Sterility testing is a microbiology laboratory test that assesses if a product is free of viable microorganisms, or sterile. It’s performed on manufactured biological materials, such as blood products, pharmaceutical products, and sterile medical devices. The industry standard for sterility testing ...

Cleaning validation establishes that the cleaning procedure can effectively remove product residue from pharmaceutical equipment to an acceptable limit. Cleaning validation is a critical step in the pharmaceutical manufacturing process that ensures the safety of patients by preventing cross-contamination ...

Microbiological test that evaluates the ability of aseptic manufacturing personnel to prevent contamination during drug production. The test uses a sterile microbiological growth medium, such as Triptic Soy Broth (TSB), to assess the technique and competency of personnel to perform tasks such as filling, ...

CAPA stands for Corrective and Preventive Action, and is a quality management system that involves identifying, analyzing, correcting, and preventing issues. It’s an important part of a pharmaceutical company’s quality management system, and helps to prevent problems from recurring. CAPA ...

The pharmaceutical industry is poised for significant changes in 2024, driven by technological advancements, regulatory shifts, and evolving market dynamics. Here are some key trends to anticipate: 1. Continued dominance of small molecule drugs Small molecule drugs are expected to continue to dominate ...

Cleaning validation establishes that the cleaning procedure can effectively remove product residue from pharmaceutical equipment to an acceptable limit. Cleaning validation is a critical step in the pharmaceutical manufacturing process that ensures the safety of patients by preventing cross-contamination ...

Line clearance is a crucial process in the pharmaceutical industry that ensures the safety and quality of products being manufactured. It involves a thorough inspection and verification of equipment, facilities, and materials before starting a new batch production or after completing a batch. The line ...

Root cause analysis (RCA) is a structured method for identifying the main cause of a problem and implementing changes to the system. It’s an important part of CAPA (Corrective and Preventive Actions) management in the pharmaceutical industry. RCA is used to determine the underlying cause of a ...

Microbial data deviations occur when the results of microbial tests fall outside of the product specifications or acceptance criteria. These deviations are also known as “out-of-specification” or “out-of-limit” results. The purpose of a microbiological data deviation investigation ...

Kaoru Ishikawa, a Japanese quality control expert, invented the fishbone diagram, also known as an Ishikawa diagram, in 1945. The diagram is named after its creator and resembles a fish skeleton, with the “ribs” representing the causes of an event and the final outcome appearing at the head ...