1. Test facility, organization and personnel 2. Quality Assurance (QA) program 3. Facilities 4. Apparatus materials and reagents 5. Test systems – Appropriate design and adequate capacity of apparatus used for the generation of data – Integrity of physical/chemical test systems – Proper conditions for storage, housing, handling and care –…
The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. The following is a list of traditionally recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.(including) Foods Drugs Biologics Medical Devices Cosmetics…
The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. Company’s website or in commercial promoting a product or treatment some marketers may say their products are “FDA approved.” But how can you…
In recent years, the USFDA focuses on data integrity resulting in a rise in 483 observations and warning letters being issued for data integrity violations. These violations can have serious consequences, including regulatory action, legal consequences, damage to the company’s reputation, and financial losses. Moreover, the FDA has the authority to recall drugs if they…
Maintaining personal hygiene is of utmost importance in any workplace, especially in industries that involve the handling of pharmaceutical products like ampoules and vials. Ensuring proper hygiene during the ampoule and vial filling process is essential to prevent contamination and ensure the safety and quality of the products. Here are some precautions that workers should…
A rapid readout biological indicator (BI) is a tool used in sterilization processes to ensure the effectiveness of the procedure. It provides a quick and reliable way to verify that the conditions required for sterilization have been met. Sterilization is a critical step in many industries, including healthcare, pharmaceuticals, and food processing. It involves…
An agar slant tube (or simply an agar slant) is a screw-capped culture tube partly filled with an agar mix such as nutrient agar, R2A agar, or TSA. To make it a slant tube the agar is allowed to cool with the tube laying at an angle, resulting in a large surface area for…
Sterilization is the practice of “destroying completely all forms of microbial life. Steam autoclaves achieve sterilization by exposing loads to a combination of moisture and heat through direct contact with steam. Microbial death occurs because proteins and nucleic acids in the cell wall rapidly denature at high temperatures. Steam sterilization occurs in three distinct…
