viernes, 27 de julio de 2018

What is Good Manufacturing Practice (GMP)?

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By Hannah Simmons, BSc

The Good Manufacturing Practice (GMP) guidelines are a set of regulations that ensure that food, drugs, medical devices, and cosmetics are produced at a high quality.

Image Credit: Gorodenkoff / Shutterstock

GMP guidelines encourage manufacturing companies to guarantee their goods are consistently produced within safe environments in accordance with strict protocols, thereby reducing possible contamination and manufacturing errors.

Origins of Good Manufacturing Practice (GMP)

The World Health Organization (WHO) has established GMP guidelines in detail from which many countries have formulated their own GMP.

Some of the major GMP regulation agencies are US (Code of Federal Regulations), Europe, Canada, Brazil, Australia, United Kingdom, Germany, and South Africa. Of all the GMPs, the most frequently referenced are the US cGMP (current GMP), the European Union guide to GMP for medicinal products, International Conference on Harmonization (ICH) Q7 GMP guide for active pharmaceutical ingredients (API), and the WHO GMP (2003).

In the USA, these regulations are enforced by the U.S. Food and Drug Administration (FDA), as written in Section 501(B) of the Food, Drug, and Cosmetic act of 1938.

Failure to adhere to GMP regulations can lead to serious consequences such as recall of products, hefty fines, or even imprisonment.

GMP within drug production

GMP is particularly important within the field of drug development, as even small errors can lead to serious medical consequences.

GMP helps to reduce several common errors such as drug contamination (which may be harmful or even fatal), incorrect labeling, and inconsistent dosages forms (which could lead to overdose or ineffective treatments).

The production process is highly controlled, ensuring that the final product is safe for use and functions effectively.

The main rules of GMP in drug production

These guidelines are highly comprehensive, covering the starting materials, the health, and safety training of the staff, and the equipments used. The main rules are listed below:

Trained and efficient staff should carry out and record the manufacturing processes.
Facilities must be cleaned and high standards of hygiene and quality must be maintained from procurement to product.
Cross-contamination must be prevented by temperature and humidity-controlled environments and by restricting entry to authorized staff with proper work gear.
Manufacturing processes must be written out in a clear and lucid manner. This document is called the “standard operating procedures (SOP)” document. Each stage must be validated and optimized.
Each step of manufacture must be recorded.
The quality and amount of drug product must be recorded.
The distribution of each batch must be documented to allow traceability.
Any deviation from the SOP must be investigated and recorded.
Distribution must be carefully carried out to prevent damage and maintain quality of the drug.
Complaints must be investigated, and efficient contingency plans must be put in place to handle situations such as the need for a drug recall, or updating a drug label, and so on.

These GMP guidelines are flexible and open-ended allowing each manufacturer to implement them to suit their manufacturing needs.

The future of GMP

GMP guidelines are strict guidelines that are in place to protect the interests of the customer by ensuring delivery of high quality and effective products. Currently, the FDA emphasizes quality by way of design rather than quality by testing.

The pharmaceutical industry is focusing on improving the manufacturing efficiency and regulation of quality by using applicable science and engineering principles.

The application of science and engineering principles can not only assure consistent quality of a product but also helps in executing adequate risk management plans to mitigate the chances of producing poor quality products.