Corrective and preventive actions, or CAPAs, play a vital role in how GxP firms maintain compliance with FDA standards. A corrective action (CA) is an action to eliminate the cause of a detected nonconformity, or any other situation deemed to have adverse effects on a drug product. A preventive action (PA) is an action to eliminate the [...] Read More
It’s hard to navigate in the dark, and although FDA regulations can seem blindingly overwhelming, smart pharmaceutical manufacturers actually use them to clarify [...] Read More
Quality risk management implementation identifies and manages risks; under normal circumstances the risk-based approach to the validation of computerized systems should eliminate the risks to the system, or should at least reduce the risks to a tolerable level. (This tolerable level must naturally be [...] Read More
Electronic record keeping is an essential yet complex part of running a life sciences firm. Modern software tools afford medical device manufacturers numerous methods for digitally tracking lots, batches and supply chain [...] Read More
- Reducing the likelihood that unsafe, ineffective, and poor quality drugs will enter the supply chain and reach consumers.
- Raising public awareness of drug security threats and vulnerabilities in the supply chain.
These goals stem from the Drug Supply Chain Security Act (DSCSA) Title II of the Drug Quality and Security Act of 2013 in which the following [...] Read More
The FDA’s Quality System Regulation shouldn’t act as a hindrance to medical device manufacturers. While many companies are wary of falling afoul of the compliance guidelines contained in Title 21 CFR sections like Part 820, smart leaders realize that FDA QSR compliance can be a stepping [...] Read More
GxP-CC has achieved ISO 9001:2008 certification. Developed by the International Organization for Standardization, ISO 9001:2008 is recognized as the worldwide standard for [...] Read More
Your firm’s pharmaceutical products aren’t the only things subject to U.S. and international regulations. For decades, agencies like the FDA have also required manufacturers to adhere to a range of best practices that include management of production facilities and supply chains.
The Current Good Manufacturing Practices, or cGMPs, include a number of regulations and recommendations designed to help firms protect public safety. Learning which of these guidelines apply to [...] Read More