Follow
Change Control is a set of coordinated activities through which the desired change is implemented in an existing function, process, or product.
Changes should be reported through change control system in Production, Quality control, Quality assurance, Stores, Engineering and R&D departments.
two types of change –unplanned and planned changes.
#Unplanned Changes
An unplanned change is unexpected and requires immediate action.
For example, if a product is recalled from the market due to any problem, it is considered an unplanned change.
#Planned Changes
A planned change is executed with proper planning and a fixed timeline. Its execution is planned before its occurrence with proper resource allocation, approvals, and documentation.
For example, suppose a machine is to be replaced with another machine. In that case, the replacement process is planned before the execution, such as arranging an area to start work, shifting the machine and installation activities.
Following are the changes which are to be reported by change management process:
1. Production:
• Change in Location.
• Change in Equipment.
• Change in Batch size.
2. Engineering:
• Change in any equipment.
• Critical Part of any equipment.
• Facility, Design layout.
3. Research & Development:
• Change in Specifications of Raw Material/Packaging Material/Finished product.
• Addition / Deletion of any Raw material in the product.
• Change in quantity of Raw material in the product.
• Addition/Deletion of any manufacturing Steps.
• Change in Shelf Life.
• Change in Specifications of In-process / Intermediate materials.
• Change in Storage conditions.
• Change in method of analysis or change in sampling plans and method.
• Change in Hardware / Software of any Computerized Analytical Instruments.
• Change in Stability Protocols.
4. Materials (Raw & Packaging Material):
• Change in source of any Raw Material or primary packaging material.
5. Quality Control:
• Change in method of analysis or change in sampling plans.
• Change in Hardware / Software of any Computerized Analytical Instruments.
• Change in Stability Protocols.
• Change in specifications of Raw Material / Packaging Material / Finished product.
• Change in Specifications of In Process / Intermediate Materials.
6. Quality Assurance:
• Change in Sampling Plan/Quantity of Samples.
• Change in Validation Protocols…etc
7. Information Technology:
• Change in Hardware / Software.
8. Cleaning Procedure:
• Change in cleaning agents or cleaning procedures
Changes in the pharmaceutical industry can be categorized into:
..Minor
..Major
..Critical
A change control process can be summarized in the following steps:
-Identification
-Justification
-Review and Approval
-Communication
-Training
-Implementation
-Evaluation
References
Annex 15 of EU GMP
ICH Q10
