USER REQUIREMENT SPECIFICATION FOR DPI
A User Requirement Specification for DPI is a formal document that defines the requirements for using a system in a regulated environment, such as a pharmaceutical facility. It’s a living document that can be updated as requirements change and is typically prepared in the early stages of procurement. A well-prepared URS can help set the foundation for successful […]
USER REQUIREMENT SPECIFICATION FOR OINTMENTS
A User Requirement Specification Ointments is a document that defines the procurement requirements for equipment. It’s usually written early in the validation process, before the system is created, by the system owner, end-users, and with input from Quality Assurance.
PLACEBO
A placebo is a “physiologically inert substance or sham intervention (psychological, physical or mechanical) which produces beneficial effects independent of any direct therapeutic effects”. The positive effects occur as a result of a patient’s expectations rather than as a result of a causative ingredient. A placebo can be for example be a saline solution, sterile water, or sham […]
ANALYTICAL METHOD VALIDATION IN PHARMA
Analytical method validation in Pharma is a critical process in the development and implementation of methods used for data analysis in various scientific disciplines, including pharmaceuticals, environmental monitoring, food and beverage testing, and clinical diagnostics. This process ensures that the analytical method validation in pharma are appropriate, reliable, and capable of providing accurate and reproducible […]
PRODUCT RECALL
ON JOB TRAINING PROGRAM
MICROBIOLOGY SOP IN PHARMA
Microbiology SOP in Pharma plays important role in pharmaceuticals. Microbiology is the study of microscopic living organisms, such as bacteria and fungi. An applied subfield of microbiology is pharmaceutical microbiology. It entails the research of microorganisms related to the production of pharmaceuticals, such as reducing the number of microorganisms in a process environment, eliminating microorganisms […]
RISK ASSESSMENT FOR DRY POWDER INJECTION
PHARMA BOOKS
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