Pharma Blog
DOSTINEX (Cabergoline) | Drug Digest
DOSTINEX (cabergoline) works by acting on the pituitary gland which is located at the base of the brain. By stimulating this gland, it prevents the production of the hormone prolactin. DOSTINEX is indicated for: 1. Treatment of hyperprolactinemic disorders: DOSTINEX is indicated for the treatment of hyperprolactinemic disorders, either idiopathic ... Read More
Nicotine Gum | Effectively Relief Your Cravings
Nicotine Gum comes in 2mg or 4mg so you can choose the right strength based on how much you smoke. Nicotine is absorbed quickly through the lining of your mouth helping to effectively relief your cravings. What strength you need to use? How to use the gum? Ask your doctor ... Read More
Audits and Inspections in Pharmaceutical Industries | Similarities and Differences
Audit: ensure quality and compliance with systematic, independent examination and documented process Inspection: determination of conformity to specified requirements “Audit” can be seen as an umbrella term, whereas “inspection” is one concrete type of audit. Similarities 1) Both involve a review of processes, procedures, and records.2) Both aim to determine ... Read More
Computer System Validation in Pharmaceutical Industry
CSV is the process of testing/validating/qualifying regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper-based records. The validation process begins with planning, system requirements definition, testing and verification activities, ... Read More
Common Terms Used in USFDA Inspections
Types of USFDA Inspections The agency also conducts inspections to verify the reliability, integrity and compliance of r&d facilities, testing labs, cmo, clinical and non-clinical research being reviewed in support of pending applications. FDA Forms 482, 483 and 484 Establishment Inspection Report (EIR) A comprehensive report that provides a detailed ... Read More
Patents and Exclusivities | Differences and Importance
Patents Property right issued by USPTO to an inventor “to exclude others from making, using, sale, import the invention into the US for a period of 20 years from the date of filing”. Patents can be issued or expire at any time regardless of the drug’s approval status Patent information ... Read More
Environmental Monitoring in Pharmaceutical Industry
Environmental monitoring in the pharmaceutical industry is a crucial process that involves the regular assessment and control of various environmental factors within a pharmaceutical manufacturing facility. This monitoring is essential to ensure the safety, quality, and efficacy of pharmaceutical products. The pharmaceutical industry operates under strict regulations and guidelines to ... Read More
Methods of Sterilization and Depyrogenation
Methods of Sterilization Heat Sterilization This method involves the use of high temperatures to kill microorganisms. It can be achieved through: Radiation Sterilization This method uses ionizing radiation, such as gamma rays or electron beams, to destroy microorganisms. It is commonly used for sterilizing medical equipment, pharmaceutical products, and certain ... Read More
Guidelines on Good Distribution Practice of Medicinal Products
Quality Management The organisation’s management is responsible for the quality system, which requires their leadership and active participation supported by staff commitment. The Responsible Person is to ensure that a Quality Management System is implemented and maintained. The Management is to ensure that all parts of the quality system are ... Read More
Predictive Maintenance and Machine Learning in GMP Facilities
Predictive maintenance (PdM) is a general method that uses ongoing analysis of operational data to determine when equipment maintenance will be required. When applied appropriately, it can reduce maintenance expenses while improving reliability. Maintenance of GMP facilities is necessary to ensure that they operate in a qualified and validated state ... Read More
Difference Between OOS and Deviation
OOS (Out of Specification) and deviation are terms commonly used in the context of quality management, particularly in pharmaceuticals industries. Here’s a brief overview of each term: Out of Specification (OOS) Definition: An OOS result occurs when the test results of a sample fall outside the established acceptance criteria or ... Read More