In the minds of many pharmacists, current good manufacturing practices (CGMP) have unduly raised the bar of compliance under the jurisdiction and authority of state boards of pharmacies (SBOP).

But compared to the potential financial and safety-related consequences of noncompliance, properly implemented CGMP should not be seen as a regulatory burden, but a reliable safeguard against potentially disastrous outcomes—a point made clear in 2012 when improper compounding at the New England Compounding Pharmacy sparked an outbreak of fungal meningitis which resulted in 64 deaths, 751 injuries, and 25 counts of second-degree murder.

Continue Reading

Earlier this month, FDA released a new draft guidance offering details on what constitutes an "incomplete" new drug application (NDA) or biologics license application (BLA), and when these issues can lead to a "refuse to file" decision.

As a brief primer, FDA's refuse-to-file action quickly informs sponsors of a problem in an NDA or BLA so they can correct issues and avoid waiting for a complete response letter from the agency.

An incomplete application subject to refusal can also be one for which minor components have not been received within 30 calendar days after receipt of the original application.

Continue Reading

To assess the applicability and necessity of CGMP to drug compounding, several definitions provided in section 210.3 Definitions of the FD&C law must be mentioned:

• Drug manufacturing is defined as the “manufacture, processing, packing, or holding of a drug product [that] includes packaging and labeling operations, testing, and quality control of drug products.” The diagram below illustrates the necessary steps required to manufacture several different forms of drug products and a device.

A drug product “means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients.” The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.

Continue Reading

Watch a snippet of our free webinar, The Importance of CGMP to the Safety of Compounded Drugs, and hear presenter Gary E. Ritchie offer a summary of compliance requirements for 503B outsourcing facilities as well as an overview of the most critical compliance items related to CGMP and a QMS.

Continue Reading

The increasing complexity of clinical trials and the emergence of new technologies for gathering clinical data have heightened the need to enhance and sustain data integrity throughout all phases of clinical studies.

In recent years, the number of current good manufacturing practice (CGMP) violations related to data integrity has risen significantly. Approximately 80 percent of all warning letters cited data integrity in 2016 versus just 25 percent in 2013.

This stark difference points to a serious problem: More and more drug developers are maintaining quality systems that are not adequately ensuring the safety and accuracy of electronic data and records.

Continue Reading

Earlier this month, FDA released its Unified Agenda with proposed and final rule-makings on the docket for 2018. These include new rules on drug compounding, foreign clinical data and new ways to market nonprescription drugs.

We've summarized FDA's 2018 agenda items into a quick-read guide below.

Continue Reading