GOOD MANUFACTURING PRACTICE WHAT IS GMP GMP guidelines

GOOD MANUFACTURING PRACTICE

WHAT IS GMP? GMP guidelines are a form of regulation. All industries that follow GMP guidelines follow a few basic guidelines: Quality assurance Good manufacturing practices for pharmaceutical products Sanitation and hygiene Qualification and validation Complaints Product recalls Contract production and analysis Self-inspection and quality audits Specific industries will have more specific guidelines.

• The first instance of GMP guidelines being introduced and enforced was in 1941. 300 people were killed when they took sulfathiazole tablets laced with phenobarbital. Since then new regulations and guidelines have been added. • A case where the GMP guidelines were ignored was in the 60’s. Thalidomide was used as a pill for morning sickness and as a sleeping pill. However a side effect of it was that mothers who took the drug gave birth to babies with deformities. This is an example where the drugs effects were not fully validated. The consequence of this was that GMP guidelines became much stricter and drugs would have to undergo a even longer period of testing. • GMP guidelines are followed so that the FDA can check if individual batches of goods are manufactured according to the manufacturing criteria.

WHAT CAN GO WRONG IF THE REGULATION ARE NOT FOLLOWED If GMP guidelines are not followed, there are many things that can go wrong. Chemicals could be mixed up leading to chemists giving patients the wrong drug. Doctors could prescribe too much or too little of a medicine. Medicine could become contaminated if GMP guidelines are not followed in the manufacturing process. This could lead to an unwanted reaction in the person taking the medicine or death.

HOW IT IS ENFORCED GMP inspections are carried out by National Regulatory Agencies inside the European Union Inside the UK, GMP inspections are carried out by Medicines and Healthcare Products Regulatory Agency (MHRA) Most agencies are authorised to conduct inspections unannounced

SIMILAR PRACTICE SYSTEMS Good agricultural practice (GAP) Good laboratory practice (GLP) Good clinical practice (GCP) Good regulatory practice (GRP) Good distribution practice (GDP) Good transportation practice (GTP) Good pharmacovigilance practice (GVP)

REFERENCES Good manufacturing practice (2016) in Wikipedia. Available at: https: //en. wikipedia. org/wiki/Good_manufacturing_practice#Other_good_practices apps. who. int/prequal/trainingresources/pq_pres/Tallinn. . . /GMP_inspections_en. ppt http: //gmpnews. ru/wp-content/uploads/2010/05/History-gmp. pdf