Understanding the importance and benefits of auditing Quality Management Systems

Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet customer requirements – are updated and kept […]

Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). There are three types of Premarket Notification 510(K)’s that may be submitted […]

Finessing the ways of using lineament analysis in geological exploration

Geological exploration has many benefits for mankind. Yet, there are a few limitations with the current set of methods being used by geologists. The full extent of technologies is yet to be harnessed. The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process if the […]

Six Systems Approach to Pharmaceutical cGMP Regulations

Six Systems Approach to Pharmaceutical cGMP Regulations. The FDA has enacted several pharmaceutical cGMP regulations. These are key concepts that are critical to quality systems. Some of the concepts by which the FDA and other regulatory bodies ensure cGMP regulations are Quality, Quality by Design (QbD) and product development, Quality Risk Management, Corrective and Preventive […]

Quality by Design (QBD) and analytical methods

Quality by Design (QBD) and analytical methods have come into focus because of an inherent limitation in the guideline used for validation of analytical methods. The International Conference on Harmonization (ICH)’s Q2 guideline, Validation of Analytical Procedures: Text and Methodology serves as the guiding document for validation of analytical methods for pharmaceutical products. Since the […]