Change control is a systematic approach that ensures changes are implemented in a controlled and coordinated manner to a product or system
- It includes all changes that could affect the product quality like sop change in SOP, BMR, facility, labeling, market, vendor, testing procedure, specification
- Change control minimizes the risk that changes can have on the quality or process characteristics
- Each change requires a review and authorization to keep the system in its original state of “proven suitability”
The Importance of Change Control in the Pharma
Change control is a crucial aspect of the pharmaceutical industry, as it ensures that any changes made in processes, equipment, or documentation are properly documented and regulated.
Change control refers to the process of making changes in the pharmaceutical industry. These changes can include modifications in equipment, processes, facilities, or documentation.
The purpose of change control is to ensure that any changes made are justified and properly documented. In the pharmaceutical industry, change control is essential because it helps maintain the quality and safety of products. Any changes made without proper documentation can lead to issues in the manufacturing process and compromise the quality of the final product. One of the main reasons for implementing change control is revalidation.
The Importance of Change Control in Ensuring Product Quality and Compliance
Revalidation is the process of validating a process or equipment after making changes to ensure that it still meets the required standards. This is important because changes in processes or equipment can affect the quality and safety of the products being manufactured.
Another reason for change control is to address problems or issues that arise in the manufacturing process. By documenting and analyzing these problems, companies can identify the root cause and take corrective actions to prevent them from recurring.
Change control also plays a crucial role in maintaining the stability and reliability of products. Stability testing is conducted to ensure that products remain stable throughout their shelf life. If any changes are made to the manufacturing process or formulation, it is important to re-evaluate the stability of the product to ensure its effectiveness and safety. In addition to these reasons, change control is also necessary to comply with regulatory requirements.
7 Steps for Change Control Management in pharma
Following are the steps for Change Control Management in pharmaceutical industry
1. Reporting Change control
- Short Description
- Present Status
- Proposed Status
- Change Justification
- Type of Change (Technical Change, Product Change, Temporary Change)
2. Department head approval
3. Risk impact analysis
- Risk Assessment
- Impact on Packaging Material
- Impact on the Product Quality
- Other Sites Impacted
- Attachment (Impact analysis cum preliminary risk analysis)
4. Exert evaluation
5. Economic evaluation
- Registration Fees
- Other Fees/Costs
6. Regulatory Data
7. Change Closure
- Change Implementation Date
- Change Summary
Change Control Procedure in Pharmaceuticals
Types of Changes
There are two types of changes: temporary changes and permanent changes. Temporary changes are changes that have a specified limited duration or are implemented for a specified number of batches. These changes can be approved prior to implementation. On the other hand, permanent changes are changes that are consistently followed by the system. These changes require a scientific justification, impact assessment, and risk analysis.
Initiating a Change
When initiating a change, the change initiator must fill out a Change Control form. This form should include details about the existing change, proposed change, and the reason for the change. The scientific justification for the change should be clearly defined, and an impact assessment and risk analysis should be conducted. If necessary, supporting data should be attached to justify the change.
Review and Approval
Once the Change Control form is filled out by the initiator, it is reviewed by the user department head. If the review is satisfactory, the form is then submitted to the Quality Assurance (QA) department. The QA department thoroughly reviews the form and supporting documents for correctness and completeness. They also review the risk assessment provided for the change. If the review is acceptable, the form proceeds to the next stage.
Impact Assessment and Categorization
The Change Control coordinator from the QA department selects reviewer departments for impact assessment and comments. Based on the details provided, the coordinator reviews the form and categorizes the change as major or minor. Major changes are those that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, and potency of the product. Minor changes have minimal potential to have an adverse effect on these factors.
Circulation and Forwarding
After the impact assessment and categorization, the initiator circulates the Change Control form to the concerned departments for their review and comments. The form is also forwarded to the regulator and APIs department for impact assessment or resubmission filing, if required. Major changes require a separate Major Changes form, while minor changes can be included in the regular Change Control form.
Rejection and Completion
If a Change Control form is rejected, the initiator is informed, and the rejection is recorded in the Change Control log. The completion of all activities stated in the action plan is necessary for the closure of the Change Control form. Once all activities are completed, the dually filled Change Control form, along with all attachments, is sent to QA for review and closure. QA reviews the form for completeness and correctness and ensures that all necessary actions have been completed.
Retention and Timeline
All Change Control forms should be closed within 90 days from the final approval or as per the target completion dates mentioned in the form. These forms should be retained in the custody of the Quality Assurance department. It is important to note that the change control management system timeline does not apply to change controls related to the introduction of new products.
Conclusion
The change control procedure in the pharmaceutical industry is a critical process that ensures any changes made to systems, materials, documents, methods, equipment, or products are properly documented, reviewed, and approved. It involves initiating a change, conducting an impact assessment, categorizing the change, circulating and forwarding the Change Control form, reviewing and closing the form, and retaining the form for future reference. By following this procedure, pharmaceutical companies can ensure that any changes made are in compliance with regulations and do not compromise the safety or effectiveness of their products.