The main motto behind the General Manufacturing Practices training (GMP training) is to ensure that the quality of dietary supplements, medicines and medical devices is maintained consistently and that each and every batch produced is factual scientifically.
As of today, all of the three product sectors are under regulation either of the FDA or of any other government body. And this makes it a tedious task for manufacturers to ensure quality control.
This is where GMP training steps in. it helps manufacturers and their employees understand the regulations as also their impact on the processes and finished goods. Also, this will help the manufacturers to not only asses their own processes but also make them understand where their suppliers maybe lacking and this in turn will help them source raw material that is compliant with the GMP laws thus bringing about a 360 degree change.
There are basically NINE main areas which are included in GMP training:
I. Standard Operating Procedures or SOP’s: how to evaluate your manufacturing processes and operation with SOP’s.
II. Raw Material Testing: Testing and audit of the raw materials and the suppliers.
III. Validation: Extensive testing of all the equipments, formulae and procedures so that they measure up to the product standardizations already established.
IV. Cleaning: A cleaning procedure that has been validated by experts is supposed to be conducted after manufacturing of each batch and is inspected by the quality control team.
V. Equipment Maintenance: all the equipment that is used has to be tested and certified on a frequent basis to ensure optimum work output and quality.
VI. Environmental Controls: It is stated in the GMP regulations that all the equipment, raw materials, packaging materials and the finished goods should be stored in facilities that are environmentally controlled.
VII. Product Testing: the ‘use-by date’ of the products should be found out by conducting sufficient tests on the products to ensure that they are safe.
VIII. Labeling & Packaging Requirements: A set GMP format has to be followed for the packaging and labeling of all products.
IX. Documentation and Traceability: Each and every batch of finished goods has to b documented. The same goes for all the processes involved. Also, each batch has to be traceable through documentation as this will help in case there is any issue with the same.
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