Developing Documents and Records to meet the Requirement of ISO 17025

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard. A highly meaningful […]

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 […]

The impact of effective complaint handling on quality system

Effective complaint handling makes an extremely important impact on the quality system. An effective complaint handling is at the core of a quality system. If a product enters the market having got FDA approval and still receives complaints, it means that the device needs to be worked on and the complaint redressed. Effective complaint handling […]

CAPA risk assessment

Corrective and Preventive Action (CAPA) is an integral part of a medical device organization’s Quality System. CAPA is one of the dreaded terms for a quality professional; yet, very few realize that putting a CAPA in place for each and every event is a liability. Rather, putting a CAPA for critical activities of the medical […]

API Process Inspection –what does the FDA expect?

    API Process Inspection –what does the FDA expect? Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to. The FDA and API Process Inspection Rules regarding what the FDA expects are […]