Our talent specialist, Erin Curley, explains the quality standards of the pharma industry and their importance to the consumer.
Good Manufacturing Practice, also known as GMP, is a set of regulatory standards that manufacturers are required to meet in their production processes. These are in place to ensure consistency, high quality and safety for the consumer. GMP covers all aspects of production from raw materials to manufacturing through to packaging and labeling. It ensures the prevention of cross-contamination, mislabeling of the products and inconsistent product quality. GMP guidelines vary from country to country, but overall ensure that manufacturers implement an effective process.
These regulations are so important, as the quality of the drug is not visibly apparent to the consumer; it’s an assumption all of us have made when purchasing medicine at least some point in our lives. The duty of the company to ensure quality assurance and quality control at each stage of the process is essential. Due to pharmaceutical products being critical to our wellbeing, the industry is highly regulated and has strict procedures to follow to prevent any negative side effects. As a consumer, this is something we have to have trust in and the regulations enable this.
Other pharma regs – what’s the difference?
GMP and ISO standards are often compared to each other. To clarify, GMP are regulations and legal requirements that pharmaceutical manufacturers must adhere to, where the focus is to ensure the product is manufactured to a high-quality standard. Whereas ISO certifications are in place to help pharmaceutical companies manage their operations whilst staying compliant. ISO 9001 is the most widely-used quality management standard internationally, with its focus on all departments and processes of an organisation.
In addition to these, there is the Current Good Manufacturing Process, also known as cGMP. This safeguards correct design, monitoring and control of manufacturing processes and facilities for pure, high-quality drug products. For Contract Development and Manufacturing Organisations (CDMOs) to follow cGMP, they are required to source high-quality raw materials and apply rigorous quality management with the correct protocols in place. Following these formal practices, CDMOs reduce and avoid completely any errors of contamination or mishaps taking place. The reason for cGMP being implemented is to ensure consistent and reliable manufacturing of high-quality drug products. This will involve equipment being regularly inspected, any adjustments needed identified and implemented, and data being correctly stored, which leads to the prevention of corruption.
GMP and cGMP are very similar, as they both focus on reducing cross-contamination or the mislabeling of drug products. However, the main difference is that cGMP focuses on continuous improvement, resulting in the most up-to-date standards or technologies being implemented, which leads to the highest quality. As a result of this, generally cGMP is more expensive than GMP thanks to its rigorous results.
An essential standard
Overall, GMP plays a crucial role in ensuring the safety and quality of the pharmaceutical products that we, the public, have access to. If these regulations were not in place, this could lead to life-threatening effects on the public’s health. It is also important for regulatory compliance and risk management, which are critical for the success and reputation of companies operating in regulated industries.
Contact us today
To discover more on this topic, talk about your talent requirements, or discuss your career ambitions in this field, contact Erin today on +44 (0) 239 232 2367.