Follow
Objective: Change control is a formal system by which qualified representatives from appropriate disciplines including quality organization, review proposed changes that might affect validated status, regulatory compliance or in-house specifications. The representatives will define & approve appropriate action(s) to be taken, so that the facilities & operations retain their validated state of control. The objective of this procedure is to control, review, approve and implementation of all changes which have potential to impact the quality of the drug products during their life cycle and to formally document before authorising for implementation. The change control procedure will ensure:
– Safeguard of quality (Safety and efficacy of the product)
– Traceability of changes made through the lifecycle of a product or facility
– Assessment and management of risks associated with the implementation of changes.
Scope: This procedure is applicable to all planned changes that have the potential to affect GMP, Product Quality, Safety, Efficacy, Stability, Validation status of Processes, Facilities and other quality systems of (Company Name).
Responsibility
Head of Quality.
Precautions
No Change Proposal/trial works will be implemented until it is formally agreed by Head of Quality.
Procedure
6.1 The change control procedure shall be followed if any of the following changes are required.
6.1.1 Production – Change in Location, equipment, Process, Process control
parameters or batch size.
6.1.2 Engineering – Change in any equipment, critical part of any equipment or Process control parameters in utilities.
6.1.3 R&D – Change in Raw Materials/Packaging Materials in Finished product, their specifications, process &/or control parameters.
6.1.4 Experimental Changes – Experimental changes planned to generate data prior to any permanent change. This activity shall be, governed by the R&D department.
6.1.5 Materials – Change in source of any raw material or primary packaging materials.
6.1.6 Marketing/Sales – Change in customer/market requirement, artwork – text matter/dimension of packaging material, mode of packing, product price.
6.1.7 Quality Assurance
6.1 7.1 Change in sampling plans/equipment or procedure.
6.1.7.2 Change in specifications and Standard Test Procedures.
6.1.7.3 Change in stability study protocol.
6.1.7.4 Regulatory changes triggered by GMP, Reference Standards updates.
6.2 For any document changes/revision a Document Change/Approval Request Form (FQA/004) shall be raised.
6.3 The change control proposal can be classified by following way.
6.3.1 Minor Change: The change is unlikely to have a detectable impact on identity, purity, strength, safety or quality of the product or process.
6.3.2 Major Change: The change is likely to or will have a significant impact on identity, purity, strength, safety or quality of the product or process.
6.4 The change control mechanism shall be processed as per Annexure – I.
6.5 Originating department shall raise a request for issuance of Change Control Form (CCF) to Quality Assurance department.
6.6 Quality Assurance department shall issue the copy of Change Control Form (Annexure –II) to originating /initiating department.
6.7 QA shall assign a serial number (Annexure – III) to change control form as follows:
XX/YY/ZZZ
Where ‘XX’ represents for the department code (Refer to SOP No.: QA-003)
‘YY’ represents the last two digits of the year (10 for 2010)
‘ZZZ’ represents for serial number of the change control, which starts from 001 for the calendar year. Separate files shall be followed for OSD, MDI Unit, DPI Unit & MDI Unit – II.
6.8 Change control proposal shall be raised / initiated by a person of the relevant department and checked by department head.
6.9 If any change is required due to Regulatory Authority, R&D and Regulatory Affairs Manager shall initiate change control.
6.10 For any change, the change control coordinator will arrange a meeting of relevant stakeholders/ Technical Experts (Change Control Panel) for Impact Analysis/Risk Assessment. The critical assessment of in-depth risk factors will be carried out in any change. Actions to be identified against the critical assessment of all the immediate and future risks. For Impact Analysis, Annexure – VI will be used and the Risk Assessment will be done as per SOP (QA074). For Impact Analysis QA shall issue the Impact Analysis form number and maintain the log register (Annexure – VII) and for Risk Assessment QA shall issue the Risk Assessment document number and maintain the
log register as per SOP (QA074).
e.g. IA/001
Where,
IA is the Impact Analysis
/ is separator
001 is the sequential number.
6.11 The initiator shall forward duly filled change control form to QA department with details including impact analysis report where necessary.
6.12 The Change Control form shall be sent to Production Manager or Quality Control Manager or Engineering Manager or Purchase Manager or any other business partner (as applicable) for his/their agreement on the proposed change.
6.13 Then the Change Control Form shall be forwarded to Regulatory Affairs Manager.
6.14 Regulatory Affairs Manager evaluates the change requested and compares it with the approved regulatory findings and the guidelines of that country. In case there is a requirement that the change is required to be, approved by Regulatory Authority, the Regulatory Affairs Manager shall forward the necessary details to the respective Regulatory Authority.
6.15 Regulatory Affairs Manager may decide to give clearance for taking trial/validation batches pending approval from Regulatory Authority. However, changes shall only be implemented after receiving approval from Regulatory Authority.
6.16 Once the approval is received, Regulatory Affairs Manager shall attach a copy of the approval to the change control form and forward it to R&D to Validation Manager with his comments.
6.17 If the change control does not require prior approval from Regulatory Authority, the Regulatory Affairs Manager shall forward the change control form to R&D department with his comments.
6.18 R&D Manager shall take necessary action, on the basis of comments of Regulatory Affairs Manager and shall forward the change control form to Quality Assurance department with his comments.
6.19 In case no Validation is required, then Validation Manager shall send the change control form to Quality Assurance Manager with his remarks.
6.20 In case Validation is required, then Validation Manager shall indicate following actions in change control form.
6.20.1 Validation required and detailed remarks.
6.20.2 Validation Manager shall co-ordinate for preparation and approval of protocol and subsequent validation activity.
6.21 Quality Assurance Manager shall review the change control form and place it to Head of Quality for approval.
6.22 Head of Quality shall approve the change control form for implementation.
6.23 QA Manager shall send a copy of the approved change control form to the originating department for implemenattion.
6.24 The Originating Department on receiving the approved change control form shall arrange for its implementation.
6.25 Concerned personnel shall be trained for carryingout the specific activities those are necessary for the change and document the details.
6.26 Head of Quality shall finally review and close the change control form with remarks and signature.
6.27 Change control should be closed within 30 days of initiation. Close time can be more than 30 days depending upon the nature of the change. In that case purpose of such delays shall be recored.
6.28 QA shall ensure the availability of check list for change control (Annexure – IV) for the reference.
6.29 QA shall send one copy of Change Control Form to originating department and retain the original for record.
6.30 All related documents shall be updated eventually by concerned department.
6.31 All controlled copies of the changed documents like Master Formula Records (MFRs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), Specifications and Test procedures (STPs), General Test Procedures (GTPs) and stability study protocols and reports etc. shall be sent to regulatory affairs department if necessary.
6.32 QA Manager shall monitor the status of change control through the Change Control Tracker in PC (Annexure – V) and place the status monthly Quality Council Meeting for review.
6.33 QA with the assistance of originating department shall compile all relevant information/ documents to make the change control document a stand alone document.
6.34 QA shall prepare the trend charts for change control preferably on yearly basis.
