GMP for clinical production

As per standard definition, “Good Manufacturing Practice is a system that consists of processes, procedures and documentation that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards.”

Ms. Morales has extensive experience in radiochemistry field, ranging from production to quality assurance (QA/QC) of radiopharmaceuticals as per GMP standards. Since her joining, she has been an integral part of our team. Recently, she shared her thoughts with us about building and maintaining a GMP facility as per regulations promulgated by FDA.

 “The experts say in order to build a GMP facility, there are 5 “P” components that must be considered; People, Products, Processes, Procedures, and Premises. These aspects form strong cooperative ties that keep the facility to drive smoothly,” she expressed, “As a newcomer at the Cyclotron and Radiochemistrty Facility at Stanford, I did realize the utmost importance of GMP that plays a major role to all clinical tracers being released from the facility.”  

“Building a GMP facility is difficult but keeping it in cGMP is way even harder,” she emphasized, “Current Good Manufacturing Practice (cGMP) requires a continuous approach to quality standards using up-to-date technologies in guaranteeing safe and effective products. Clearly, CRF has built a strong measure and commitment to implement cGMP and effectively molds the facility to manufacture its radiotracers to the highest quality standards.”

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