The change control process is a set of coordinated activities through which the desired change is implemented in an existing function, process, or product in the pharmaceutical industry.
Change control aims to involve all the relevant departments for successful change implementation by following the regulatory requirements.
For example, if the Production Department decides to change the packaging type of a finished product, it will execute this by a change control process.
In this article, we will look at the definition of a change control process, its types, and the steps of implementing a successful change control process. Finally, we will cover the types of change and how software can help implement a successful change control process.
Jump to sections:
- What Is Change Control in Pharmaceutical Industry?
- What Are the Different Types of Change?
- What Are the Different Change Classification Categories?
- Change Control Regulatory Requirements
- Change Control Process Flow
- Best Practices for Change Control
- Software for Streamlining Change Control Management
- Frequently Asked Questions About Change Controls
What Is Change Control in Pharmaceutical Industry?
Change control in the pharmaceutical industry is used to modify any process or pharmaceutical SOP.
It ensures that the change does not affect the output’s intent and fulfills all the quality principles associated with that specific product or process.
Definition of Change Control by Annex 15 of EU GMP
EU GMP is a European body that specifies principles and regulations for ensuring standardization in medicines and pharmaceutical products in European Union. The EU GMP is divided into various annexes, each annex describing different pharmaceutical industry processes.
Annex 15 describes the principles of Qualification and Validation for facilities, equipment, utilities, and processes, including Change Control.
According to Annex 15 of EU GMP, change control is defined as:
“A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action to ensure and document that the system is maintained in a validated state”
Let’s go through some of the examples.
If a Production Department decides to upgrade existing equipment due to capacity issues, the upgradation activity will take place by appropriate change control procedures.
If the R&D Department decides to change the glass container for a specific pharma product from Type I to Type II, it will initiate the change using a change control process.
Another example could be changing room dimensions to accommodate the newly installed machine. The Engineering Department will use the change control procedure to change the room’s physical dimensions.
With an eQMS software solution like SimplerQMS, you can streamline your change control management process by automatically collecting data and sending the changes through the document approval process. Furthermore, you can easily link various objects such as design control change records, nonconformance, risks, customer complaints, CAPAs, audit findings, and other documents.
What Are the Different Types of Change?
Your organization will typically face two types of change –unplanned and planned 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.
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 acquiring an area to start work, shifting the machine, and installation activities.
What Are the Different Change Classification Categories?
Changes in the pharmaceutical industry can be categorized into:
They are categorized according to their impact on the resulting product, process, or system.
Let’s look briefly at these types with an example of each.
A minor change impacts a part of the process without affecting the characteristics of the final product.
The final product contains all the quality principles that were present before the implementation of a change.
For example, if a Production Department upgrades a mixing machine to a higher-speed machine, this change does not significantly impact the final product’s characteristics. The only impact could be on production time, while all other parameters remain the same.
A major change affects the Current Good Manufacturing Practice (cGMP) characteristics of a product, facility, process, system, or equipment.
These changes can influence the process’s reliability and can be overcome through proper measures or testing procedures.
For example, if the Quality Department decides to change the sterilization temperature from 100⁰C to 121⁰C for a particular product, it is categorized as a major change.
A critical change can seriously impact the product quality causing the product to fail in delivering its required characteristics to the end-user.
This change is irreversible, and further testing or improvement is impossible.
For example, it is critical if a change in product formulation causes an undesirable alteration in product color. The affected product cannot be used for human consumption, and it must be recalled from the market.
Change Control Regulatory Requirements
Change control is a regulatory requirement by various regulatory bodies, and the change control process gets reviewed during the inspections.
Some regulatory bodies that require a change control process include the following.
EU GMP – Chapter 5.25
EU GMP is a European authority that controls the manufacturing and distribution of medicinal products by establishing principles and guidelines. Chapter 5 of EU GMP includes guidelines for the production, and section 5.25 includes guidelines for the change control process.
It highlights the importance of verifying and cross-checking the impact of change on the output product. The output product must demonstrate its approved quality specifications.
The process must also be reproducible after the implementation of change.
ICH Q10 Pharmaceutical Quality System Guidelines
The ICH Q10 quality system guidelines are for implementing Quality Management systems in the Pharmaceutical industry.
In it, the Change Control is defined in section 3.2.3, called “change management system”. According to ICH 10, the change control process is utilized as a means of continual improvement in products and processes.
Quality risk management is utilized to evaluate changes that must be carried out regarding marketing authorization and product/process understanding. The evaluation team must consist of personnel from all relevant departments such as Pharmaceutical Development, Manufacturing, Quality, and Regulatory Affairs.
Eudralex Volume 4 Annex 15
Annex 15 of Eudralex are the guidelines for Product Qualification and Validation for facilities, equipment, utilities, and processes, including the procedures for Change Control processes.
According to these guidelines, procedures must be written before initiating a change control process. Quality risk management should evaluate the impact of change on product quality, pharmaceutical quality systems, documentation, validation, regulatory status, calibration, maintenance, and any other system.
Authorized personnel must approve the change according to the principles of the pharmaceutical quality management system.
Finally, the effectiveness of change must be confirmed for the successful implementation of change.
CFR 21 Part 211
CFR 21 part 211 are the United States’ current good manufacturing practices for finished pharmaceutical products.
For the change control process, the following sections are relevant.
CFR 21 Part 211.100
CFR 21 Part 211.100 describes the importance of written procedures for production and process control, including the changes. These procedures must be written by authorized personnel with Quality Control’s final approval. Deviation from written procedures should be avoided, and in case it occurs, it must be recorded and justified.
CFR 21 Part 211.160
CFR 21 Part 211.160 describes the importance of written procedures for various processes, including changes in a laboratory environment.
CFR 21 Part 211.22
CFR 21 Part 211.22 authorizes the Quality Control Unit to approve or disapprove the change. The organization is responsible for providing all resources, facilities, and expertise to Quality Control.
Change Control Process Flow
For effective change control, the procedure must be implemented through a series of steps.
The change control process should be described in the organization’s quality manual. The quality manual should also include Standard Operating Procedures – SOP for implementing the change control process.
A change control process can be summarized in the following steps:
- Review and Approval
This is the first phase which describes and explains the need for a change.
For example, what causes the change to initiate?
A change request form is used to initiate the process that contains all the relevant fields for recording information.
Then, the change is justified by proper reasoning.
For example, what causes the initiator to initiate the change.
After initiating and justifying the change, the Departmental Head will review the change request form.
The head will ensure that the change is justified correctly and will not decline quality, product, or process performance. The head will also check to see whether the required documentation is appropriately completed or not.
If the head does not approve the change, the process will stop.
If approved, the head will forward it to the Quality Department for further action.
Additionally, the QA Department will categorize the change according to its category – minor, major or critical.
Review and Approval
The Quality Department personnel will review the change request form and attached documents.
If there are any shortcomings, they will be sent back for correction.
When the Quality head is satisfied with all requirements, the final approval will be given.
Thereafter, the QA Department will communicate the status of the change control process to the initiating department.
Before the initiator department starts implementing the change, the Quality Department will train the department to implement the change smoothly.
The Quality Department will highlight the required activities with deadlines for effective implementation.
Using an eQMS software to document employee training is a proven method for showcasing training effectiveness after a change. Plus, the system allows you to easily present audit-ready training evidence during regulatory audits.
The department will implement the change control process per Quality Department directives.
After the change is implemented, the department will inform the Quality Department to review and approve the implemented change.
Lastly, the initiator department will be evaluated to track the change control process’s progress and ensure satisfactory implementation.
Best Practices for Change Control
Let’s look at some best practices that can streamline an effective change control process in the pharmaceutical industry.
Changes Should Be Adequately Justified
There must be proper reasoning for the change, indicating the shortcomings of the present process.
It must also include the benefits that the proposed change will have on the existing process and the final product.
Finally, the departmental head must approve and acknowledge the proposed change. The approval from the head will help in resource allocation and execution of activities.
Change Must Be Approved From the Quality Department
The Quality Department guarantees the implementation of quality principles in the pharmaceutical industry.
The change process should not be executed unless approval from the Quality Department, as it will assess whether there are any quality breaches in the proposed changes.
Change Should Be Analyzed Using a Risk-Based Approach
The proposed changes should be analyzed on a risk-based approach for continual improvement.
It helps analyze the aftermath of change on a proactive rather than on a reactive basis when a problem occurs.
Change Must Be Categorized
Different nature of change requires a different approach for its implementation and resource allocation.
For this purpose, the change must be categorized into minor, major, or critical.
Major changes require regulatory filings, without waiting for regulatory body inspection to occur.
At the same time, minor changes are usually recorded in the logbook, which will be a helpful resource for the organization’s improvement.
Software for Streamlining Change Control Management
Conventionally, the change control process is executed manually through paper-based systems, which creates a lot of papers that must be appropriately recorded and stored.
Too many papers increase the risk of human error and take a lot of time to manage.
This can result in disconnected sections, un-signed papers, and record duplication.
A better alternative is a software QMS system like SimplerQMS with a built-in change control management module. It integrates with all quality processes, allows you to easily link documents, and stores everything in a single centralized system.
Changes executed using SimplerQMS are easily traceable via time-stamped audit trails. Moreover, the system provides secure FDA 21 CFR Part 11 compliant electronic signatures and reporting features allowing for full traceability of your documentation.
Document routing, tracking, notifications, and approval all happen automatically, taking control of all integral activities from humans to minimize human error and ensure compliance.
By fully utilizing such a system you can assure that work instructions and engineering changes can be implemented without anything falling through the cracks.
Frequently Asked Questions About Change Controls
Change control procedure is a process to implement change in an ongoing process. The change procedure is initiated by the concerned department and occurs as a result of guidelines, recommendations, audits, or an external complaint.
The main difference between change control and deviation is that change is an updated stage that conforms to the regulations and quality principles. While deviation is also an updated stage that does not conform to the regulations and quality principles.
Recommended Reading: Guide to Deviation Management Process
Change control in the pharmaceutical industry is initiated using a change request form. The initiator department’s personnel will provide all the relevant information in their relevant fields. Such as originator and originating department, existing process, proposed activity/change, Risk Assessment, and reason of change.
The change control process is a critical activity in the pharmaceutical industry to correct any existing function, process, or product.
The success of the change control process can be increased by various factors such as training, improved documentation, and above all, using an eQMS software like SimplerQMS.
eQMS software takes control of all critical steps such as documentation and activity planning. It allows the organization to focus more on solving problems rather than planning the change control activity. To learn more about the SimplerQMS QMS software solution and its change control management capabilities we recommend booking a personalized demo and talking to our system specialists.