Change control for pharmaceutical companies: What you need to know.

It's not just important, it's mandatory: the strictly regulated pharmaceutical industry relies on strict change control. This is known as change control management. If changes occur in pharmaceutical companies, it manages and controls them. But why are adjustments so strictly regulated in this industry? Careful control in a regulated environment ensures that medicines are produced and brought to market safely, effectively, with high quality and always with exactly the same content. Change control has an impact on many areas of the company, including

• Production processes, e.g. changes to manufacturing processes
• Formulations, e.g. adjusting the ingredients or composition of medicines
• Packaging, e.g. new design or content quantity of medicine packs
• Regulatory requirements, e.g. requirements changed by authorities regarding the manufacture, approval and marketing of the product

At the same time as change control, companies in the pharmaceutical industry are focusing on risk management and quality control. It should be said in advance that although the three areas are separate criteria, they are closely interrelated.

This is what essentially distinguishes them:

Change control

Change control is concerned with managing and controlling all aspects of change. From the development to the marketing of a drug, all processes are included.

Risk management

Risk management, on the other hand, is responsible for identifying, evaluating, monitoring and controlling the safety, efficacy and quality of medicines in order to ultimately be able to influence the risks. The aim is to develop strategies to minimize risks and, in the best case, to completely prevent unwanted incidents.

Quality control

The third criterion, quality control, uses tests and techniques to ensure that the high quality standards for medicinal products are met.

In order to reliably meet the strict requirements of the pharmaceutical industry, the three areas are interlinked. Together, they form the basis for ensuring that patients are supplied with safe, effective medicines.

All this theory begs the question: what changes are typical for companies in the pharmaceutical industry? Adaptations vary from project to project, but the following four are particularly common:

1. Manufacturing processes are changed.

If the manufacturing process is changed, this affects the way in which drugs are produced. In addition, the required equipment, technologies and production processes may be affected.

2. The formulation is changed.

The adjustment of ingredients in particular means that the formulation of a medicine has to be adapted. Sensitivity is required here, as such changes can affect the efficacy, safety or stability of the product.

3. Packaging and labeling are changed.

In the pharmaceutical industry, it is not only the inner values that count - the labeling also plays a major role. If the packaging or labeling of a medicine is changed, this can have an impact on its identification and use. Confusion and incorrect use must be prevented.

4. Regulatory requirements change.

If regulatory requirements and specifications regarding the approval, manufacture and marketing of medicines change, pharmaceutical companies must efficiently ensure that the new conditions are fully met.

The entire pharmaceutical industry is subject to numerous legal and regulatory frameworks that also influence change control. Compliance with these is crucial for pharmaceutical companies. This is the only way to guarantee the safety, efficacy and quality of medicinal products and ensure regulatory compliance. There are a large number of such framework conditions that pharmaceutical companies must fulfill. Some important examples are

Drug approval regulations

Drug manufacturing regulations and procedures vary from country to country. If a change to the manufacturing process is implemented, it must be fully documented.

Good Manufacturing Practice (GMP)

GMP regulations stipulate which standards must be adhered to in the manufacture of medicinal products. If there is a change in the manufacturing process, this must be documented, evaluated and approved in accordance with the GMP guidelines. One part of the GMP guidelines is the ICH10 document, which relates to pharmaceutical quality systems.

Standards

Quality management standards, probably the best known of which is ISO 9001, define strict requirements for the quality management system of pharmaceutical companies. This also includes the processes for change control.

Food and Drug Administration (FDA)

Regulatory authorities such as the FDA specify guidelines and requirements relating to the modification of approved drugs. The European counterpart to the FDA is the European Medicines Agency (EMA).

Good Documentation Practice (GDP)

The Good Documentation Practice (GDP) guidelines define standards according to which pharmaceutical processes and changes must be documented. GDP ensures that such adjustments are properly documented and can be traced at any time.

Complying with regulatory requirements, complex production processes and the need to fully document changes pose major challenges for companies in the pharmaceutical industry. They are complex and sensitive, and the slightest mistake can have fatal consequences. But with the right strategies and solutions, even the trickiest of tasks can be mastered with ease.

In order to fulfill change control management correctly and reliably, the pharmaceutical industry often relies on the following methods:

Change control procedures

Change control procedures define the criteria that must be adhered to when evaluating, approving, implementing and monitoring the respective changes.

Process validation and qualification

Particularly critical changes, for example to the manufacturing process or formulation, require process validation measures. These ensure that changes are implemented properly and that the quality of the end product is always consistent and reproducible.

Exchange and training

Good communication is essential to ensure that everyone involved - both externally and internally - is informed about changes and their documentation. Employees can attend training courses to prepare for upcoming changes and acquire the necessary knowledge about the new processes.

Thorough documentation

Another measure that supports change control is careful documentation. Thanks to this, individual steps can be traced back if necessary and are traceable at all times. Such documentation management usually includes the storage and recording of:

• Change requests
• risk assessments
• validation reports
• Training documents

Continuous improvement (CT management)

Change management control is not a closed measure, but should be understood as a continuous process. Companies benefit from regularly reviewing and scrutinizing affected processes in order to continuously improve and develop resilient best practices.

However, in addition to methods and strategies, tools also support companies in handling change management. They automate processes, increase efficiency and ensure that changes are traceable.

Change management software

Software that is specially produced for the digital processing of changes efficiently supports pharmaceutical companies in change control. It handles the recording, tracking and management of change requests, often via workflows, notifications and document management.

Document management systems

A document management system also facilitates change control. It reliably manages and controls change documentation, logs and guidelines in a central location. Documents can be accessed digitally at any time and without complications.

Risk management software

There are also dedicated software solutions for risk management, which can support change management processes. They usually include tools for risk analysis, assessments and change tracking.

Project management tools

Platforms that facilitate collaboration and tools for efficient project management help companies to implement their changes in a meaningful and targeted manner. They simplify communication and enable everyone involved to work with the same database - important prerequisites for facilitating change control processes.

ERP systems

ERP systems are a solution that can facilitate the entire process in companies. Workflow functions, integrated process management, lot tracking and industry-specific tools for recipe management, quality control, etc. provide pharmaceutical companies with security and efficiency for change control. The necessary basis for this is provided by the industry-specific ERP Yaveon 365, especially for the pharmaceutical industry, with the specific Quality Control App and many other necessary functions.

For pharmaceutical companies, efficient change control is an essential part of their day-to-day work. But meeting the requirements can be challenging. Appropriate mechanisms and digital tools help to document changes not only completely, but also accurately and smoothly. If you want to kill two birds with one stone, opt for an ERP system. This is because the software not only facilitates the change control process, but also automates many other processes that are time-consuming and error-prone when operated manually.

Do you also want security for your change control?

Get to know our industry-specific ERP Yaveon 365 better and start reliable change processes.