Harmonization Processes Through ICH  

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.

What Color Pen Can I Use to Sign Documents?

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.

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process

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).

Clarifying the Difference in Equipment Qualification and Process Validation

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.

Meeting Compliance Goals With Deviation Management And CAPA Systems

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.

Instituting Effective FDA Gap Analysis Policies

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.

IT Infrastructure Qualification: Keeping GxP Firms Tech-Compliant

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.

FDA Demands Full Compliance With GMP Requirements in the Pharmaceutical Industry – To What Extent Is Compliance Required?

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.

The European Medical Device Directive As It Compares To 21 CFR 820

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.