The ISO 13485:2016 standard is new and needs to be looked at afresh

With the ISO making the final version of the ISO 13485:2016 standard available; it is now up to companies to start planning ways of implementing it. The major area in which it differs from the earlier version (of 2003) is in the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although […]

Sanitary transportation of human and animal foods needs to comply with new FDA FSMA rules

That the issue of sanitary transportation of human and animal foods is accorded a high degree of importance by the FDA is evident by the fact that the FDA is bound by the US Congress-legislated Food Safety Modernization Act (FSMA) rules, which relate to this subject. At its core, the FSMA seeks to mandate the […]

Ensuring Drug Supply Chain Integrity is a critical task

Drug supply chain integrity is a means to ensuring that the drug that is consumed by the patient has come through proper sources and is free of adulteration, and reaches the right hands. The drug supply chain a complex, yet trackable chain that starts from the time the substances and raw materials are identified for […]

Drug safety and pharmacovigilance are two faces of a coin

If one were to describe the relationship between drug safety and pharmacovigilance; the most concise way of describing it is by calling them as two sides of the same coin. The aspects of drug safety and pharmacovigilance are intricately and inseparably bound together. The whole purpose of pharmacovigilance is the assurance of drug safety. It […]

Activities involved in Computer Systems Validation

Computer Systems Validation (CSV) is central to the life sciences industry. Apart from being a regulatory requirement as set out by various regulatory authorities and practices such as the FDA, EMA, GCP, GLP, GMP and all the Predicate Rules; CSV is also very important to implement because not doing so will result in costly consequences. […]

FDA Requirements for ensuring Premarketing Clinical Trial Safety

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks […]

Preclinical Toxicology & Safety and its core elements

Preclinical toxicology and safety occupies a position of eminence in a clinical research program. A study of preclinical toxicology and safety is absolutely important because this leads researchers to an understanding of what causes adverse effects. Adverse effects form the backbone of preclinical toxicology and safety, because they can come from any source of toxicology. […]

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 […]

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 […]