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GMP Certification

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

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.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, observing, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and pureness of drug products by needful that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating processes, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, supports to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

The CGMP necessities were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary panels by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations permits companies to use modern technologies and innovative approaches to achieve higher quality through continual enhancement. Accordingly, the "C" in CGMP stands for "present," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.

It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already applying comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

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