Good Manufacturing Practice Program (GMP) is a system that ensures products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in production that cannot be eliminated through final product testing.
Main Objective:
The primary goal of GMP is to ensure product quality and safety, especially in sensitive sectors such as:
- Pharmaceutical industries (human and veterinary medicines)
- Cosmetics
- Food and beverages
- Dietary supplements
- Medical devices
GMP is based on a simple yet crucial principle: "Quality is not tested into the product, it is built into it". This means that instead of relying only on the inspection of the final product, quality should be built into every step of the manufacturing process.
Basic Principles of GMP:
The GMP system is based on several fundamental pillars, including:
- Documentation
- Facilities and Equipment
- Raw Materials
- Personnel
- Production and Manufacturing
- Quality Control
- Complaints and Product Withdrawal
Why is GMP important?
- To protect consumers: It prevents the sale of unsafe, ineffective, or contaminated products that could cause serious health harm.
- To ensure trust: It builds the trust of regulatory bodies (such as the Food and Drug Administration), healthcare professionals (doctors and pharmacists), and consumers in the product and the manufacturing company.
- Legal Requirement: Applying GMP is a mandatory requirement to obtain manufacturing licenses and market products in most countries of the world.
- Improves efficiency: Structured and documented work reduces waste and errors, enhancing the workflow and efficiency of the production process.
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In summary, the Good Manufacturing Practice (GMP) program is a preventive system that establishes a framework for responsible manufacturing. It is not just limited to rules for cleanliness and hygiene but is a comprehensive quality management philosophy ensuring that every product reaching the consumer is the right product, with the required quality, in the correct dosage, and is safe to use.
