Featured in this edition of iSpeak Reading Roundup, are the top blog posts from February 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key production questions, like how to keep the process sterile and compliant with the law and the regulatory guidelines. All this is influenced by new methods and technology innovations, either process- or technology-based.
This Blog focuses on the topic of infrastructure, covering recommendations made by an FDA / industry team linked to the FDA Case for Quality initiative, and the GAMP re-examination of approaches to infrastructure.
Today we are facing a new type of challenge with an undefined period of impact. Many of your companies have already started to engage your BCP and are finding gaps due to the unique level of impact that the virus imposes. As an Industry we are all impacted, and it is a prime time to collaborate and help one another to face this challenge. As such we welcome you to participate in this blog to discuss how you have been working to prepare for this threat.
The GAMP® Global Leadership strongly supports a patient-centric and quality risk-based approach to the assurance of computerized systems. Explore the incorporation of innovative computerized technologies and approaches that advance pharmaceutical production to support product quality, patient safety, and data integrity.
FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR part 210 (the Manufacturing, Processing, Packing, or Holding of Drugs), 21 CFR part 211 (for Finished Pharmaceuticals), and 21 CFR part 212 (for Positron Emission Tomography (PET) Drugs).
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...