What is Change Control :
Any planned permanent or temporary departure or modification or addition or deletion from an approved/qualified process/policy/document/system/material/method/equipment etc. is called as change and the document which is required to capture all the activities is called change control.
CHANGE CONTROL PROCEDURE:
DEFINATION:
Change Control: A formal system by which qualified representative of appropriate disciplines review proposed or actual changes that might affect the validated status of facility, systems, equipments or processes.
Temporary Change: A change (departure from any established procedure/system/process) initiated for the evaluation of proposed procedure/system/process, which has been taken with prior approval to achieve the desired output, allowed for one time change and limited to a particular batch. For example change in batch size, manufacturing equipment, etc.
Permanent change: A change initiated based upon scientific rational or historical GMP data or data generated through temporary changes.
Major Change: Changes, proposed for improvements to process, materials, product and procedures which may have impact upon the identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product. Notification to agency required.
Minor Change: Changes, which does not have impact on the quality attributes like identity, quality, purity, strength, stability, safety, efficacy or physical characteristic of the product.
Changes are divided into two types:
- Permanent Change
- Temporary Change
The change control approval or rejection process shall require to be completed within 30 working days from the date of initiation of the change control.
Change control preferably closed within 90 working days after Head –QA approval.
If change control is not closed within specified timeline, initiator shall raise “Period Extension Request” as per SOP. Initiating department Head shall review the extension request and write justification for delay with impact assessment. QA shall assess the impact of delay in action completion and approve / reject the Period extension request. Period extension shall be allowed for two times only. After this new change control shall be initiated.
Change control trending shall be carried out Quarterly basis
CLASSIFICATION OF TYPICAL CHANGES
| Type of change | Critical | Major | Minor |
| Change in systems | Ö | ||
| Change in manufacturing formula/process / New Products | Ö | Ö | |
| Change in expiry (related to stability) | Ö | Ö | |
| Change in critical Raw Material/solvent | Ö | Ö | |
| Change in specifications and test method | Ö | Ö | |
| Change in SOP for addition / deletion | Ö | Ö | |
| Change in equipment | Ö | ||
| Modification in critical equipment | Ö | ||
| Modification / Up gradation in facility | Ö | ||
| Change in stability program | Ö | Ö | |
| Change in key raw material source or supplier | Ö | ||
| Change in storage conditions | Ö | ||
| Change in primary packing material | Ö | ||
| Change in secondary packing material | Ö | ||
| Change in packing style | Ö | ||
| Change in printed text on label | Ö | ||
| Change in manufacturing location/site | Ö | Ö | |
| Change in manufacturing Batch Size | Ö | Ö | |
| Change in packing batch size | Ö | ||
| Change in control systems i.e. computers, Data Collection | Ö | ||
| Formats and internal labels | Ö | ||
| Deletion of a product | Ö |
Note: The list can be elaborated based on practical changes occurring at the locations.
Product Change : Change in key RM/Solvent, BOM, Process Parameters, In-process control, pack style, packing material, introduction of New Product etc
Engineering Change : Change in Facility design, equipment type, Maintenance parameters, utilities.
System Change : Change in software/firmware or its configuration etc.
Documentation Change: Change in SOP, STP, Document control procedures etc.
| Type of Change | Recommendations |
| Change in systems | Training, Change in relevant documents, and/or validation wherever required. |
| Change in manufacturing formula/process / New Products | Validation of three consecutive batches, with stability studies, method validation, specification, STP, Cleaning Validation verification in facility. Information and pre-approval from customer/regulatory authorities (as applicable) |
| Change in specifications | Stability studies on the changed specifications. Updating of SAP. Registration Dossier updation. |
| Change in test methods | Analytical Method validation, Updating of TDS, Registration Dossier updation. |
| Change in SOP for addition / deletion of instructions/formats/labels | Training, Change in relevant documents. |
| Change in expiry | Stability studies, Change in relevant documents, intimation to concerned departments. Registration Dossier updation. |
| Change/modification in equipment/New equipment | Equipment qualification. SOP preparation, Training, Equipment list updation |
| Changes made for Marketing Authorization | Process related / system related. |
| Modification/Up gradation in facility | Facility qualifications, SMF update |
| Change in stability program | Stability studies in change conditions. |
| Change in critical raw material source | Vendor approval as per SOP |
| Change in storage conditions | Stability studies in changed conditions, Change in relevant documents/labels |
| Change in primary packaging material | Stability study, Change in relevant documents/BPR, Specification updation. |
| Change in pack style | Change in relevant documents/BPR, intimation to concerned departments. |
| Change in printed text | Change in relevant documents/BPR. Intimation to concerned departments. |
| Change in manufacturing batch size, manufacturing site/location | Partial validation of three consecutive batches, accelerated/long term stability studies depending on the change. |
| Change in control systems i.e. computers, configuration of software/firmware, etc. | Validation of the new control system. |
Note: This list is not exhaustive and can be extended based on practical changes occurring at the locations.
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