HORMONES IN PHARMA
A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of hormone is required to alter cell metabolism. Hormonal preparations are one of the major classes of drugs used […]
USER REQUIREMENT SPECIFICATION FOR OPHTHALMIC
A User Requirement Specification (URS) is a formal document that outlines the needs of a user for a system, product, or service. In the pharmaceutical industry, a URS is a crucial document that ensures that equipment, processes, or systems meet regulatory standards and user needs.
USER REQUIREMENT SPECIFICATION FOR AMPOULES
The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of a GMP clean room design is dependent on a clear and concise User Requirement Specification (URS) to take through a successful Design Qualification (DQ).
ONCOLOGY IN PHARMA
Oncology in the pharma industry is the development and manufacturing of cancer treatments. The term “Oncology” comes from the words “Onco” which means bulk, mass, or Tumor, and “Logy” which means study. Oncology is a branch of medicine that specializes in the diagnosis and treatment of cancer, including preventative medicine and medical oncology. Medical oncology uses drugs such as […]
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 […]
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