Q&A with Rhona McAteer, our GMP Expert
Looking for expert advice on Good Manufacturing Practice (GMP)? Look no further!
With over 25 years in the pharmaceutical industry – initially in steriles QC microbiology before moving into pharmaceutical and medical device QA – Rhona McAteer, our Associate Director and GMP expert, has you covered.
Rhona provides unique specialisms in audit, training, and advice on a broad range of GMP/ GCP / ISO topics and is our Subject Matter Expert on GMP / GDP and Medical Devices. She ensures the distribution of regulatory information to colleagues, ensures best practice in audits, and acts as specialist client relationship manager providing professional advice on GMP and Medical Device matters.
Here, she explains the concept of GMP, and why it’s so important.
What is GMP, and why is it so important?
What – A set of regulations, codes, and guidelines for the manufacture of drugs, medical devices, diagnostic products, and Active Pharmaceutical Ingredients (APIs). GMP is that part of the Quality Assurance System which ensures that products are manufactured consistently to a quality fit for their intended use.
Why – Patient Safety, we are or will be patients at one time or another in our lives, that makes it vital we can be assured of the safety, quality, and efficacy of our products. In our industry product testing of medicines on its own cannot ensure quality. This is because a lot of testing is destructive. GMP tries to ensure that quality is built into the organisation and the processes. In our industry mistakes can be fatal.
GMP guidelines and regulations address different issues that can influence the safety and quality of a product. How can a company ensure they’re complying with GMP guidelines?
Through constant vigilance, in GMP we are always moving forward, whether that is through advances in technologies or by increasing our knowledge through experience. We need to continually challenge our systems making sure they are fit for purpose and in line with best practices while always keeping patient safety in the forefront of our thoughts. The balance of risk, compliance and safety is always challenging and the need to ensure our systems are practical and consistently achievable is key.
What are the most common compliance challenges, and what are the most effective ways in which management can clearly communicate the importance of GMP?
Challenges
Over complicated systems and processes – inefficient is not always non-compliant however, complicated systems and processes inevitably lead to inconsistencies and compliance issues.
Under resourcing and lack of appropriate QA oversight.
Lack of appropriate root cause investigations, over reliance on human factors / error as root cause without comprehensive review of all aspects of systems leading to in appropriate CAPA.
The best way management can communicate the importance of GMP is through example, we need to believe and extol the benefits of our systems, while resourcing them appropriately and supporting our staff.
How can Tower Mains support you?
We offer flexible and cost-effective Quality Assurance services when and where you need them – from short ad hoc projects to long-term QA collaborations across the regulatory and non-regulatory fields.
To find out more about our range of QA services, including GMP, click here, or email us at info@towermains.com.