and control systems


Regulatory basis, reference documents for Change Control System: 

CFR 314.70 “Supplements and other changes to an approved application”
Commission Regulation EC 541/95 “Variation to the terms of a marketing authorization”
ISO 9004 “08.8 Design Change Control”
ISO 9004 “11.6 Process Change Control”
PIC – PH 1/96
ICH Q7A chapter 13 “Change Control”


SOP Change Control Table of Content:

1     Purpose

2     Objective

3     Regulatory basis, reference documents

4     Responsibility and accountability

4.1       Applicant/Change requester

4.2       Area Experts / Accountable Area Leaders

4.3       Quality Assurance

5     Related documents

6     Definitions

6.1       Like for like replacements / changes

6.2       Temporary and Permanent Changes

7     Procedure

7.1       Raising a Change Control (Form Section 1)

7.2       Assessment of the proposed change (Form Section 2)

7.3       Change implementation / Action Plan (Form Section 3)

7.4       Change Pre Approvals (Form Section 4)

Responsibility of the applicant / change requester

Responsibility of Quality Assurance

7.5       Change Post Approvals (Form Section 5)

Responsibility of the applicant / change requester

Responsibility of Quality Assurance

8     Attachments

Change Control Form

9     SOP distribution

10         Health, safety and environmental considerations


Size and Format of SOP:

  • Microsoft Office 2003
  • Word File
  • 10 pages procedure includes attachement
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