Q&A: Good manufacturing practice and what it means for our clients
What is good manufacturing practice (GMP)?
The principal aim of good manufacturing practice (GMP) is to safeguard the public.GMP is the implementation of principles and guidelines which ensure that medicinal products and devices are consistently produced and controlled to suit their intended use.
There are legal requirements for manufacturers of medicinal products and devices to be in compliance with GMP. These requirements are enforced in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) and in the USA by the Food and Drug Administration (FDA).
What does GMP demonstrate?
Compliance with GMP demonstrates that we have employed a fully documented and monitored quality assurance system. This ensures the accuracy, integrity, legibility and availability of our test data.What quality control methods does Smithers implement in our facilities?
Our GMP compliant services adhere to a strict Quality Assurance system which is implemented through standard operating procedures and a system of routine inspections to ensure that our facilities are maintained in good condition, our testing equipment is routinely checked and calibrated, our testing procedures are repeatable and reproducible and that our employees are well-trained and knowledgeable in their field.What testing services do Smithers offer under the GMP umbrella?
Our services compliant with GMP include:
- Design verification testing
- Stability studies
- Batch release
- Post market surveillance.
Why is this so important for the medical and pharmaceutical industries?
Patient safety is a critical concern for all medical and pharmaceutical manufacturers, which is why the quality of the supply chain – which includes testing services – is so important. Using a supplier who is compliant with GMP gives manufacturers reassurance about the quality of the service provided.Find out more about our medical device testing.