This course provides a basic introduction to the concepts, terms and requirements of Good Manufacturing Practice (GMP) in a health environment.
GMP is defined by WHO as the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
Good manufacturing practice (GMP) is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
cGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality and purity of products by requiring that manufacturers of medications adequately control manufacturing operations.
This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
Operators, technicians, health workers, supervisors, co-coordinators, compounders, store men, dispensers, analysts, chemists, pharmacists, food technologists, microbiologists, cosmetologists and general production, technical, engineering and quality control staff in the pharmaceutical, nutraceutical (baby food), herbal, homoeopathic and cosmetic industries and private as well as government hospitals.
All aforementioned positions include permanent, temporary and casual staff. Vendors servicing industry and hospitals are also eligible.
This is an online course
This course needs to be completed within one month from the date of enrolment.
Topics covered are:
PIC/S PE 009-14 requires regular training of all personnel on the principles of GMP.
Save time to train new and existing employees with a distance course to minimise time out of the workplace
On completion of the course, learners will have knowledge of and understand
Learners must study the Resource Guide and then answer the questionnaire with a pass rate of 50% before certification.
To obtain the certificate of competence, the learner must successfully answer a questionnaire with a pass rate of 50%.