Pharmaceuticals
The Value of Role-Based Alarm Templates
Best Practices for Closing Coverage Gaps and the Role-Based Alarm Advantage Imagine it’s 2 a.m. on a holiday weekend, and a freezer excursion begins. In this moment, the challenge isn’t just detecting the issue, but ensuring the right person is notified. Is it going to a lab manager who is off site, potentially delaying the…
Read MoreModern Mapping and Validation Webinar Recap
Did you miss our recent “Audit Ready in Any Season: Modern Mapping & Validation” webinar, or want to revisit the highlights? We’ve got you covered. In this session, Dickson experts Mark Friske (Mapping Solutions Manager) and Antoine Nguyen (VP of GxP & Compliance), along with host Evan Smith, guided attendees through the fundamentals of thermal…
Read More6 Must-Have Environmental Monitoring Features for Pharma Manufacturers
For pharmaceutical manufacturers, you know environmental monitoring systems are a key part of any quality management system, essential for pharmaceutical storage control, and serve as your first line of defense in an audit. While many systems can log data, only a select few are truly built to help you navigate the complex challenges of a…
Read MorePharmaceutical Cold Storage & WHO Annex 9
Pharmaceutical Cold Storage and WHO Annex 9 Compliance: What You Need to Know Pharmaceutical products, such as vaccines, biologics, and insulin, require strict environmental conditions to remain effective. Proper pharmaceutical cold storage is essential to maintaining the integrity, efficacy, and safety of these temperature-sensitive medicines. There are financial impacts at stake, including product loss. However,…
Read MoreOvercoming 5 Contract Pharmaceutical Temperature Challenges
Maintaining consistent and reliable environmental conditions isn’t just best practices for your business — it’s a cornerstone of contract manufacturing that’s built into the very structure of pharmaceutical regulations and your customers’ expectations. Yet, navigating this intricate web of demands can feel like traversing an increasingly complex landscape. Consider this: temperature control failures alone cost…
Read MoreTemperature Mapping: A Critical Process for Maintaining Compliance
In regulated industries, we often encounter materials and processes that are highly sensitive to temperature and humidity. The storage of certain pharmaceuticals is one example. In these situations, temperature mapping, also referred to as thermal mapping, is a GxP method that is used to prevent the impact of temperature or humidity fluctuations to product quality.…
Read MoreYour Guide to Pharmaceutical Validation & 6 Principles for Effective Implementation
In good manufacturing practice (GMP) and other GxP’s, the term validation has a formal, specific meaning. In this context, validation is a quality management tool used to confirm that a process or a piece of equipment satisfies its intended purpose through the use of objective data. In highly regulated industries like pharmaceuticals, validation is used…
Read MoreWhy Is Temperature Mapping in Pharma Important?
A growing trend in the pharmaceutical industry is the development of more complex and fragile products, like biologicals, chemical mixtures, and large molecules (COVID-19 vaccines are an example of this trend). These products generally must follow a standard operating procedure (SOP) that requires more stringent temperature controls to prevent them from degrading or deactivating during…
Read MoreUnderstanding Pharmacy Temperature Requirements for Medication Storage
If vaccine and pharmacy medication storage reaches the wrong temperature, several things can happen – rendering them less effective than intended or even chemically altered, causing inadvertent patient harm. Because of this risk, strict pharmacy temperature requirements have been put into place to ensure medications are manufactured, transported, and stored properly before they reach the…
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