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 […]

Analytical method transfer

Analytical method transfer is an important element of a laboratory. A laboratory will be required to send or transfer its methods for a variety of reasons to another laboratory. During this process, analytical method transfer comes into play. Analytical method transfer has been described as“…the process of transferring a validated analytical method from a sending […]

Analytical method transfer guidelines from FDA

Theoretically speaking, analytical method transfer guidelines from FDA are quite simple. The logic behind analytical method transfer guidelines from FDA is like this: in its elementary form, analytical method transfer is the way by which a laboratory becomes qualified to use a test procedure. In setting out analytical method transfer guidelines, FDA makes it mandatory and necessary […]

Supplier audit program

Supplier audit program An internal audit program is needed for any business in which continuous work is needed, such as documentations. An audit ensures that the root cause of documentation is addressed. Documentation that is proper and process-oriented is a regulatory requirement, and hence an audit program is a must. A proper audit program that […]

List of DHF requirements

List of DHF requirements Which are the DHF requirements that the FDA looks for? DHF requirements are a very important part of the DHF. The DHF shows conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. It is meant to show that the inputs that were specified […]

GMP requirements from the FDA

GMP requirements from the FDA FDA Good Manufacturing Practices (GMP) is a set of guidelines issued by the FDA for various disciplines. There are GMP requirements FDA has for areas ranging from cosmetics to food to pharmaceuticals to API’s. Why GMP’s? Why are GMP requirements FDA has put in place necessary? It is for the […]

Essentials of foreign materials

Essentials of foreign materials The HACCP program is in place to counter the dangers of foreign material that could get into food and food products. The FDA has very strict regulations that govern food that enters our palate. The United States Department of Agriculture, Food Safety and Inspection Service (FSIS) defines foreign material as “…non […]