Description

Pharmaceutical companies recognise that an efficient change control system is the only way to ensure they can rapidly adjust systems and processes so as to stay competitive and continually improve effectiveness and quality. Managing changes will have a major impact on any company’s future success. 

This Standard Operating Procedure (SOP) will help you simplify change control and documentation by putting in place a powerful and extremely effective change control system. It does this by acknowledging: 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, 11.6 Process Change Control, PIC – PH 1/96 and ICH Q7A chapter 13 ‘Change Control’. 

This Standard Operating Procedure (SOP) describes the change control process flow in detail, starting with a change request then following the necessary assessments and approvals. This standard process ensures that all planned changes affecting any aspect of manufacturing, testing and distribution are reviewed, assessed and approved by technical and quality-competent site personnel, including the quality assurance department. 

The main task in Change Control is to evaluate potential impacts and any related consequences in terms of product quality, safety and Good Manufacturing Practice (GMP). The qualification and validation statuses as well as the official registration must be checked before a change can be implemented. 

This 8-page SOP, which includes a Change Control Form, is ready to use and only needs a small amount of site-specific modification before it can be adopted for your operations.

Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Applicant/Change requester
4.2 Area Experts / Accountable Area Leaders
4.3 Quality Assurance
5. Procedure
5.1 Raising a Change Control (Form Section 1)
5.2 Assessment of the proposed change (Form Section 2)
5.3 Change implementation / Action Plan (Form Section 3)
5.4 Change Pre Approvals (Form Section 4)
5.4.1 Responsibility of the applicant / change requester
5.4.2 Responsibility of Quality Assurance
5.5 Change Post Approvals (Form Section 5)
5.5.1 Responsibility of the applicant / change requester
5.5.2 Responsibility of Quality Assurance
6. Definitions
6.1 Like for like replacements / changes
6.2 Temporary and Permanent Changes
7. Distribution
8. Attachments (Change Control Form)