Read, Learn, Innovate: Top Blog Posts from Decemeber 2019
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
A Road Map for the Implementation of Single-Use Technology
The growth of single-use technology has revolutionized the bioprocess industry. The implementation of single-use technology has typically been a trial and error exercise for the end users. The main objective of the ISPE Good Practice Guide: Single-Use Technology is to provide the ability to plan, anticipate, and respond to surprises that can arise when implementing this new technology.
Common Pitfalls During Implementation of a Cleaning Validation Program
Discover the most common violations to avoid for the implementation of a cleaning validation program in today’s industry with product-specific operations, sterile manufacturing, and how to organize pre-approved strategies. In addition, solutions to these common pitfalls are featured in this article.
Falsified Medicines Directive – Implementation in Clinical Supply Chains
Falsified Medicines Directive 2011/62/EU was published by the European Parliament on 08-Jun-2011. The Directive was implemented to increase the security of the manufacturing and delivery of medicines across Europe, protect patients and prevent falsified medicines from entering the supply chain.
A New Beginning: Launch of the ISPE Mexico Affiliate
The formal announcement and certification of the ISPE Mexico Affiliate took place at the recent 2019 ISPE Annual Meeting & Expo in Las Vegas, Nevada. The creation of the ISPE Mexico Affiliate was promoted by a group of enthusiastic expert industry professionals from various companies considered as benchmarks in the pharmaceutical and biopharmaceutical industry sectors in Mexico.
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.
