Fault tree analysis The fault tree analysis (FTA) was first introduced by Bell Laboratories and is one of the most widely used methods in system reliability, maintainability and safety analysis. It is a deductive procedure used to determine the various combinations of hardware and software failures and human errors that could cause undesired events (referred […]
Failure Mode Effects Analysis (FMEA) Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. “Failure modes” means the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that affect […]
Overview Controlling the storage and issuing of labels and labeling helps prevent mix-ups. Technology, such as bar-codes and vision systems, has reduced the number of label – related recalls, but controlling label storage and issuance is still very important. General Precautions 1. When setting up a program for the packaging operations, particular attention should […]
Recommendation Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This typically at a distance of 15-30 cm from the filter face. Rationale for Recommendation The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g, area where products , product contact packaging components, and product contact surfaces are exposed) is to ensure adequate airflow to protect […]
NIRS combined with appropriate mathematical models and pattern recognition techniques allows analysis of a wide variety of sample types rapidly. Second, NIRS is a non-destructive technique which avoids complex sample preparation by chemical or physical processes. In fact, both solid and liquid samples in different types of packaging stored under different conditions can all be […]
It’s generally nerve-wracking when the US Food and Drug Administration (FDA) shows up at your door for an inspection. Even if you’re confident that everything is in good shape around every corner. To ensure compliance with regulations, the FDA conducts inspections of all registered establishments. Once the inspection is closed out, it is categorized in […]
Requested By: for KVR SudhirOrganization: PharmaceuticalsCategory : Parenterals Questions A. VIAL WASHING MACHINE QUESTIONS 1. What is purpose of vial washing machine? Objective: Cleaning of Vial externally and internally to reduce the bio-burden. Note: It is used as a primary packing material. 2. Why compressed air and recirculated water used for washing? Compressed air used […]
The control and monitoring systems are considered the core of the environmental control system. The final performance of the environmental control system can be evaluated only after these have been validated. PQ protocols covering this system, in general, include the performance challenges for the all the components of the environmental control system described in the […]
The United States Food and Drug Administration (FDA) defines a Warning Letter as “…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be […]
GMP Question and Answers Why is GMP important?Poor quality medicines are not only a health hazard, but a waste of MONEYfor both governments and individual consumers. Poor quality medicines can damage health?A poor quality medicine may contain toxic substances that have been unintentionally added.A medicine that contains little or none of the claimed ingredient will […]
