| Good Manufacturing Practices or GMP covers a wide | | | | is so that we can understand the risk posed to |
| range of processes, products and production | | | | humans and third parties including the environment.o |
| techniques involved in the manufacture and | | | | Good Manufacturing Practice (GMP) Inspectorate - |
| distribution of medicinal supplies. The pharmaceutical | | | | GMP is concerned with the manufacture and control |
| industry is heavily governed by GMP and the | | | | of medicines and devices to ensure that the quality |
| regulatory bodies entrusted with upholding Good | | | | standards appropriate for the intended use of the |
| Manufacturing Practices. | | | | product is kept to. Quality control and production |
| In the United Kingdom the Medicines and Healthcare | | | | methods are both inspected by this MHRA |
| products Regulatory Agency (MHRA) is the | | | | department.o Good Pharmacovigilance Practice (GPP) |
| government body responsible for ensuring that | | | | Inspectorate - Medicine manufacturers are required |
| medicines and medical devices are safe for patients | | | | by law to monitor any side effects their products |
| and that every possible risk is reduced with the | | | | have and the risk they might pose to patients. |
| subsequent problems prevented. | | | | Pharmacovigilance takes evidence from healthcare |
| There are five inspectorate bodies within the MHRA | | | | providers and patients and then assesses this |
| which visit pharmaceutical companies to assess | | | | information to see if there are any new hazards to |
| whether their practices and finished products comply | | | | be found in medicinal products with the aim of |
| with GMP standards. These five inspectorates are;o | | | | reducing the risk to patients. |
| Good Clinical Practice (GCP) Inspectorate - which | | | | Pharmaceutical companies must have a thorough |
| assesses the compliance of companies to the | | | | understanding of GMP regulations in order to ensure |
| internationally recognised ethical and scientific quality | | | | that their practices do not breach the guidelines. To |
| requirements which must be observed for designing, | | | | gain this knowledge, companies will often make use |
| conducting, recording and reporting clinical trials that | | | | of GMP consulting offered by independent agencies, |
| involve the participation of human subjects.o Good | | | | so that every aspect of their work is in line with GMP |
| Distribution Practice (GDP) Inspectorate - Every | | | | regulations. |
| product has a product specification and this outlines | | | | GMP consultants are experienced scientists, |
| how the medicine or device should be stored, | | | | pharmacists, researchers and other professionals who |
| transported and handled in order to maintain its | | | | have worked in the industry before becoming a |
| quality, this Inspectorate ensures this.o Good | | | | consultant. GMP consulting can save companies the |
| Laboratory Practice (GLP) Inspectorate - GLP is a | | | | embarrassment, cost, reputation and brand damage |
| framework for scientists to work within when | | | | as well as the loss of profits that come when a |
| planning, performing, monitoring, recording, reporting | | | | business fails to comply with GMP. Therefore, it is a |
| and archiving laboratory studies and their results. This | | | | worthwhile and cost effective expenditure. |