Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) is a framework employed to guarantee consistent production and regulation of products in accordance with prescribed quality standards. Good manufacturing practice is recognized as the fundamental cornerstone of health and safety systems, encompassing a comprehensive set of guidelines delineating the requisite methods, equipment, facilities, and quality controls indispensable for product manufacturing. GMP regulations mandate a quality-centric approach to manufacturing, enabling companies to effectively mitigate or eliminate instances of contamination, mix-ups, and errors. GMP epitomizes an essential prerequisite for the production of wholesome products, as it diligently oversees and directs the entire production process and quality control measures. This encompasses the establishment and maintenance of appropriate production infrastructures, encompassing machinery, environmental conditions, equipment, and a proficient workforce, among other factors.
Basic GMP Guidelines
Establishing a good written procedure
Standard procedures must be clearly defined and performed consistently
Qualify and Validate Processes
validating the system in place and evaluating workers’ performance should be done. It is at this stage that quality testing comes in
Identifying Roles and Responsibilities
With job descriptions lay out and responsibilities, everyone is aware of their tasks
Keeping All Records
Keeping logs and records enable you to track all activities performed during manufacturing operations. The practice of record-keeping allows you to document problems, non-compliance, complaints, and other issues concerning processes
Use the Right Facilities and Equipment
The design and construction of facilities and equipment used should align with the company’s goal of achieving quality products and securing employee safety
Assemble a Competent Team
All workers must be trained to do the job right
Good hygiene
Cleaning the workplace on a daily, basis to help identify hazards and eliminate risk of contamination
Maintain Facilities and Equipment
Regular facilities and equipment inspections are essential to determine if materials are properly maintained or need repair or replacement.
Ensure Quality
Check the quality of materials before using them for production. Ensure that materials are approved and meet product specifications
Parts of a production unit that are under to GMP rules
Production and sales, buildings, equipment and machinery, workers, cleaning, raw material testing, production control, quality control, packaging materials testing, final product testing, sample documentation, complaint handling, product recall.
The US Food and Drug Administration (FDA) formulated the first GMP production guidelines in 1938, and World Health Organization (WHO) the first draft text on good manufacturing practices (GMP) was prepared in 1967
Various countries around the world apply the principles of these guidelines in their laws and regulations and localize them according to their local standards
So the general rules governing GMP are the same in different countries, but its principles may vary slightly according to the laws, regulations and internal standards of each country
In any country, the Food and Drug Administration or legal entities under its authority are responsible for issuing, extending, and revoking this authorization. Generally, depending on government policies, GMP certificates have limited validity for a specified period of time. Authorities may also suspend or revoke a license if the laws and regulations in question are violated