GMP Guidelines

Pharma IQ

Good manufacturing process (GMP) guidelines are essential to ensure drugs are produced to a consistently high quality. GMP guidelines should be implemented at all stages of the manufacturing process to eliminate the possibility of risks, that may not be detected during clinical trials.

If GMP guidelines are not correctly implemented, there is a risk that poor quality and substandard pharmaceuticals could make it on to the market and potentially cause damage to the health of members of the public. Poor quality medicines also cause governments and individuals to waste their money.

The World Health Organisation (WHO) is a strong supporter of stringent GMP guidelines, without which it claims it would be impossible to ensure that all drugs have been manufactured to the same standards.

WHO GMP guidelines

The WHO identifies a number of possible risks which can occur when GMP guidelines for pharmaceuticals are not correctly implemented.

These include the contamination of manufactured products, damage to public health which may lead to fatalities, and even incorrect labelling which could lead to patients receiving the wrong medication.

If GMP guidelines for APIs are not followed, there is also a risk that the incorrect levels of an active ingredient could be present in medicines, causing treatment to become ineffective or creating adverse effects.

Systems must also be in place to demonstrate that GMP guidelines for pharmaceuticals and GMP guidelines for API have been properly followed.

According to the WHO, the implementation of GMP guidelines is "an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals."

The WHO recommended GMP guidelines are adopted in a number of countries, while a number have harmonised their guidelines including the European Union, the Association of South-East Asian Nations and the Pharmaceutical Inspection Convention.

GMP Guidelines FDA

The United States Food and Drug Agency (FDA) takes the view that GMP guidelines for pharmaceuticals "affect every American".

Current GMP (cGMP) guidelines, as defined by the FDA, require companies to use the most up-to-date systems and practices in order to comply with the regulations.

"Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups and errors ten or twenty years ago may be less than adequate by today's standards," the FDA explains.

However, the FDA stresses that its GMP guidelines for pharmaceuticals, which are flexible to allow each manufacturer to create the most appropriate controls for its processes, are the minimum standards that the pharmaceutical industry should meet.

To ensure that regulations are followed correctly, the FDA sends trained professionals to inspect facilities. The agency also takes reports from members of the public and industry to identify sites for investigation or inspection; however the FDA stresses that "most companies that are inspected are found to be fully compliant with the cGMP regulations".

Guidance on regulations can be gained through the Federal Register and the FDA website. The organisation supplies information on cGMP guidelines through FDA Small Business Representatives and District Offices, which are located throughout the US, and through the Center for Drug Evaluation and Research, Office of Compliance, Division of Manufacturing and Product Quality. The FDA also operates a number of outreach programmes on cGMP guidelines.