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…
1. Establish a robust CAPA process: Implement a well-defined and documented Corrective and Preventive Action (CAPA) process that is aligned with regulatory requirements. 2. Train employees: Provide comprehensive training to employees on the CAPA process, including how to identify and report issues, and how to implement effective corrective and preventive actions. 3. Foster…
Every pharmaceutical manufacturer must have and implement suitable processes for dealing with deviations from processes and quality specifications in order to continuously ensure the required quality of the products. There are many reasons for deviations. They range from quality problems in the raw materials, materials, equipment and devices used to inadequate description or implementation…
1. Corrective action A systematic process undertaken to identify, analyze, and eliminate the root cause of a nonconformity or deviation in order to prevent its recurrence. 2. Preventive action Proactive measures taken to identify and eliminate potential causes of nonconformities or deviations before they occur. 3. Nonconformity Any deviation from established standards, procedures,…
The concept of the Qualified Person (QP), first established in 1975, is a unique regulatory requirement which applies within the European Union (EU). The only comparable situation exists within Member States of the European Economic Area (EEA) with whom the EU has reciprocal agreements. Each holder of an Authorisation to Manufacture products…
Managing deviations and investigations efficiently is critical to ensuring product quality, compliance with regulations, and continuous improvement. An effective quality management system (QMS) must include procedures to identify, document, segregate, evaluate, and disposition production and post-production issues. You need to report and document the deviation as soon as it is identified. This includes…
There are several quality risk management trends in the pharmaceutical industry that have emerged in recent years. These trends aim to improve the overall quality and safety of pharmaceutical products and processes. Some of the key trends include: 1. Implementation of Quality by Design (QbD): QbD is an approach that focuses on building quality…
