In the pharmaceutical industry, both generic (ANDA) and 505(b)(2) submissions are key regulatory pathways, but they serve different purposes. Generic (ANDA): This is for drugs that are bioequivalent to an already approved product. ANDA submissions must show the drug is the same in dosage, form, strength, and administration route as the reference drug. No new…
Prepare Safety Sanitize Drain Rinse Collect Label Store Read also: Resource Person: Syed Masood
In the pharmaceutical industry, temperature-controlled incubation plays a crucial role in microbiology labs to ensure the growth and testing of microorganisms for quality control, product safety, and regulatory compliance. Different incubation temperatures are selected based on the type of microorganism being studied and the purpose of the test. Incubation Temperatures in the Pharmaceutical Industry Bioburden…
Environmental monitoring (EM) in the pharmaceutical industry is a critical component of quality assurance, ensuring that the manufacturing areas, especially those dealing with sterile products, meet regulatory standards. It involves monitoring the cleanliness and microbial contamination levels of air, surfaces, and personnel in controlled environments like cleanrooms. Here are the key aspects: Purpose of Environmental…
How can the effectiveness of isolator systems and Restricted Access Barrier Systems (RABS) be evaluated in a specific production environment before and after implementation? Evaluating the effectiveness of isolator systems and Restricted Access Barrier Systems (RABS) in a production environment requires a detailed and systematic approach, both before the systems are put into place and…
A buoyancy test is required in cleanroom Laminar Airflow Systems (LAFs) to ensure proper airflow and contamination control. Cleanrooms are designed to maintain extremely low levels of airborne particles, and LAF systems play a critical role by providing a continuous, unidirectional flow of filtered air. The buoyancy test helps in verifying the following: Airflow Patterns:…
Smoke Study is used to maintain the aseptic conditions when manufacturing sterile products. When we are manufacturing sterile products, we have to maintain aseptic conditions under the laminar airflow. So, how to ensure that the airflow is proper? We cannot see air, but we can see smoke. Smoke is used as a visual aid, a…
Radiation is a non-thermal sterilization method that destroys microorganisms in a product with gamma radiation, beta particles (electron beam), or ultraviolet light. Other than sterile filtration, radiation is the only other sterilization method that doesn’t rely on elevated temperature in order to sterilize. Radiation is an excellent alternative for products that cannot be sterilized with…
