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By James Francum
on September 03, 2014

The methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively common chemical or physical manufacturing procedures, for instance, you still have to make modifications that fit your specific product design standards.

By James Francum
on August 14, 2014

Not sure which pen to use? Although it seems like an amusing topic, your choice of writing utensil actually does make a difference when you're dealing with FDA documentation.

By Zuhdi Hussein
on July 15, 2014

Pharmaceutical firms that wish to create product lines and cater to consumers as reliably as possible must ensure that their products are of a consistently high enough quality to fulfill user needs. While certain post-production checks and assurances can aid in this area, many organizations find it far more helpful to institute quality by design standards (QbD).

By James Francum
on June 10, 2014

How do you know your life sciences firm is maintaining compliance? While FDA audits and warning letters are obvious indicators, GMP guidelines give you a number of less-stressful ways to determine how well your equipment and processes are performing their tasks and whether they'll continue to do so consistently.

By Henry Macartney
on June 02, 2014

Your firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

By Zuhdi Hussein
on April 25, 2014

When GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it's critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could result in a regulatory authority taking action against your company.

By Zuhdi Hussein
on March 26, 2014

Medical device manufacturers and pharmaceutical companies use advanced IT tools to maintain sensitive business information, manufacture products and establish valid Quality Systems. In the past data integrity has been an important topic and is an increasingly important focus for FDA and EU regulators. The architectures employed by life sciences firms must be designed to facilitate consistent oversight and well-maintained compliance.

By James Francum
on March 12, 2014

The most succinct answer to the question of what determines FDA compliance with GMP regulations of pharmaceutical production is adherence to 21 CFR Part 210 and 211. Anything less than complete adherence will render products as “adulterated” in the eyes of the FDA. Failure to comply could lead to disruptive regulatory action against a company.

By James Francum
on March 10, 2014

The European Medical Device Directive or 93/42/EEC regulates which medical devices may be sold in the European market, while 21 CFR 820 is an FDA Quality Systems Regulation is a document that helps manufacturers of medical devices establish and follow a quality system within their company / organization in order to ensure that their manufacturing processes and the resultant products consistently meet and fulfill their applicable requirements and specifications. The 21 CFR 820 (also known as the FDA’s Quality System Regulation (QSR)) determines the cGMP requirements for medical devices.