ISO 13485 design and development

ISO 13485 is the blueprint for quality management in medical devices. Design and development being very critical components of a medical device; ISO 13485 design and development is considered a very important section relating to this aspect of a medical device. Being the extant standard; the ISO 13485 standard has superseded a number of previous […]

ISO 13485 customer property

ISO 13485 2003 is the global standard that concerns itself with quality management for medical devices. ISO 13485 has a section on how businesses should deal with customer property. ISO 13485 customer property is covered in ISO 13485: 2003 Section 7.5.4. The aim of ISO 13485 customer propertyis to ensure that the property a customer […]

ICH Q7 guidelines

What is ICH Q7? The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug. When did it come into effect? The ICH Q7 was arrived at by the International Conference […]

ICH guidelines for API

ICH guidelines for API are guidelines from the ICH specific to the active pharmaceutical ingredient (API) of the drug. A small note about ICH Q7: The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). The scope of this guideline covers all GMP aspects of manufacturing, quality control and trading of […]

ICH guideline Q7

As an ICH guideline, Q7 takes a primary position. ICH guideline Q7 relates to the whole range of Good Manufacturing Practice (GMP) for a human drug’s Active Pharmaceutical Ingredient (API) covering the US, the EU and Japan. Originally called the ICH Q7A; these guidelines were issued in November 2000 by the International Conference on Harmonization […]

FDA guidance on method transfer

FDA guidance on method transfer is a kind of conundrum. On the one hand, there should be no complexity in analytical method transfer because the nature of method transfer is simple. On the other hand; there are no clearly defined guidelines on the subject from the FDA, making it something of a system that is […]

CMDR medical device classification

The Canadian Medical Device Regulations (CMDR) is the guidance that classifies medical devices in Canada. Medical devices are classified according to the level of risk they pose for the user, be it the patient or the people employed in the healthcare industry. The global body that oversees this classification is The Global Harmonization Task Force […]

CMDR classification

The Global Harmonization Task Force (GHTF) is deemed with the task of issuing guidance documents on medical device risk classification. Its classification is made based on the risk level the medical device poses. The US, Canada and the EU are covered in the Task Force’s guidance. The guidance that deals with medical device risk classification […]

BRC risk assessment

BRC, short for British Retail Consortium, is a body that sets global safety standards for food. Its standards are part of a leading safety and quality certification program. With a membership of over 17,000 certified suppliers in more than 90 countries, BRC works through a coordinated network of over 80 accredited or recognized certification bodies. […]

BRC Risk Analysis

BRC risk analysis is about the guidelines issued by the international risk analysis body, the British Retail Consortium (BRC). Being a product of deliberations over a long period of time; BRC is today a global food safety standards body thatis hard onrisk analysis. This makes BRC risk analysisa unique proposition that stands apart from its […]