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INDUSTRY RESOURCES

14
Sep
Should You Rotate Disinfectants? Industry Experts Weigh In

Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.

Posted in:Manufacturing,Training,
Tags:disinfectants,microbial contamination,microorganisms,sanitizers,
10
Sep
Regulatory GMP Expectations For Learning, Training, & Performance In Pharma/Biopharma

Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.

Posted in:Manufacturing,Training,
Tags:GMP.training,learning,performance,
22
Aug
Brexit: The Good, The Bad, And The Chaos

With just over half a year to go until the divorce date, and roughly two months until European Chief Brexit Negotiator Michael Barnier’s self-imposed October deadline for a Brexit deal, it has started to feel like we are finally seeing some concrete progress when it comes to Brexit.

Posted in:Manufacturing,
Tags:brexit,
20
Aug
Best Practices For Compliance With The New Elemental Impurities Requirements

New requirements for control of elemental impurities went into effect at the beginning of 2018, replacing the longstanding requirements for heavy metals. Elemental impurities guidances are based on modern safety considerations specific to the elements identified.

Posted in:Manufacturing,
Tags:elemental impurities,heavy metals,ICH,laser,
16
Aug
4 Pitfalls To Avoid When Developing GCP SOPs

This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.

Posted in:Clinical,
Tags:data integrity,GCP,GMP,ICH E6,quality,SOPs,
15
Aug
How To (Better) Identify And Analyze Manufacturing Trends In Your GxP Organization

This is the first in a five-part article series, Identifying And Resolving Errors, Defects, And Problems Within Your Organization. This article will enhance your understanding and prime you for visual detection of real trends in your organization by looking at a couple of examples. (You will understand the relationship between this picture and your quest for the quantitative truth by the end of this article.)

Posted in:Manufacturing,
Tags:CAPA,GXP,QA,trend,

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