Step 1: Identification of the Hazard Hazard Identification is a critical step in Risk Analysis. Many aids are available, including experience, engineering codes, checklists, detailed process knowledge, equipment failure experience, hazard index techniques, What-if Analysis, Hazard and Operability (HAZOP) ...

Las empresas deben seguir ciertas prácticas clave para el cumplimiento continuo de las inspecciones y regulaciones de la FDA. Las siguientes mejores prácticas deben implementarse para cumplir con las pautas regulatorias 1. Desarrollo de un Sistema de Gestión de la Calidad: Como mencioné anteriormente, ...

Human errors have a serious impact on the quality of pharmaceutical products. About 80% of product quality problems are caused by human error. Human errors are identified when deviations occur in the process. Most of the root causes of deviations are human error due to improper communication or failure ...

During the inspection, FDA inspectors will assess compliance with FDA regulations and try to find issues that may affect product quality. The inspection finding can vary with companies and inspectors, but below are common findings to be aware of. Inadequate documentation is the most common finding. Inspectors ...

MSDS means Material Safety Data Sheet and it contains 16 contents. Those are given below: 1. Product Identification 2. Composition / Information on Ingredients 3. Hazards identification 4. First Aid measures 5. Fire fighting measures 6. Accidental release measures 7. Handling & storage 8. Exposure ...

General Instructions = Check the general environment in the department. = Ensure proper gowning by the personnel in concerned work area. = Check for the daily calibration of balance. = Check the calibration status label of machines. = Ensure that the line clearance is obtained before starting the next ...

Definition of Reprocessing: = The operation which is to be undertaken for all or part of a batch of product of an unacceptable quality from a defined stage of production, so that its quality may be rendered acceptable by one or more additional operations. = For reprocessing situations, thorough investigations ...

Contamination control for pharmaceutical manufacturing is an essential factor in the overall success of a pharmaceutical product. This article reviews some pollution control strategies for controlling microbial growth, including environmental control, worker protection, and medical waste management. The ...

A recent report by the US Food and Drug Administration (FDA) showed an increase in investigations of off-specification products in the pharmaceutical industry. The FDA cites deterioration in quality control as a major cause of these problems. As the industry transitions to novel and more complex products, ...

Testing is done at the factory where the system is called FAT. The purpose of this test is to ensure that the system functions according to its operational requirements given in the URS. A cross-functional team from the user side will visit the factory to see it. The vendor then demonstrates the performance ...