Change Control in Pharma: Requirements and Process 

Change Control in Pharma: Requirements and Process 
PUBLISHED
January 24, 2025
CATEGORY
Regulations & Compliance

Poor change control can pose serious risks for life sciences companies, including legal and financial jeopardy and, most importantly, threats to patient safety. For example, altering drug formulations without adequate testing could lead to dosage errors that put human lives at risk. Such incidents often result in reputation damage that companies then struggle to recover from.  

To prevent this, let’s explore the essentials of change control –– its requirements, process, and best practices. But first, let’s define what change control means in the pharmaceutical industry. 

What Is Change Control in Pharma? 

The change control process involves a set of practices designed to maintain product safety, compliance, and efficacy. This procedure lets companies ensure that all modifications are handled in a structured and efficient manner.

Once reviewed, relevant stakeholders and the quality assurance team approve these changes. Even after implementation, there is still a long road ahead. The company must continuously monitor the change to ensure it does not compromise the product. 

Here are a few examples of changes in the pharma industry that require control:  

examples of change control in pharma

Why Do Pharma Companies Rely on Change Control? 

As mentioned, the change control procedures help maintain product quality and safety. But aside from that, why do pharma companies follow this process? Let’s explore the key reasons: 

  • Compliance: The change control process helps them meet local and international regulations, avoiding costly legal and financial issues.  
  • Efficiency: With proper change control in pharma, companies can reduce downtime and minimize disruptions during any updates or adjustments.  
  • Risk Assessment: It enables thorough planning for changes to address risks early without consuming too many resources. 
  • Transparency: With comprehensive records, pharma companies can easily justify every change when an inspection comes knocking. 

Key Change Types 

The change control process can be both proactive and reactive. Let’s examine them in more detail: 

Proactive 

A proactive change involves planning after a thorough assessment and approval process. These changes can be seen as opportunities for innovation and continuous improvement, whether it is enhancing existing products, technology, or processes. For example, it could be adopting a new manufacturing method or the latest software update.  

A planned change is all about a well-defined strategy. You might need to develop a business case, conduct a feasibility study, create a change management plan, and outline a project plan to bring it to life.  

It is crucial to view any change within the broader context of the company’s goals, values, and mission. Before implementation, key stakeholders should evaluate its impact on the organization as a whole, not just on product quality. 

Reactive 

A reactive change control process is an adjustment prompted by unexpected shifts in the external or internal environment. This often relates to changes in customer needs, market conditions, or regulatory updates. To stay afloat, companies must address factors beyond their control. Evolving expectations, adherence to new standards, and the integration challenges of acquisitions –– all of these require reactive change control for pharma companies. 

Change control management demands a flexible and agile approach. This may involve conducting a gap analysis, developing a change strategy, and evaluating its impact. Effective leadership and strong communication are key to navigating these adjustments and ensuring the process runs as smoothly as possible. 

What Are the Change Control Requirements? 

Change control process requirements vary between companies and regions, but here is a list of the most common ones to give you a general idea: 

EU 1252/2014 

This is a guideline for companies operating in the European Union and dealing with active substances. It requires companies to evaluate how changes in the production process can impact the active substances. 

ICH Q10 

This guideline states that if you are unsure that changes will result in the expected outcomes, there may be a problem that could compromise the product’s integrity. Quality risk management is crucial for evaluating the error likelihood. 

EudraLex Volume 4 GMP 

This is a key requirement for all European drug manufacturers. It establishes written procedures for managing any changes during production. For example, if you decide to upgrade to more innovative equipment, you will need to justify that the change keeps the quality top-notch.  

The requirement also emphasizes the use of quality risk management. This empowers brands to carefully plan these changes and account for all potential impacts on the product. 

FDA 21 CFR Part 211 

This regulation governs the practices of U.S. life sciences companies. Below are the key aspects of its Good Manufacturing Practice (GMP) guidelines:  

  • 21 CFR 211.22: Any proposed change must receive final approval from the quality control unit. This unit must be equipped with all the necessary resources to conduct an effective evaluation.  
  • 21 CFR 211.100: Written procedures for production and process control are mandatory and must be approved by the quality control unit. Employees should fully understand how to manage changes. Any deviations from standard processes require clear justification and thorough documentation.  
  • 21 CFR 211.160: Comprehensive documentation is indispensable, especially in laboratory settings.  

What Is the Process for Change Control? 

Change control process pharma

The change control process flow heavily depends on the nature of the change and the type of your organization. In this section, we will discuss the basic steps you will need to take to manage adjustments to the product, system, or operations.  

Make a change request 

To start, submit a change request by completing the form and documenting the proposed adjustment. Clearly specify whether the change is planned or unplanned and categorize it as minor or major. Be sure to include the specific reasons for requesting the change. 

Review and assess 

Regulatory affairs, quality assurance, and manufacturing must ensure that your proposed change does not compromise product quality or safety and complies with current regulations. To do this, they assess the change’s impact to identify potential issues before implementation.  

Conduct risk assessment 

At this stage, the goal is to spot potential risks associated with the suggested change. It is essential to foresee any external and internal factors that might impact the product and organization. 

Review and approve 

The assigned employees review all data related to the change request, and then either approve or reject the proposal. Some changes may need approval from multiple stakeholders and require cross-functional team cooperation. 

Document the change 

Documentation allows companies to create a transparent workflow, maintain consistency in implementation, and ensure traceability, which is crucial for audits. It covers the details of the change, the rationale behind it, and the decisions made during review and approval. 

Conduct validation activities 

Depending on the nature of the change, you may need to perform validation activities. This presupposes studies and tests to ensure the change does not negatively affect product quality, quality, or safety. 

Notify regulatory bodies 

Some changes may require notifying regulatory authorities, such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). This includes changes significant enough to affect regulatory filings and marketing authorizations for a product. 

Implement the change 

Implement your change according to the documentation created earlier. Organize tasks, assign team members, and establish clear deadlines for effective implementation.  

Sticking to a clear procedure will help you avoid a guess-and-check approach. Ensure that employees have the necessary resources to carry it out without major hiccups.  

Conduct employee training 

Once all approvals are in place, consider providing training if needed. The fear of change can be paralyzing for many employees, so make sure they have enough support to handle the stress. Monitor employees’ progress for greater effectiveness and accountability. 

Track performance 

This step ensures you are on the right track. Identify any deviations from the plan, document them, analyze potential reasons, and develop solutions to get back on course. Keep team members in the loop and encourage prompt assessments to maintain progress. 

Ensure closure 

Once the change is implemented, close the change control process. Make sure all approvals and documentation are complete and up to date. 

Best Practices for Smooth Change Control 

Follow these best practices to ensure a smooth change control processes without hitting rough patches:  

Leave room for dialogue 

Active listening and transparent communication are crucial for effective change control. Ongoing interaction with employees helps reduce their feelings of uncertainty, fear, and resistance while building trust and cooperation. Encourage your staff to share their concerns, contribute suggestions, and ask questions. 

Explain the why behind the change 

People change only when they choose to. Ensure those involved in implementing the change have the necessary context and understand the decision-making process. Explain how the change aligns with organizational goals and impacts their roles. Use a variety of communication methods, such as in-person meetings, emails, and more, to resonate with your team. 

Assign change control ambassadors 

Change control procedure champions are employees who orchestrate staff efforts and drive the change forward. They assign responsibilities, set deadlines, monitor progress, and evaluate effectiveness. Their involvement helps facilitate the process and fosters company-wide alignment in embracing the change. 

Request feedback across all levels 

Let employees’ voices ring. Encourage feedback from team members at all levels to uncover potential blockers and silent resistors. Assign a team member with strong emotional intelligence to collect feedback and share insights with key stakeholders. 

How Does Software Simplify Change Control Management? 

Change is the only constant in life and vital to any company’s growth. However, teams need support to embrace new working methods without feeling overwhelmed or anxious. Software solutions can simplify this transition and enhance team effectiveness. Here are a few possible ways technology can make a difference: 

It allows teams to plan change requests 

Most solutions let users document changes, covering impact assessments, risks, and budgets. Employees can see all tasks, responsibilities, and deadlines. Once a change request is approved, the software automatically notifies employees to remind them of their tasks. This enhances teamwork and fosters greater transparency and accountability. 

It analyzes the impact 

Before committing to a change process, it is essential to understand what’s needed to make it happen. Artificial intelligence (AI)-driven analytics enable stakeholders to visualize the impacts on timelines, budgets, business operations, and resources. This eliminates guesswork and helps make decisions grounded in real-world evidence

It foresees risks 

You should be prepared for worst-case scenarios to safeguard organizational health and product safety. Modern tools help users accurately anticipate these risks and create Plan B, Plan C, and so on. 

It regulates approvals 

Change control software guarantees that only the right stakeholders review and sign off on changes before implementation. Automated notifications keep everyone updated about their responsibilities, while detailed documentation of approvals strengthens accountability and builds transparency. 

Mastering Change Control with Ease 

In pharma, change control is a multi-step, regulated process that calls for strong cross-functional cooperation and dealing with bureaucratic tape. To maximize efforts and automate routine tasks, a robust software solution is essential.  

Viseven, a future-inspired tech company with over 15 years of experience in pharma technology, understands the industry’s unique challenges. We build solutions that address pharma stakeholders’ biggest pain points and needs. The numbers speak for themselves: 80% of our clients come from referrals. 

Need a robust change control solution? Drop us a line, and we’ll get back to you as quickly as possible.