The European Medicine Agency (EMA) has strict regulations covering every aspect of your production process. In biotech manufacturing, good practice compliance laws, (GxP compliance) ensure that products meet the highest quality standards and all the safety requirements
These regulations cover not only the facilities for manufacturing but also the personnel as well. Not following GxP compliance regulations now can lead to future problems with the government.
In this article, we will discuss the importance of GxP compliance in biotech manufacturing and the key aspects of achieving and maintaining compliance.
What is GxP compliance and Why is important in the Biotech Industry
GxP refers to “good practice,” with the “x” representing a variable that can apply to various industries, including biotech. It refers to a set of quality guidelines and regulations that must be followed to ensure the safety and efficacy of products in various industries.
The biotech industry has made the manufacture of biotech products possible. These products have a significant impact on the health and well-being of patients, so it only makes sense that the industry is looking more closely at their quality and safety.
GxP compliance is crucial in the biotech industry because it helps to ensure that products are manufactured in a consistent and controlled manner and that they meet the highest standards of quality.
GxP compliance also helps to guarantee that companies are operating within the boundaries of the law. Compliance failure can result in serious legal consequences. What’s more, non-compliance, and all these legal consequences can damage a brand’s reputation which therefore has a significant impact on its future growth and success.
Key Aspects of Achieving and Maintaining GxP Compliance
Maintaining GxP compliance means that the manufacturing processes are “validated”. Validation can be accomplished by demonstrating that a system or process is operating as intended and meets the requirements of GxP regulations. Validation is essential because it helps to ensure that products are manufactured in a consistent and controlled manner.
In order to ensure GxP compliance, it is imperative to prioritise both personnel qualification and training. All individuals involved in the manufacturing process – including operators, supervisors, and managers – should receive proper training. Additionally, personnel qualification should be conducted to assess whether employees possess the necessary skillset, and experience to fulfil their job duties.
Ensuring Systems and Processes Meet Regulations
Meeting all the requirements for equipment can require a system to be in place to keep track of all of the different regulations. The specific system needed to remain GxP compliant varies depending on the manufacturing process and specific regulations that apply. Some examples are change control systems, document management systems, deviation management systems, and quality management systems among others.
In order for your system to be effective and meet legal standards, you will need to “validate” said system.
Validation is a three-stage process that includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Installation qualification (IQ): verifies that equipment and systems are installed correctly.
- Operational Qualification (OQ): verifies that equipment and systems operate correctly.
- Performance Qualification (PQ): verifies that equipment and systems perform correctly under normal operating conditions.
Biotech companies must follow this rigorous testing and documentation process to ensure that all systems and processes meet the necessary standards and regulations. This three-step process often updates to respond to the changing needs of the industry due in part to changing politics and the shifting needs of customers.
Training and Personnel Qualification: Ensuring Competence and Skills
Continuous education among biotech personnel is necessary to remain GxP compliant to respond to the changing needs of the industry.
Technical competence is one of the easiest ways to prove that your personnel are able to properly do the work they are assigned and this can only be achieved through certification training. These qualifications are reviewed by relevant government agencies that also deal with the regulations you abide by.
GxP compliance in the biotech industry requires that personnel have the appropriate qualifications for their job functions and that their qualifications are periodically reviewed and updated as necessary.
Training programs must be comprehensive, including both theoretical and practical components. They must be reviewed and updated from time to time to ensure that personnel are aware of any changes in regulations or best practices.
Consequences of Non-Compliance with GxP Regulations
Non-compliance with GxP regulations can lead to a range of negative impacts for life science companies, including financial penalties, product recalls, loss of reputation, and legal consequences such as civil or criminal charges.
Financial penalties are one of the most common consequences of non-compliance. Regulators can impose significant fines on companies that fail to comply with GxP regulations, which can be a substantial financial burden for many companies.
In addition to financial penalties, non-compliance can lead to the loss of business opportunities as potential customers may choose to work with companies that have a better compliance record.
The loss of reputation can be a significant consequence. Companies that are found to be non-compliant may lose the trust and confidence of their customers and stakeholders, which can be difficult to recover.
Negative publicity can harm a company’s reputation and lead to a loss of market share. Finally, non-compliance with GxP regulations can also result in criminal charges in some cases.
In conclusion, GxP compliance is essential for ensuring the safety, efficacy, and quality of products in the biotech industry. Seabrook Global is in the business of helping you do just that – to remain compliant and ease the production process.
Seabrook Global is a leading provider of engineering, automation, and compliance services to the life sciences industry. We understand the importance of GxP compliance in the biotech industry and offer a range of solutions to help companies meet regulatory requirements.
Our team of experts can assist with GxP cloud compliance, document control, personnel training and qualification, and other critical aspects of GxP compliance.
We offer GxP validation services to ensure that software, equipment, and processes meet regulatory requirements. We also provide guidance and support for compliance with industry-specific regulations. Our services are designed to help companies achieve compliance and maintain compliance over the long term.
Get in touch with one of our experts today at Seabrook Global. Call our Ireland office at +353 21 4800 840 or our office in Indiana USA at +1 317 426 0699 for guidance.