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E-Learning Course: Essential Good Manufacturing Practice (GMP) for Laboratory Analysts (Certified)
CompuPharma Ltd
This course covers everything an entry-level analyst needs to know about CGMP (current Good Manufacturing Practice) in an analytical laboratory.
It introduces the pharmaceutical industry and its products. It looks at the historical basis for CGMP and how industry legislation has evolved up to the present day.
The focus then shifts to the laboratory - a typical routine of a laboratory analyst is presented, including responsibilities and duties. The different categories of tests - chemical, physical and microbiological – are described in detail. The importance of labelling and recording is emphasized. The concept and operation of a Laboratory Information Management System (LIMS) is also described.
The course continues with GMP rules of the laboratory. The proper procedure for receipt and storage of samples is described. Use of Standard Operating Procedures (SOPs) and correct completion of records is dealt with in-depth. Solution preparation and equipment preparation are also described along with testing procedures and recording and sign-off of results.
Finally, there is an in-depth treatment of out of specification (OOS) and atypical results, which includes possible causes, the investigation process and preventive measures.
This course consists of a series of lessons:
1) Introduction to the Pharmaceutical Industry (PGB-800)
2) Testing Categories (PGL-304)
3) Laboratory Information Management System (PGL-306)
4) Laboratory GMP (PGL-510)
5) Out of Specification and Atypical Results (PGL-500)
Lessons can also be purchased individually. Please see the “Also available” links below for further information on each of the individual lessons.
Also available
E-Learning Module: Introduction to the Pharmaceutical Industry
E-Learning Module: Testing Categories
E-Learning Module: Laboratory Information Management System
E-Learning Module: Laboratory Good Manufacturing Practice (GMP)
E-Learning Module: Out of Specification and Atypical Results
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