Pharma Definition/Abbreviation, Pharma Beginners
Cleaning validation guidelines provide a systematic approach to proving that cleaning procedures consistently and effectively remove product, cleaning agent, and microbial residues from equipment to acceptable levels. Key steps include creating a detailed validation protocol with a risk assessment, defining acceptance criteria, selecting worst-case products, establishing validated analytical methods, and performing sampling and testing (swab or rinse).
ISO 9001:2015 is an international standard for a quality management system (QMS) that helps organizations consistently provide products and services to meet customer and regulatory requirements.
The PDCA (Plan-Do-Check-Act) cycle is an iterative, four-step process for continuous improvement of products and processes. It involves planning a change, doing the change on a small scale, checking the results, and acting on the learnings by standardizing or making further adjustments.
The “5 Whys” is a problem-solving technique used to identify the root cause of an issue by repeatedly asking “why?” to get to the bottom of the problem.
It involves starting with a problem statement and then asking “why” five times, with each answer forming the basis for the next question. The process is designed to move past surface-level symptoms to uncover the underlying cause.
Quality Assurance vs Quality Control
FMEA techniques involve a systematic, step-by-step process to identify potential failure modes in a product or process, analyze their effects, and calculate a Risk Priority Number (RPN) to prioritize actions.
𝑅𝑃𝑁=𝑆𝑒𝑣𝑒𝑟𝑖𝑡𝑦×𝑂𝑐𝑐𝑢𝑟𝑟𝑒𝑛𝑐𝑒×𝐷𝑒𝑡𝑒𝑐𝑡𝑖𝑜𝑛
