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 labeling 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.
Topics Covered:
- Introduction to the Pharmaceutical Industry - Routine of a Laboratory Analyst - Testing Categories - Laboratory Information Management Systems - Laboratory GMP - Out of Specification & Atypical Results
Certificate
There is a 16 question assessment associated with each lesson within the Course and we offer a Certificate Service in which Users who achieve 100% in the assessment associated with each Lesson of a Course are deemed to have passed the Course, and are posted a Certificate.
