Glossary Definition: Good Manufacturing Practice (GMP)

What is good manufacturing practice?

Good manufacturing practice (GMP) is a system that ensures products are manufactured according to specific quality standards. These standards are designed to guarantee product purity and reduce the likelihood of unsafe products entering the market.

GMPs take into consideration and analyze a number of processes related to raw materials, sanitation and hygiene, quality management, documentation, inspections, and audits, equipment, and premises.

Industries that abide by good manufacturing practices include: 

  • Pharma
  • Medical devices 
  • Biotech
  • Food and beverage products

Essentially, most products that people consume — either directly or indirectly — must adhere to GMPs.

GMP vs cGMP: What’s the difference?

Good manufacturing practices are processes designed to ensure the safety and quality of products. In contrast, current good manufacturing practices (cGMP) refer to the evolving technologies and systems companies must use to comply with GMP regulations.

Both GMP and cGMPs work hand in hand and prioritize product quality. However, cGMPs specifically focus on the continuous improvement of quality, via technological advancements.

What are the 5 main components of GMP?

GMP comprises five main components, often referred to as “five Ps.” These include:

  1. Products: Raw ingredients/materials 
  2. People: Professionals trained in compliance 
  3. Processes: Following and documenting every step
  4. Procedures: Guidelines to accurately and safely complete a process 
  5. Premises: Labs, equipment, and buildings used for manufacturing

GMP analyzes every “P” to ensure the products adhere to quality standards, the people are following regulations, all processes and procedures are followed to a tee (and documented accordingly), and the premises are safe and sanitary.

What is good manufacturing practice in pharma?

In pharma, good manufacturing practices refer to the processes in place that minimize risks associated with drug manufacturing. GMPs adhere to stringent Food and Drug Administration regulations. The purpose is to ensure medications meet quality standards and deliver on their promise to be safe and effective.

Why is GMP important in pharma?

Good manufacturing practices are important in pharma because they ensure the safety, quality, and consistency of drugs. In the absence of GMPs, it’s likely unsafe products would enter the market — either due to contamination, unintentional deviations, or human error.

GMPs minimize preventable risks associated with digital manufacturing (DM) and drug consumption. And they help ensure that every time a patient picks up their prescription — no matter what pharmacy they go to — the ingredients, processes, and potency of the final product is the same.

In an effort to continuously improve quality and output, many pharma companies are turning towards cloud-based MES solutions. These systems allow users to:

  • Record processes in real time
  • Notify supervisors of any deviations as they occur
  • Safely scale up drug manufacturing to increase output

Ultimately, GMPs ensure product quality with the goal of protecting consumers by adhering to rigorous standards. These standards reduce the likelihood of unsafe products entering the market and streamline the entire manufacturing process from start to finish.