In pharmaceutical cleanrooms, a cross-over bench serves as a physical and procedural barrier between different cleanliness zones, such as “unclean” (gray areas) and “clean” areas. Prevent Contamination: Ensures that particles, microorganisms, or dirt from street footwear or garments ...

1.0 Purposes: 1.1 Lay down the standard operating procedure for the entry-exit procedure in pharmaceuticals. 2.0 scope: 2.1 This SOP applies to all personnel, including visitors entering or leaving the production area of the main plant. 3.0 Responsibility: 3.1 All personnel entering and leaving the production ...

In the pharmaceutical industry, water conductivity is a measurement of the amount of dissolved ions in a water sample, and is used to determine the purity of water. Using a conductivity meter to measure the conductivity of water sample. The meter applies a voltage across two electrodes immersed in the ...

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 ...

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 ...

The 5 Whys method is a root cause analysis tool that helps determine the root cause of a problem by asking the question “Why?” five times in a row. The answer to each question forms the basis for the next question. The goal is to dig deeper to ensure corrective action goes beyond addressing ...