Core Elements of GMP

The Guidance applies to the manufacture of active pharmaceutical ingredients (APIs) for use in human drug products. It is detailed in Table 9.1. 

The first and foremost element for GMP is the quality system. This can be divided into Quality Assurance (QA) and Quality Control (QC). QA is a total system approach. It sets out the compliance policies and procedures for all facets of drug manufacturing. QC is the practical extension of QA. The role of QC is concerned with inspection and testing of environment, raw materials, in-process intermediates, and finished products. 

All personnel involved in GMP production of drugs have to take ownership of quality. It is a requirement that processes and equipment for 

Type of manufacturing Application of the Guidance to steps (shown in gray) used in this type of manufacturing  

Biotechnology Maintenance Cell culture Isolation Physical 

Cell Bank Maintenance and Record Keeping Cell Culture/Fermentation Harvesting, Isolation, and Purification Viral Removal/Inactivation Steps APIs for Use in Clinical Trials General Quality 

Since late 2005, the ICH has added three more quality guidelines Q8— Pharmaceutical Development, Q9—Quality Risk Management, and QIO— Pharmaceutical Quality System. All these guidelines are intended to bolster the quality of drugs to be manufactured, steering manufacturers in the direction to improve compliance, safety, and consistency of the drugs. 

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