Help at hand for drug makers with compliance concerns

By Emilie Reymond

- Last updated on GMT

Related tags Quality systems Pharmacology Pharmaceutical drug

Drug manufacturers having troubles complying with the FDA?s current
Good Manufacturing Practice (cGMP) regulations, may now have the
help they need thanks to a new white paper available on the

MasterControl, a quality management software provider, has just issued a ?white paper? that it claims provides pertinent facts about the US Food and Drug Administration (FDA)?s new guidance ?Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (cGMP) Regulations?, to help pharma companies understand this guidance, and make sure they are covered by it.

In the form of a question-and-answer article, the document covers the main aspects of the guidance, from what it means and who is covered by it, through to how to operate an efficient quality system model.

The FDA recently released this final guidance in order to help pharmaceutical companies run quality systems that are fully compliant with cGMP regulations.

In order to comply with cGMP, pharma companies are required to record, track, manage, store and easily access various production documents and their detailed change history, which can prove tricky because of the complexity of the requirements.

The FDA has come up with this guidance, which is intended to serve as ?a bridge between the 1978 regulations and our current understanding of quality systems.?

The objective is to help manufacturers implement modern quality systems and risk management approaches to meet the requirements of the agency's regulations.

The regulator argues that a well-built quality system should reduce the number of recalls, returned or salvaged products, and defective products entering the marketplace.

For that reason, the guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the cGMP requirements for manufacturing drugs, including biological drug products. The guidance also explains how manufacturers implementing such quality systems can be in full compliance with parts 210 and 211.

cGMP were implemented by the regulator to ensure that the products manufactured by the pharmaceutical and biotech industries meet specific requirements, particularly in terms of quality.

The central feature of the cGMP is that companies are required to test both raw materials and final products for identity, purity, quality, strength and composition.

In other words, this is designed to ensure that the content of a manufactured drug matches the contents of the label.

These regulations are specified in 21 CFR Part 210 (cGMP in manufacturing, processing, packing, or holding of drugs) and 21 CFR Part 211 (cGMP for finished pharmaceuticals).

Pharma manufacturers can find MasterControl?s white paper by clicking >here.

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