Is your organization a part of the food chain?

The exploding and irreversible pace of globalization has brought in its wake changes in almost all areas of human activity. Goods and commodities that were once confined to one’s local area have now started reaching out to the unlikeliest corners of the world. One of the most active and important of such items to undergo […]

Investigations in Pharmaceutical Water Systems

nvestigations in pharmaceutical water systems are very critical for pharmaceutical organizations and laboratories. They can mean the difference between compliance and noncompliance. In many cases, organizations can get hauled up by regulatory authorities for failing to carry out proper investigations into pharmaceutical water systems. The most common problem encountered by pharmaceutical and biotech companies and […]

ISO 9001’s Process Approach to Quality Management

ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place. It is all about process Where this approach differs from the previous standard is that it improves upon it by […]

Medicaid Vs. Medicaid EHR Incentives

Medicaid vs. Medicaid EHR Incentives & Meaningful Use Certifications in US The aim of Electronic Health Records (EHR) is, as we all know, to digitize the entire database of medical records of all patients across the US. One of the offshoots of the technological revolution; EHR is a brilliant step towards ensuring that medical records […]

ISO 14001, the world’s most Popular Standard for Environmental Management

If one were to be asked at a quiz which the most popular standard for environmental management is; the answer shouldn’t be difficult to give: it is the ISO 14001 by a long shot. In fact, since its enactment in 1996, ISO 14001 has been so popular that many think it is the only existing […]

Excel Spreadsheet Validation for FDA 21 CFR Part 11

Given the ease of their operations; spreadsheets find wide acceptance in a number of activities for laboratories. These include analysis, data capturing and reporting. Since these activities are part of a regulatory framework; companies using these spreadsheets need to comply with guidelines. These guidelines are set out in FDA 21 CFR Part 11, which deals […]

Quality guidelines –ICH

Quality guidelines –ICH. Short for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; the ICH is a collaborative project whose objective is to discuss scientific and technical aspects of pharmaceutical product registration. The regulatory authorities of Europe, Japan and the United States, as well as experts from the pharmaceutical […]

FDA Guideline on Process Validation

FDA Guideline on Process Validation. Process Validation (PV), as defined by the FDA, has undergone a change from the past 25 years or so. The meaning of PV is what the FDA assigns to it. So, any understanding of PV has to be tied to FDA’s guidelines which offer a definition of the term, as […]

Good Practices on 510(K) Preparation and Clearance

Good Practices on 510(K) Preparation and Clearance. First, a basic understanding of the 510 (K): A 510(k) is essentially a premarket submission that the medical device manufacturer makes to FDA to show that the device that the manufacturer intends to market is at least as safe and effective, or to use FDA parlance, Substantially Equivalent […]

GxP in Computer System Validation

GxP in Computer System Validation. GxP (Good X Practice, where according to FDA compliance; X can mean Clinical, Laboratory, Manufacturing, Pharmaceutical, etc., and used according to the situation in which they occur) in Computer System Validation occupies a position of primacy in the field of technology because of various reasons. The important ones among these […]