GMP Certification

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.

Pharmaceutical quality affects every American. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for confirming pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Customers expect that each batch of medicines they take will meet quality standards so that they will be effective and safe. Most people, however, are not aware of CGMPs, how FDA declares that drug manufacturing procedures meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs. This paper discusses some facts that may be useful in understanding how CGMPs establish the foundation for drug product quality.

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to confirm that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product, which is not effective or even dangerous.

Good Manufacturing Practices (GMPs) refer to establishing manufacturing procedures, documenting and following these procedures, the training of operators to follow these procedures, and processes for the investigation and corrective actions following deviations from these procedures. The purpose is to ensure the products are manufactured safely and that quality is assured.

Benefits of GMP

Decrease safety risk in product quality and safety.

Allow employees to develop good production / operations habits.

Prove enterprise's management capabilities in product quality, safety assurance.

Improve the international credibility and public image.

Timely detect production and management problems, reduce cost.

Increase client's long-term confidence in the enterprise better understand and comply with the relevant laws and regulations.


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