Skip or Periodic Testing Periodic or skip testing is the performance of specified tests at release on pre-selected batches and / or at predetermined intervals, rather than on a batch-to-batch basis with the understanding that those batches not being tested still must meet all acceptance criteria established for that product. This represents a less…
OOS is a term commonly used in the pharmaceutical industry to describe a situation where a test result of a pharmaceutical product, material, or sample falls outside the predetermined specifications or acceptance criteria. An OOS result indicates that the product or material may not meet its intended quality standards and could potentially pose risks…
OOT in pharmaceutical analysis refers to a situation where a pharmaceutical product or process parameter falls outside the expected or established trend over time. Trends are usually established through a series of measurements or tests conducted during product development, manufacturing, and quality control. These trends help ensure consistency and quality of pharmaceutical products. Deviations…
The main similarities and differences between Quality Control (QC) and Quality Assurance (QA) are as follows: Similarities 1. Both quality control and quality assurance are essential components of the pharmaceutical industry. 2. Both aim to ensure that pharmaceutical products meet the required standards and regulations. 3. Both involve monitoring and evaluating processes to identify any…
