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 ...

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 ...

1.0 OBJECTIVE: To lay down a procedure for Laboratory Cleaning. 2.0 SCOPE: This SOP shall be applicable to Chemical & Instrument section of Quality Control Laboratory. 3.0 RESPONSIBILITY Execution – Laboratory Attendant Checking – Executive and all above 4.0 ACCOUNTABILITY Manager Quality ...

A Pareto chart is a tool that helps identify and prioritize problems and allocate resources. It is a type of chart that combines bars and a line graph to visually represent the frequency of issues and their cumulative percentage. The Pareto chart is based on the Pareto principle, also known as the ...