Introduction: In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct. Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This Article sheds light on Zenovel’s recent involvement in the monitoring of three studies of Indacaterol/Glycopyrronium conducted… Continue reading Mastering Inhalation Studies: A Closer Look at Challenges and Solutions
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FAQ GxP Quality Guidelines
GxP Quality Guidelines and Regulations: Frequently Asked Questions: What happens when GxP regulations are not followed? Noncompliance with GxP regulations can result in significant repercussions for sponsors and their collaborators. This could include financial penalties and legal actions. If a sponsor fails to adhere to federal GxP regulations to a significant extent, endangering public safety,… Continue reading FAQ GxP Quality Guidelines
GMP Audits Unveiled: Behind the Scenes of Ensuring Compliance
Understanding the role of GMP Audits and Its Importance Good Manufacturing Practices (GMP) are a set of guidelines and regulations that ensure products are consistently produced and controlled according to quality standards. GMP audits are comprehensive assessments conducted to verify whether manufacturers are complying with these established practices. They encompass various aspects such as facility… Continue reading GMP Audits Unveiled: Behind the Scenes of Ensuring Compliance
How to Prepare Subject Matter Experts for FDA Inspections
Introduction Facing an FDA inspection can be a nerve-wracking experience for any pharmaceutical company. While many focus on logistics and documentation, one crucial aspect that should not be overlooked is preparing your Subject Matter Experts (SMEs) for the inspection. SMEs, who possess in-depth knowledge of your front-line operations, can unintentionally provide information that may harm… Continue reading How to Prepare Subject Matter Experts for FDA Inspections