Change is a continuous process. When millions of lives depend on it, it has to be assessed and evaluated with intensive care. Pharmaceutical companies are highly regulated, and even if they were to implement the slightest change in their SOPs, machines, or any other aspect, it has to go through an arduous process. Change control in pharma carries out this function. It is the formal procedure that evaluates, approves, and implements any such modification. Let’s understand more about change control in the pharmaceutical industry and its processes.
What is Change Control in Pharma?
Change control in pharma is a standardized process that allows and approves any modification. From initiation to approval, it is used to understand, assess, and execute any planned changes in pharmaceutical products, equipment, and compliance. The change control definition in pharma refers to a formal, systematic process with various stages that ensures that the planned change doesn’t hinder product quality or good manufacturing practice (GMP) requirements.
This multi-stage assessment captures the reason for the change, the foreseeable impact, and checks off all the requirements, documenting everything down to the last minute detail. Once the proposed change gets the nod, change control for pharmaceutical industry ensures that the system is restored to a validated state post-modification without disturbing patient safety.
Why Is Change Control Important in the Pharmaceutical Industry
Pharma caters to the people of our country, and it needs astute supervision. Medicines protect us, but what protects the medicines we use? Change control in pharma helps ensure consistent product quality and avoids any unauthorized changes to the product. It helps companies meet regulatory compliance and prevent any unforeseeable risks while administering any change.
Change control in pharmaceutical industry also documents every action and ensures that the changes are assessed and engineered to maintain a validated state. Pharmaceutical engineering services can support these changes through process optimization, equipment assessment, facility design, commissioning, and validation.
Types of Change Control in Pharma
Changes are omnipresent, and they come in different proportions, too. Here are the types of change control in Pharma:
Minor Change
A change that doesn’t require a major overhaul in the SOPs or affect the product quality greatly. For example, a minor administrative or documentation update will fall under this category.
Major Change
Explain changes that could affect processes, systems, equipment, or existing approved conditions. Replacing critical manufacturing equipment is one such example.
Critical Change
Changes made to the product quality, safety, or regulatory compliance are classified under critical change and require far more attention than usual.
There are broader classifications in the change control types. Temporary and permanent changes are two of those. A temporary change is implemented for a stipulated time period. Once the desired goal is achieved, the company often reverts to its original operations.
A permanent change replaces the previously placed operation under approved conditions permanently. Changes involving regulated electronic systems may also affect existing GxP applications and should be appropriately evaluated.
Change Control Procedure in Pharma
The change control procedure in pharma is standardized and simple. It is an organized system to manage modifications in a pharma company. Here is how it works:
Step 1 – Initiate the Change
The process kicks off by documenting the current condition, proposed change, reasons, and justification for it.
Step 2 – Perform Impact Assessment
This step measures the impact of the proposed change and how it affects the product, process, equipment, system, or validation requirements.
Step 3 – Evaluate the Risk
Risk evaluation analyzes the potential consequences the proposed change could bring if it gets implemented. Quality risk management helps in identifying and controlling the potential harm associated with the change.
Step 4 – Review and Approve
The relevant departments review the proposed change, while the Quality Assurance (QA) team estimates it for quality and compliance requirements.
Step 5 – Plan the Implementation
The first step towards implementation begins with planning. The plan of action covers details such as the activities required, responsibilities, testing validations, documentation updates, and training requirements that are needed for this change. Pharma project management may be called for modifications involving facilities, systems, or specialized equipment to ensure smooth coordination between the teams involved.
Step 6 – Implement and Verify
Following various quality assessments, the change is implemented only after getting all necessary approvals. For computerized systems, existing software and configuration changes are part of the validation requirements, with computer system validation services brought in where necessary.
Step 7 – Review and Close
After implementation, the change is reviewed thoroughly to verify if the intended outcome was achieved and all required records are documented. Most importantly, there must be no issues that surface later, and once all of this is achieved, the change control is formally closed.
Change Control Process Flow
The change control process flow begins with a change request and moves through impact assessment and risk evaluation. It later pivots towards a review that approves the implementation, and lastly it gets verified before officially closing it. Each and every stage is documented to maintain a clear record, and the implementation takes place only after getting every single approval.
ICH Guidelines for Change Control
ICH guidelines for change control are a framework that manages changes without compromising quality and compliance. The 2 guidelines here are ICH Q10 and ICH Q9.
ICH Q10
This framework explains how changes are managed within the Pharmaceutical Quality System (PQS). It states that all proposed changes must go through the process of evaluation and review, must be approved before implementation, and should be evaluated once after implementation.
ICH Q9
It focuses on quality risk management. A proposal is evaluated based on the intensity of risk. It helps organizations identify risk and provide an appropriate level of assessment and control based on risk. For computerized-system changes, GAMP 5 also supports a structured, risk-based validation approach.
Without these change control guidelines in pharma, managing change would have been an uphill battle.
Deviation and Change Control in Pharma
Deviation and change control in pharma deal with two different situations. Here are the core differences:
| Change Control | Deviation |
|---|---|
| Deals with a planned change | Deals with a departure or unexpected event |
| Assessed well before the change is made | Investigated after an event occurs |
| Requires review and approval beforehand | Requires investigation and assessment to understand what happened |
| Used to manage an intentional modification | Used to address departure from an approved condition |
A deviation investigation may identify the need for a permanent modification to something that was proposed to change. Such a modification will eventually be managed through the formal change control process.
What Should a Change Control Format Include?
A change control format records all important details to track the proposed change. It includes:
- Basic details: Change control number, date
- Current and proposed state: Existing condition, proposed change, reason/justification
- Assessment: Impact assessment, risk assessment, classification
- Scope and actions: Departments affected, actions required
- Approval and implementation: Approval details, implementation details
- Verification and closure: Verification, closure.
Companies must follow their approved SOP for change control when initiating a change. When a procedure changes, the people handling that department will require appropriate pharmaceutical training courses before implementation.
Examples of Change Control in Pharma
Example: GxP Software Upgrade
Upgrading software used in a regulated process is an example of change control in pharma. The change is initially proposed, and the impact is assessed; from there, the validation requirements are reviewed in order to gain approval. Following the implementation, it gets tested, documented, and once the outcome is verified, the change is closed.
Final Word
An effective change control in the pharma process helps pharma companies manage changes without losing product quality and maintains compliance. A properly governed approach ensures that the changes are assessed, documented, tested, and verified. If you need support systems or validation compliance,
Contact our pharmaceutical validation experts at QIS.
Frequently Asked Questions About Change Control in Pharma
1. What is change control in pharma?
Change control in pharma is a documented process that oversees any changes that are required at a pharmaceutical company.
2. What are the types of change control in pharma?
Major, minor, and critical changes are the 3 types of change control in pharma. Temporary change and permanent change are also part of change control, depending on the organization’s system.
3. What is the change control procedure?
The change control procedure involves Initiation, assessment, risk evaluation, review, approval, implementation, verification, and then closure once it’s done.
4. What is a change control process flow?
A change control process flow shows the stages through which a proposed change moves from initiation till final closure.
5. What is the difference between deviation and change control in pharma?
Deviation and change control in pharma are two different things. Change control is planned before implementation, whereas deviation addresses any unexpected departure from an approved condition.
6. What are the ICH guidelines for change control?
ICH guidelines for change control include ICH Q10 for change management and ICH Q9 for risk-based evaluation, forming key change control guidelines in pharma.
