What Are The Current Good Manufacturing Practice?

Good manufacturing practice, GMP, is a set of guidelines or systems implemented to keep manufacturers in line, guaranteeing that their products meet a certain quality standard. With good manufacturing practice in place, companies and organizations are bound by specific rules that ensure that their products are manufactured in a controlled way and that it meets specific quality standards.

GMP highlights some basic preventive guidelines that must be strictly followed by factories and facility operations. Being an essential part of the quality control process aimed at maintaining high manufacturing standards, GMP also minimizes risks that can’t be eliminated through testing of the final products.

Factories and manufacturers in the drug and pharmaceutical industries are bound by the practices and guidelines that are put together by regulatory agencies to ensure that the final products released to consumers are those that meet the highest quality health and safety standards.

What is Good Manufacturing Practice?
According to Safeopedia.com, Good manufacturing practice, GMP, refers to systems devised to ensure the consistent production and control of manufacturing following pre-determined quality standards. It covers all aspects of manufacture from raw materials to the manufacturing premises and staff activities.

Changes in Good manufacturing practices
Good manufacturing practices are subject to changes based on the latest information that has been made available to regulatory bodies and agencies.

Employees need to stay updated with these changes as this is the only way to maintain compliance and ensure quality control labels remain effective.

Changes in good manufacturing practices are often necessitated by changes in methods and other factors, and this is why, for some, GMP is commonly referred to as CGMP, Current Good Manufacturing Practices.

The Current Good Manufacturing Practices requires that companies remain updated in common areas, including:
Environmental protection i.e., prevention of environmental contamination.
Hygiene.
Product distribution methods.
The control of the manufacturing process to meet the highest quality standards.
Control of procedures and record-keeping.

Investigation of compliance with GMP rules and regulations as well as deviation from guidelines.
Procedures to follow for drug recalls and defect investigation process.

The regulatory practices a company or manufacturer is subjected to depends on where the company is located and the industry in which it operates. This means that the same regulation and guide may not apply to any two sectors, say, construction industry and pharmaceutical industry.

Consumption of food and drugs
The guidelines set as part of good manufacturing practices are aimed at ensuring that food and drugs meet the highest possible safety and health standards for human consumption. To ensure this, GMP has set guidelines that manufacturers must obey with regards to manufacturing, testing, and quality assurance.

There is an increasing call by many countries to ensure that manufacturers in the food, pharmaceutical, and medical device industries meet up to the highest quality GMP procedures and guidelines that correspond to the updated legislation.

GMP for food and drugs
GMP for food and drugs aims to ensure that manufacturers comply with the highest standards to ensure that consumer’s health is not put at risk. This also places strict rules on drug testing, as in some cases, a drug that has passed all examination may still be classified as ‘adulterated’ if it fails to adhere strictly to GMP guidelines.

Regulatory Agencies enforcing Good Manufacturing Practice
The United States boasts of the Food and Drug Administration (FDA), a body that enforces GMP under Title 21 CFR. The FDA regulates all products that are classified as food, drugs, cosmetics, tobacco products, and medical devices.

In the European Union (EU), national regulatory agencies have the authority to enforce GMP guidelines and also to perform GMP inspections.

Canada has the Drug Good Manufacturing Practice Unit as well as the Health Products Food Branch Inspectorate to oversee the enforcement of strict GMP guidelines.

India also put in place a state-level agency, Foods and Drug Administration (FDA), to oversee GMP inspection while reporting back to the Central Drugs Standard Control Organization.

Leave a Comment

Your email address will not be published. Required fields are marked *