iSpeak Blog

Read, Learn, Innovate: Top Blog Posts from Febuary 2020

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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.


What's Next for Aseptic Processing in Pharma?

What's Next for Aseptic Processing in Pharma?​​​​​​​

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. 

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GAMP® Pragmatic Quality & Risk-Based Approaches: Part 2 Infrastructure - Embrace Automation​​​​​​​

GAMP® Pragmatic Quality & Risk-Based Approaches: Part 2 Infrastructure - Embrace Automation

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.

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Coronavirus Pandemic: Is Your Supply Chain Continuity Plan Ready?​​​​​​​

Coronavirus Pandemic: Is Your Supply Chain Continuity Plan Ready?

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.

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GAMP® Support for Pragmatic Quality & Risk-Based Approaches

GAMP® Support for Pragmatic Quality & Risk-Based Approaches

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.

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How GMPs & Data Integrity Align for Safer Products & Swifter Approvals​​​​​​​

How GMPs & Data Integrity Align for Safer Products & Swifter Approvals

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).

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