Glp Gmp Certification
Cfpie also offers the widest range of pharmaceutical and medical device certification programs designed to enhance career advancement.
Glp gmp certification. Good laboratory practices glp and good manufacturing practices gmp. Good laboratory practice glp this course provides training on good laboratory practice for non clinical laboratory studies that reflects regulations and best practices established by key regulatory agencies and guidelines. Gmps are the minimum practices processes and standards required for manufacturing. The fdas regulations on current good manufacturing practices cgmp affect many different phases of pharmaceutical.
Presently over 3500 individuals are enrolled in certification programs covering glp gmp clinical compliance process validation global regulatory affairs document management qsr and cmc. These courses take place at the customers production facility. This white paper outlines the differences between glp and gmp regulations that are significant to testing and provides guidance on when these regulations are applicable. Good laboratory practices glp facility certification program in august 2016 the fda publishedand is currently reviewinga revised set of proposed good laboratory practices glp regulations.
The eca academy offers several standard gmp in house training courses which can be enhanced or customised to suit every companys needs. They are currently conducting surveillance inspections of laboratories testing sites and cros to ensure that facilities comply with glp and can maintain data integrity for their studies. Gmp and glp certifications gmp certification. In addition to public gmp training courses and conferences the eca academy also organises gmp in house training courses.
Glp and gmp regulations pertaining to testing serve two different purposes. It is 7th largest country by area and second populous country and the biggest democracy in the world. India is a vast country of south asia. Regulatory agencies of the life sciences.
The glps are designed to protect scientific data integrity and to provide the epa or fda with a clear and auditable record of open ended research studies. The current good manufacturing practices certified professional or cgmp. The current good laboratory practices certified compliance professional cglp.