Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently
produced and controlled according to quality standards. It is designed to minimize the risks
involved in any production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to
the training and personal hygiene of staff. Detailed written procedures are essential for each
process that could affect the quality of the finished product. There must be systems to provide
documented proof that correct procedures are consistently followed at each step in the
manufacturing process – every time a product is made.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize
or eliminate instances of contamination, mix-ups, and errors. This protects the consumer from
purchasing a product which is not effective or even dangerous. Failure of firms to comply with
GMP regulations can result in very serious consequences including recall, seizure, fines, and jail
GMP regulations address issues including record keeping, personnel qualifications, sanitation,
cleanliness, equipment verification, process validation, and complaint handling. Most GMP
requirements are very general and open-ended, allowing each manufacturer to decide
individually how to best implement the necessary controls. This provides much flexibility, but
also requires that the manufacturer interpret the requirements in a manner which makes sense for
each individual business.
Main Components of GMP
It is paramount to the manufacturing industry to regulate GMP in the workplace to ensure
consistent quality and safety of products. Focusing on the following 5 P’s of GMP helps comply
with strict standards throughout the entire production process.
All employees are expected to strictly adhere to manufacturing processes and regulations. A
current GMP training must be undertaken by all employees to fully understand their roles and
responsibilities. Assessing their performance helps boost their productivity, efficiency, and
All products must undergo constant testing, comparison, and quality assurance before
distributing to consumers. Manufacturers should ensure that primary materials including raw
products and other components have clear specifications at every phase of production. The
standard method must be observed for packing, testing, and allocating sample products.
Processes should be properly documented, clear, consistent, and distributed to all employees. Regular evaluation should be conducted to ensure all employees are complying with the current processes and are meeting the required standards of the organization.
A procedure is a set of guidelines for undertaking a critical process or part of a process to
achieve a consistent result. It must be laid out to all employees and followed consistently. Any
deviation from the standard procedure should be reported immediately and investigated.
Premises should promote cleanliness at all times to avoid cross-contamination, accidents, or even
fatalities. All equipment should be placed or stored properly and calibrated regularly to ensure, they are fit for the purpose of producing consistent results to prevent the risk of equipment
Written by Oludare Akinnuoye (Quality Control Analyst)