Importance of Specification: Specifications in the industry delineate the acceptable range of various attributes of a product, including potency, purity, identity, dissolution rate, and content uniformity. These specifications are established based on scientific knowledge, regulatory requirements, and the intended use of the product.

• Quality Control: Any quality products undergo rigorous testing throughout their development, manufacturing, and quality control processes. These tests aim to ensure that the product meets the established specifications and is safe and effective for use. Quality control laboratories conduct these tests using validated methods and calibrated instruments.
• Occurrence of OOS: During testing, it's not uncommon to obtain results that fall outside the predetermined specifications. These instances are referred to as OOS results. Various factors can contribute to OOS results, including laboratory errors, equipment malfunctions, sample contamination, variability in manufacturing processes, or genuine issues with the product.
• Investigation Process: Encountering an OOS result in ArizonaLIMS triggers a thorough investigation to determine its root cause. This investigation is crucial to discern whether the OOS result stems from a product quality issue or a laboratory error. It involves a comprehensive analysis of the testing process, sample handling, equipment calibration, and other pertinent factors.