Good Manufacturing Practice (GMP) is a requirement for all pharmaceutical and medical device manufacturers within the UK. Working under GMP comes with a number of requirements that impact the day to day duties of engineering and scientific staff within these organisations such as tracking changes, ensuring regulatory compliance and preparing for external audits. The need for all process, equipment and systems changes to be fully documented, validated and the need to ensure compliance at every stage of manufacturing requires a particular way of working that would not be required for less regulated sectors.
As GMP requires manufacturing to take place in a clean, environmentally controlled and hygienic facility with validated procedures and documented processes there are a number of additional steps when making engineering changes. This creates specialist roles required to manage these changes.
GMP impacts engineering teams at all levels and creates additional stages when implementing changes to manufacturing systems, computer systems or installing new equipment on site. All staff need to be trained to work to best practice and compliance. All changes must be documented and validated to GMP to ensure that quality and conditions are maintained. GMP guidelines do not state how products are manufactured but set out a number of general principals that should be followed when manufacturing. When a manufacturing process is being set up there can be a number of ways to ensure compliance with GMP and it is the responsibility of the manufacturers on site quality teams to set processes in place for this.
These practices are implemented with the aim of protecting consumer and patient health by ensuring quality is maintained within the medicine, medical device, API or food product being manufactured. In some industries, complying with GMP is required by regulated bodies such as the Federal Drug Authority (FDA) or Medicines and Healthcare products Regulatory Agency (MHRA). Regulated bodies are required to conduct inspections of manufacturing facilities to ensure that GMP is being followed; these can be scheduled or unannounced.
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