The Medicines and Healthcare Products Regulatory Agency (MHRA) is a government agency in the United Kingdom. MHRA’s prime role is to regulate medicines, medical devices, and blood components for transfusion in the UK. MHRA guidelines are very important recommendations for…
A stability chamber works on the principle of maintaining the relative humidity (RH) and temperature of the chamber with the help of thermostats and water reserved in the chamber. As per the law of physics, the air can maintain…
Principle of autoclave The autoclave functions to sterilize the subjected material by generating steam pressure inside the chamber at a standard vaporizing temperature, maintaining the conditions for a certain time frame. The whole process is moist heat sterilization which is…
USFDA approval is a big milestone for any pharmaceutical manufacturing facility. If you are looking to export medicines to the US then you must have your facility approved by the USFDA. A pharma company can only sell direct products in…
FDA guidelines for high-purity water system The FDA guidelines are dominating the aspect of microbiological conditions of water for injection and purified water systems that are used in the manufacturing of drug products. The guideline also covers the different types…
Quality assurance and Quality control both terms seem very similar in general but are very different in view of the roles they play in a company. In pharmaceutical manufacturing companies, both QA and QC have predefined roles and functions. These…
Title 21 CFR and Its Recommendations The title 21 CFR is a part of the Code of Federal Regulations (CFR) permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. It is allocated…
Top 5 pharma companies in USA|Who are the top 5 pharma companies in the US The pharmaceutical industry in the US has been in existence since the mid-1800s with the origins of Pfizer, J&J, and Merck & Co. The United…
What is Humira, and what Humira is used for? Humira is a brand name of Adalimumab drug manufactured by AbbVie company in the United States. It is a tumor Necrosis Factor (TNF) blocker that is used to reduce the effectiveness…
The pharmaceutical industry is the most highly regulated industry in the world. Every pharmaceutical manufacturing company has to face various audits by the Drug department and other players. To comply with the requirements of audits companies have to prove that…