EMR and Automation: FDA Compliance Leaders

By |October 15th, 2015|

In order to join the FDA compliance leaders in the pharmaceutical industry, your business must incorporate electronic medical records and automation for day-to-day processes that invite human error. Companies like Eli Lilly, Gilead Sciences and Johnson & Johnson embrace new automation and EMR technologies.
The right medical CRM software package eliminates human error from medical record-keeping and […]

Learn How to Deal With Mold Problems in the Pharmaceutical Industry

By |October 5th, 2015|

Mold is an ever-present part of the natural environment but it is an unwelcome guest in pharmaceutical manufacturing facilities that must remain sterile in order to maintain the quality of the products that they produce. Detection of a mold infection can lead to a product recall, and possibly a facility shutdown until the problem is […]

FDA Compliance Issues: Form 483 Warning Letters

By |September 28th, 2015|

Has your business ever received the dreaded FDA Form 483 or an associated warning letter?  If not, you can count your enterprise among the lucky ones, who are actually perceived to be in full FDA compliance. If so, you may already know that you must take action.  According to, FDA warnings have become increasingly prevalent […]

The Challenge of How to Meet Serialization Requirements in the Pharmaceutical Industry

By |September 18th, 2015|

How to meet serialization requirements is an ongoing challenge in the pharmaceutical industry. The lack of understanding and numerous kinks in the system relating to federal compliance has a tremendous impact on global operations and the supply chain. U.S. regulations involve not only company preparation but connecting to and coordinating with diverse supply network of CMOs/CPOs, […]

Media Fill Guidelines for the Pharmaceutical Industry

By |August 31st, 2015|

Contamination is a major concern in the pharmaceutical industry. The Food and Drug Administration requires strict compliance regarding this issue and in some instances the shutting down of pharmaceutical production operation takes place until the manufacturer locates the source of contamination, rectifying and addressing issues. Here are some guidelines for what the FDA looks for […]

Coming Land Use Rules Call for Medical Marijuana Consulting Firm with Expertise in MMPR Licenses

By |August 28th, 2015|

Canada’s passage of new laws governing the production of medicinal marijuana have opened the doors to a new industry ready and willing to provide supply for the growing demand for the product. But passage of the new Marijuana for Medical Purposes Regulations, or MMPR, did not clearly outline all the ways for companies to begin marijuana production. […]

New FDA Serialization Requirements Aim to Fight Rising Tide of Fake Drugs in the Pharma Industry

By |August 25th, 2015|

The Food and Drug Administration is trying to improve the safety of the pharmaceutical supply chain and it is doing so through changes that improve the way that products can be identified and tracked at each link in the chain. Distributors, drugs packagers, and pharmacies must all raise their standards for tracing the products that […]

Data Integrity, What can be done?

By |August 20th, 2015|

By definition, data integrity is the “generation, transformation, maintenance and assurance of the accuracy, completeness and consistency of data over its entire life cycle to be in compliance with applicable regulations.”

It is important to understand the fact that data integrity has a wide spectrum of applications therefore, this article will be limited to requirements of […]

How Pharma Regulatory Affairs Experts Can Help Manufacturers With the FDA Quality Metrics Initiative

By |August 17th, 2015|

Drug shortages have become a regular problem in the pharmaceutical industry, leaving hospitals scrambling for alternatives to some commonly used products. The Food and Drug Administration is taking steps to head off some of these shortages at the source: the pharmaceutical manufacturer. As the FDA considers changes in how it evaluates drug manufacturing facilities, it’s […]

Why Understanding How to Execute Commissioning and Qualification Matters to Pharma Manufacturers

By |August 11th, 2015|

Pharmaceutical manufacturers must run through a number processes and procedures to ensure that their equipment meets the proper standards for drug production. Having incomplete procedures can result in missteps that compromise sterility or quality, running the risk of failing a regulatory inspection. That’s why it’s important to have thorough procedures outlining how to execute commissioning and […]