Hi, Everyone. In this post i have been shared change control procedure in pharmaceutical industries.
change control is one of the major activity in pharmaceutical industry. in this post you can get complete information, ideas and better understanding about the change control procedure.
Overview:
Change control is an formal procedure to initiate, review and approve the changes in pharmaceutical industry. which is applicable for change in Equipment's, Change in Route of synthesis, Process raw materials, critical process parameters, batch size increase or decrease, specification and testing procedure, batch manufacturing record, cleaning records etc.
Types of change control:
Change controls are classified in to two classes which are,
1) Temporary change control: Temporary change is nothing bu temporary changes. that is we know before it occur.
For Example: Change in like to like additional equipment. if you are manufacturing "X" product.
you need some additional equipment for process if equipment are engaged for other products.
at that time you can take additional like to like equipment ( Means Reactor to reactor, glass lined to glass lined, centrifuge to centrifuge etc).
by initiating the temporary change control you can take the additional equipment's.
2) Permanent change control: Those changes which are permanent in nature.
For Example: Change in batch size form 100 Kg to 200 Kg permanently.
- All the user department shall be responsible to initiate the change control regarding any changes required in their department.
- Quality assurance department shall issue, review and approve the changes.user department will raise an indent to QA for change control. QA will issue the change control form by allotting the change control number.
- Change control numbering system shall be allotted as CC/XX/YY/ZZ where, CC- Change control XX- Department code YY- Serial number starts from 001 for the calendar year ZZ- Last two digits of the calendar year. For Example: CC/QA/002/23.
- After getting the change from the QA, user department will fill the change control form along with proposed changes. filled change control form will be circulated to respective departments like Quality control, Quality assurance, Production, Maintenance, EHS, HR for there review comments.
- Respective departments will review the proposed changes and make there comments. if any impact on there side they will write what as applicable, if there is no impact they will write not applicable.
- after review, change control will be transferred to QA department. QA Head/Designee will review the proposal and proceed for approval. if the proposal is suitable then QA head will approve otherwise proposal will be rejected. in case rejection communication will be provided to user.
- QA head or his designee will decide whether the change control is Minor or major.
- The changes which are not having significant impact on the quality and yield of the product called as minor change controls.
- The changes which are significant impact on the quality and yield of the product called as Major change control.
- all the major changes shall be intimated to relevant customers. major changes include, change in site, change in process, change in batch size, change in new equipment, change in specification etc. intimation to be provided to customer by QA department. after getting the approval from the customer QA will approved the proposed change control and will implement the action plans.
- Initiating department will establish all the respective action plans and QA will follow up the action plans for closure of the change control.
- All the change controls shall be closed within 90 days. if any change control not closed within the stated timeline then extension form shall be filled.