The Device History Record (DHR)

The Device History Record (DHR) The US FDA states the following: Each manufacturer should maintain DHR’s. For what steps in the manufacturing process are these records to be maintained? It is for establishing and maintaining procedures to ensure that DHR’s for each batch, lot, or unit. The purpose of this requirement is to show that […]

QBD Analytical Method

QBD Analytical Method ICH Q8 (R2) describes the nature of Quality by Design (QBD). QBD is a systematic approach to pharmaceutical manufacturing and development. Based on exact science with incontrovertible evidence, QBD aims at bringing about product and process understanding and process control. QBD seeks to bring all these about by beginning with predefined objectives. […]

OHSAS 18001 Gap Analysis Audit

OHSAS 18001 Gap Analysis Audit OSHA stands for Occupational Safety and Health Administration. OSHA 18001 is the international standard that ensures safety and health at the workplace. It is the organization that has to show compliance with the provisions set out in this standard by ensuring that it is implementing OSHA 18001 at its workplace. […]

ISO 13485 vs. ISO 9001

ISO 13485 vs. ISO 9001 One of the most commonly countered questions in the medical device industry is: ISO 13485 vs. ISO 9001. They are often confused for each other. But they are never the same, although they have many common requirements. ISO 13485 is part of ISO 9001 family of regulations When understanding ISO […]

ISO 13485 internal audit

ISO 13485 internal audit So, you are in the medical devices industry, and one of the first items you would come across in your profession is having to deal with an ISO 13485 audit. What is the ISO 13485, and what does it take to audit it? Understanding the ISO 13485 First things first. Let […]

ISO 13485 Gap Analysis

ISO 13485 Gap Analysis Gap analysis is an important aspect of the ISO 13485 audit. The ISO 13485 standard lists out requirements for a wide-ranging management system for the manufacture and design of medical devices. When a medical device organization performs a gap analysis, it is analyzing the gaps that exist in its QMS vis-à-vis […]

The Device Master Record (DMR)

The Device Master Record (DMR) The Device Master Record (DMR) is what may be described as the complete documentation required in the manufacture of medical devices that meet quality standards. The DMR, along with the Device History Record (DHR), is an extremely important element of the Quality System Regulation (QSR) in relation to FDA cGMP. […]

USP 1225

USP 1225 Quality levels of pharmaceutical items are set out in various test procedures and instruments. US pharmacopeia, which deals with specifications of drugs and other pharmaceutical products, uses the following criteria to assess the method validation of these products: accuracy precision specificity detection limit quantitation limit linearity range robustness Types of test methods USP […]

ISO 14001 –the management’s responsibilities

ISO 14001 –the management’s responsibilities ISO 14001 deals with an organization’s environmental policy.  This instrument has been designed to ensure that organizations achieve and demonstrate sound environmental performance. An organization has to assess the impact of its business on the environment and shape its environmental policy accordingly, so that it contributes to sustainable development. Management’s […]

Aspects to look out for in your ISO 13485 Quality Manual

Aspects to look out for in your ISO 13485 Quality Manual Each and every organization that implements ISO 13485, an important ISO standard, has to have a Quality Manualin place. The ISO 13485 sets out requirements for a complete management system for organizations that are in the business of designing and manufacturing of medical devices. […]