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James Francum
By James Francum
on September 03, 2014

ICH Harmonization ProcessThe 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.

James Francum
By James Francum
on August 14, 2014

Ink Color for Signing DocumentsNot 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.

Dr Zuhdi Hussein
By Dr Zuhdi Hussein
on July 15, 2014

Quality By DesignPharmaceutical 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).

James Francum
By James Francum
on June 10, 2014

Process ValidationHow 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

Deviation ManagementYour 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.