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 […]
How to calculate conveyor speed in Tunnel? Dry heat is used for sterilization instead of the much more efficient moist heat because some materials are sensitive to moisture. Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material. The process of sterilization within a chamber or hot […]
Stability – Definition: How the quality of an API or FPP varies with time under factors such as temperature, humidity and light.Studies also show how product-related factors influence stability: the properties of API/excipients, FPP composition, manufacturing process, and container-closure system. API: Active Pharmaceutical IngredientFPP: Finished Pharmaceutical Products Stability – purpose: a) To establish a re-test […]
Here we are providing the information that what are the precaution you need to be taken during giving any pharmacy registration and how to take relieving from medical shop. It is myself experience. Do’s Prepare an agreement that how many year (minimum 5 to maximum 10 year) you want to engage with medical shop (shop […]
Definitions:AQL: The AQL is the maximum percentage defective (or the maximum number of defects per hundred units) that can be considered satisfactory as a process average.Nonconformity : Non fulfillment of a specified requirementDefect: Non fulfillment of an intended usage requirement Nonconforming item: item with one or more nonconformity. Sampling Plan:NORMAL inspection shall be initially. AQL level consider as […]
Among the health care professionals, pharmacists are considered as major pillars in design, development and supply of quality medicines to the patients. The development of pharmaceuticals/formulations is an outcome of interplay between pharmaceutical and medicinal chemistry (especially synthetic and phytochemistry), pharmaceutics and pharmaceutical technologies, analytical techniques and quality assurance at each and every level. Along […]
Building Management System (BMS) is monitor and control the parameters of HVAC system like temperature, relative humidity and air quantity to maintain a controlled environment.
Selection of Glass compatibility with drug product is major issue in Sterile Pharmaceutical practice. Physical and & Chemical stability is the major issue. Wrong selection of glass type caused breakages during Lyophilization, washing, DHS etc activity. “ As per 21CFR211.94 Drug product containers and closures: (a) Drug product containers and closures shall not be reactive, […]
