SOP for Change Control

1. OBJECTIVE
To provide a procedure for define the mechanism for the initiate, review and authorization of changes in all master documents, master system and their control

2. SCOPE
It is applicable to handle the change control at the manufacturing facility

3. RESPONSIBILITY
• Executive Quality Assurance
• Asst. manager –Quality assurance & Regulatory affairs
• Technical Director
• Manager Quality assurance

4. SAFETY INSTRUCTIONS
• No “authorized” document can be changes without being duly authorized in accordance with this procedure
• Changes to be established must have sound/ scientific justification.

5. PROCEDURE
5.1 This procedure is applicable to, but is not necessarily limited to all authorized documents/procedure including Validation protocols, Master formula records, Batch manufacturing records, Standard Operating procedure, and Finish product specification, Standard testing procedure, Raw material specification, and Packaging material specification.
5.2 Initial of change (s)
5.2.1 No “authorized” document can be changes without being duly authorized in accordance with this procedure
5.2.2 Each document change request must be initiated by completion of a change control form (CCF) as per Annexure –I.
5.2.3 The Asst. manager of Quality assurance & Regulatory affairs has the responsibility for controlling and tracking the CCF.
5.2.4 The user department shall initiate the changes required by filling and submitted CCF from along with supporting documents to QA department.
5.2.5 Changes to be established must have sound/ scientific justification.
5.2.6 The impact of any proposed change on the quality of the final product must be fully evaluated and documented.
5.2.7 Quality assurance will assign a CCF No. for the documentation.
5.3 Management review and approval
5.3.1 Circulate the CCF together with supporting documentation, to the Head – Quality assurance & Regulatory affairs, R&D, Production, Quality control and Warehouse as appropriate for their review and comments. Cost/ Productivity improvements must be fully justified and counter signed by the Plant Head/ Technical Director.
5.4 Review and authorized process
5.4.1 Submit CCF documents to Quality assurance for review and authorization before implementation.
5.4.2 The Head of Quality assurance & Regulatory affairs must assign a category of change to each CCF.
5.4.3 Category ‘A’ – No regulatory impact.
Category ‘B’ – Minor changes (Notification to the Regulatory authorities required)
Category ‘C’ – Major change/s that (Approval from the Regulatory authorities is required before implementation.)
5.4.4 The review and authorized of a change shall include a sign by Head of Quality assurance & Regulatory affairs, Engineering, Quality control, Production, Warehouse and Engineering.
5.4.5 The Head of Quality assurance & Regulatory affairs must ensure that all information (e.g. dates of submission /approval) relating to notification to Regulatory authorities is promptly transmitted to the Departmental heads to authorized the change (if applicable) shall finally authorize all change control (s).
5.4.6 A duly completed change control form as per Annexure- II shall be finally signed by QA dept.
5.4.7 CCF No will have stamping “CONTROLLED COPY” in red color on right corner on each page of front side.

6. RELATED DOCUMENTS
Change request format – Annex-I
Change Control Issuance Log Book – Annex-II

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
QA Quality Assurance
CCF Change Control Form

9. REVISION HISTORY