GMP Manufacturing Principles and Their Significance

Good Manufacturing Practice or GMP manufacturingcarry out procedures properly but also to document
principles are the cornerstones of quality systemstheir activities. Fifth, records made during actual
utilized in the manufacture and quality testing ofmanufacturing processes must show that all required
products for which a high level of quality is anprocedures are followed; that quantity and quality of
overriding concern. Examples of such products areproducts are at expected or required levels; and that
pharmaceutical products such as drugs and theirany deviations are both documented and properly
ingredients, medical devices, and food. Depending oninvestigated. For the sixth rule, all records regarding
the country where they are utilized, these principlesproduct manufacturing and distribution must be both
can either be guidelines or legally enforced regulations.comprehensible and easily accessed.
Several basic GMP principles exist and are universallyThe seventh GMP manufacturing principle states that
applicable irrespective of industry or country. Firstly,the method of products' distribution should not
manufacturing processes must be clearly defined andreduce their quality in any way. Eighth, in case of
controlled, and all critical processes validated toproblems, any batch should be easily and quickly
ensure compliance with specifications and consistency.withdrawn from retailers. The ninth and last states
The next principle states that any changes to thesethat any complaints regarding products must be
processes need to be evaluated and validated asproperly investigated causes of defects determined,
needed. Third, all procedures and instructions must beand proper measures taken to prevent any
spelled out unambiguously and clearly.recurrence.
All staff members have to be trained not only to