What You Need to Know About Good Manufacturing Practices (GMP)By David Thompson, UniversityHerald Reporter
Companies that make consumable products, such as food, drugs, and cosmetics, must follow certain rules to ensure the safety of their products and the well-being of their customers.
These rules are set forth by various organizations and governmental agencies and are referred to as Good Manufacturing Practices (GMPs). This article will discuss GMPs and what you need to know to become GMP certified.
Let us explore:
The definition of GMP
Good manufacturing practices, or GMPs, are the guidelines for ensuring that products and ingredients are produced and packaged safely. The FDA requires GMPs for food and drug manufacturing facilities in the U.S.
The FDA published the first edition of the Current Good Manufacturing Practice (CGMP) regulations in 1979; these regulations were revised. Current good manufacturing practices were coined because they were designed to be updated as science evolves.
Who can issue a GMP certificate?
An accredited certification body can issue a GMP certificate in accordance with the requirements of the regulatory authorities.
The FDA has also approved the National Quality Standard for GMPs, which is a private sector initiative to provide a quality management system standard for manufacturers that want to demonstrate compliance with FDA requirements.
What are CGMPs?
CGMPs are guidelines detailing how a company should produce its products to ensure that the product is safe for use. The guidelines cover everything from the manufacturing process to quality control and sanitation.
The FDA oversees CGMPs and requires adherence for a company's products to be eligible for local use or export.
CGMPs are especially important for pharmaceutical companies because one mistake can cost lives.
There are two levels of CGMP certification in the United States: Good Manufacturing Practices and Current Good Manufacturing Practice Regulations.
If you have a question about what this means for your business, please consult with someone knowledgeable about these regulations to be on the safe side.
The Responsibilities of Producers and Importers
Producers and importers are responsible for ensuring that their products comply with GMP by:
Establishing, implementing, and maintaining an adequate quality management system per the requirements of the GMP certificate.
Identifying, evaluating, and controlling the risks associated with their products throughout the manufacturing process.
Ensuring that the facilities where the product is manufactured comply with GMP at all times by establishing procedures for routine monitoring of production processes and control of non-conformities; corrective actions; verification activities; acceptance tests; complaint handling; maintenance of records (including complaints) and reports on the compliance status of facilities, as appropriate.
The Responsibilities of Manufacturers
Manufacturers are responsible for ensuring their products are safe for humans and the environment. This includes ensuring that raw materials, ingredients, and finished goods are safe and conducting quality assurance procedures such as testing and inspections.
They are also responsible for safety, health, and environmental management systems which are required by law in many countries.
It is important for manufacturers to follow good manufacturing practices (GMP) to produce a high-quality product that meets customer expectations. GMP guidelines cover everything from the design of a facility, equipment, and processes used in the manufacturing process up to packaging labels.
There are six key elements to consider when it comes to GMPs:
Hazard analysis and risk-based preventive controls
Management of change
Quality records maintenance
Production and process controls
Why are GMPs so Important?
Good Manufacturing Practices are a set of regulations and guidelines that govern how products are manufactured. The goal is to create a safe environment for the employees and ensure that raw materials don't contaminate any finished products.
Each GMP Standard has its own purpose, but they're all in place for one reason: to protect the consumer. Not only do these standards help maintain a healthy workplace, but they also help keep harmful toxins out of your food and other products.
There are different standards:
Here's what you should know about each one:
Purchasing and sourcing
Incoming material control
Production process control (includes items such as equipment maintenance and good manufacturing practices documentation requirements)
Testing and lab controls
Control of non-conforming product or process deviation (includes recall management procedures)
Corrective action (includes identification and documentation procedures).
Difference between GMP and cGMP
There are some key differences between GMP and cGMP. For starters, cGMP is a set of guidelines created by the U.S. FDA, while GMP is more of a general guideline covering all aspects of manufacturing in any country.
In addition, cGMP is voluntary, whereas GMP is mandatory for products being sold within the United States and other countries.
Finally, a major difference between the two is that one way of demonstrating compliance with cGMP guidelines may be through an FDA inspection. Still, there are no requirements for how to demonstrate compliance with GMP guidelines. As you can see, there are many similarities and significant differences between these two types of guidelines for manufacturers.
Is GMP a legal requirement?
GMP is a legal requirement in the United States. However, it is a requirement for FDA-regulated products and is also required by other countries. The purpose of GMP is to help manufacturers control the quality of their products by providing standards for how they should be made. These standards can include manufacturing processes, facility management, packaging, and labeling.
The Final Thought
Good manufacturing practices are a set of guidelines that are followed when producing a product. They ensure the safety of the consumer and can be applied to any industry. The FDA is responsible for ensuring GMPs are being followed and enforcing penalties if the guidelines are not adhered to.
There are four main areas in which GMPs should be addressed: personnel, premises, equipment and procedures, and quality assurance. GMP personnel should have an educational background or experience in pharmaceutical sciences or biological sciences; they should also have previous experience with good manufacturing practices. When it comes to premises, all surfaces must be cleanable, and there must be no cross-contamination between products. All equipment should be inspected before use and kept up-to-date according to their expiration date.