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.
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.
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 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.
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.
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.
Each year many people start off with how they are going to be better than the year before and write down unrealistic goals about their professional and personal time next the 365 days.
Our team at Women in Pharma® has sat down and put together a...
Since April 2017, the European Pharmacopeia allows to produce Water for Injection (WFI) using other methods than distillation. Meanwhile, the additional water quality "Highly Purified Water" (HPW) could be found in the Ph. Eur. but will be removed in...
Featured in this edition of iSpeak Reading Roundup are the top 10 blog posts from iSpeak in 2019. Gain key insights on FDA process validation guidelines, Pharma 4.0 developments, and more on what the pharmaceutical industry has explored and accomplished...