A very brief overview of Post marketing Safety Management

Post marketing Safety Management is a very important area of a Good Clinical Practice (GCP) and Good Vigilance Practice (GVP). This is why the FDA has very detailed and clearly laid out requirements that organizations and sponsors of clinical research have to comply with as part of meeting safety requirements. The FDA’s requirements on post […]

Validation of Pharmaceutical Water Systems

Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals. A very important reason for which validation of pharmaceutical water […]

Understanding the Pharmaceutical Batch Record Review

The pharmaceutical batch record review is a very crucial tool for ensuring both quality of the product process and compliance with regulatory requirements. It is an important means by which pharmaceutical organizations can formulate two important strategies: A pharmaceutical batch record review is a very effective medium for keeping complete track of the firm’s day-to-day […]

Orphan Drugs in the USA

Orphan drugs are drugs that are exclusively developed and used for treating rare diseases. Orphan drugs are not researched and developed for widespread use, since by their nature, they are meant only for rare diseases. Since by definition, a rare disease is not likely to have too many patients; orphan drugs are limited in their […]

Orphan Drugs in the European Union

Rules concerning orphan drugs in the European Union are largely inspired by those concerning orphan drugs in the US. Orphan drugs in the European Union are based on and built on the same premise, namely offering support to pharmaceutical companies that manufacture drugs to treat rare diseases. Regulations on orphan drugs in the European Union […]

Rule relating to orphan drugs in Japan

Orphan drugs are those that are developed purely to treat rare diseases. The nature of orphan drugs is a little piquant: on the one hand, rare diseases affect very few people, but these cannot be ignored. On the other hand, orphan drugs, since they are so few in number, are not taken up usually by […]

Tips for managing CRO’s

The role of clinical contract research organizations (CRO’s) has come into focus of late, with the burgeoning growth of the outsourced model for business. In the clinical research industry, CRO’s are considered viable alternatives to expensive domestic players. This is because since it is the clinical study process that needs to be outsourced to developing […]

Laboratory Safety Management should be thorough and comprehensive

Laboratory safety management is about being alert and on one’s toes all the time and every time. This is easier said than done, because laboratories, being the location at which various tests and experiments take place, are a source of many dangers and contaminants. Laboratory safety management is imbibed in Good Laboratory Practices (GLP). In […]

Japanese Institutions and Regulatory Authorities

Japanese institutions and regulatory authorities are organized in a rather complex way, with a few institutions and regulatory authorities being responsible for the oversight of regulating pharmaceuticals, and a few others, purely for developing pharmaceuticals. The overall regulator of the Japanese institutions and regulatory authorities is the Japanese Ministry of Health, Labor, and Welfare (MHLW), […]

The ISO 9001:2015 – the latest revision to the ISO

The ISO 9001:2015 is the latest revision to the set of ISO standards, and is considered a major update to the existing standard. The ISO consists of a set of standards, implementing which an organization can bring about improvements into the auditing of its Quality Management Systems. First, an understanding of Quality Management System A […]