Pharmaceutical isolators have revolutionized aseptic manufacturing by offering a controlled, contamination-free environment that enhances both product safety and operator protection.
As the pharmaceutical industry continues to evolve, aseptic processing must keep pace with advancing technologies. The choice between Open RABS, Closed RABS, and Isolators is crucial in ensuring sterility, regulatory compliance, and cost-effectiveness in injectable manufacturing.
The CPCA for Nitrosamine simplifies the complex process of assessing nitrosamine impurities by categorizing them based on carcinogenic risk.
Calculating acceptable intake (AI) limits for nitrosamines in pharmaceuticals is critical to ensuring patient safety. By accurately determining AI limits, we can minimize potential carcinogenic risks and maintain the highest standards of drug safety.
Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization. Such complaints are related to the safety, performance, or effectiveness of medical devices, as per ISO 13485 and FDA . Companies must address complaints promptly and effectively to maintain customer satisfaction and uphold Regulatory compliance.
The FDA’s Bioresearch Monitoring Program (BIMO) is critical for maintaining the integrity of clinical trials. In this blog, we explore the nuances of BIMO inspections and offer detailed guidance for clinical researchers to navigate these complex evaluations.
Periodic reviews are conducted throughout the operational life of computerized system to verify that it remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures. The review should confirm that operational controls are in place and are being effectively applied.
Periodic user access reviews are essential for maintaining the security and integrity of computer systems in the pharmaceutical industry. They play a crucial role in safeguarding sensitive data and ensuring compliance. This blog explores the importance, challenges, and strategies for implementing effective access controls.
Enhance efficiency and compatibility by transitioning from CSV to CSA, ensuring seamless integration across platforms and systems for improved performance and streamlined operations.
21 CFR 211 compliance is your organization’s stepping stone to meeting the FDA’s definition of current good manufacturing practice (cGMP). Complying with 21 CFR 211 proves that your business has a safe, effective, consistent and quality-managed drug manufacturing operation in place.
Unlock the secrets of regulatory compliance comparison of EU Annex11 and 21CFR Part 11! These guidelines differ in scope and requirements, ensuring your computerized systems meet the highest standards in pharmaceutical and life sciences.
Computer Systems Validation (CSV) – is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable.
In the life sciences sector, aligning with 21 CFR Part 11 isn’t just good practice—it’s crucial. This regulation, part of the Code of Federal Regulations, ensures the reliability of electronic records and signatures for FDA-regulated entities like pharmaceuticals, medical device manufacturers, and biotech firms. Let’s simplify what this means and how to stay compliant.
