Why is foreign material control important?

Why is foreign material control important? Foreign material control is critical for the US food industry. American consumers are very wary when it comes to food contamination, given their predisposition to diseases such as cancer. US authorities try to contain contamination in consumers’ food for a number of reasons.Foreign material control is important because: –        […]

Why is a supplier audit program necessary?

Why is a supplier audit program necessary? A supplier audit program is a must-have in medical devices and pharmaceutical manufacturers, especially those that outsource their processes. Being such an important element in the supply chain; a supplier audit program is the driving force towards ensuring quality and consistency in the supply chain, and is a […]

What are Design History File Requirements?

What are Design History File Requirements? The Design History File (DHF) is a critical document for a medical device. The DHF is a record of a series of documents that explain the design history of a medical device. In other words, it is a documentation of the way by which the inputs that went into […]

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 […]

QBD in Analytical Method Development

QBD in Analytical Method Development QBD stands for Quality by Design. ICH Q8 (R), Step 2 defines QBD as “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. QBD in analytical method development is an important component, […]

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 […]

ISO 14001 internal audit

ISO 14001 internal audit ISO 14001 is an Environmental Management System (EMS) that relates to the external environment in an organization. This regulation lays out standards and rules for implementation of external components of an organization relating to the environment. Based on Deming’s management cycle and modeled after the British standard BS 7750; ISO 14001 […]

GMP’s in foreign material control

GMP’s in foreign material control Since foreign material control is a matter of grave importance to the American public, there are several Good Manufacturing Processes (GMP’s) that are in place for this industry. As defined by the FDA; GMP’s for foreign material control include facility, processing and employee practices aimed primarily at microbial control, but […]

Foreign material detection systems

Foreign material detection systems Putting a foreign material detection system in place is very important. Consider this: in investigations conducted over a period of about a quarter century; the FDA Health Hazard Evaluation Board found out that less than three per cent of objects of the size of over six mm were said to present […]

Foreign Material Control – A basic understanding

Foreign Material Control – A basic understanding Foreign Material (FM) Control is often a source of major problem for the food industry in the US, as a good part of consumer complaints across the food industry in the country relates to FM inclusion in finished food products. This issue has been one of considerable debate […]