On December 12, during a speech at the Food and Drug Law Institute (FDLI) Enforcement, Litigation, and Compliance Conference, FDA Commissioner Scott Gottlieb M.D. announced the formation of the FDA Dietary Supplement Working Group.  Dr. Gottlieb indicated the Working Group was created “to take a hard look at what more the FDA can be doing

In December 2018, the FDA released a Draft Guidance entitled, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” According to the document, the FDA intends to promulgate new regulations pertaining to compounding pharmacies that register as “outsourcing facilities” under Section 503B of the FD&C Act. Since

Time and time again when working with a client to isolate the source of contamination in their products or manufacturing facility, we ultimately determine that water is the source of the problem.  Although it may seem like a benign agent in the manufacturing and cleaning process, our experience has shown that water is frequently the

In September, the SIDITM Workgroup released an updated version (Version 3.0) of the Standardized Information on Dietary Ingredients (SIDITM) Protocol. A group comprised of the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA), and their member companies produced this most recent version. CRN, CHPA, the

The United States Pharmacopeia (USP) has proposed a new chapter to address one of the most prevalent microbiological threats in the pharmaceutical and healthcare industries. USP proposed Chapter <60> “Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex,” provides, for the first-time, compendial methods for detecting these troublesome microorganisms. B. cepacia Complex (BCC) is a

As the one-year anniversary of the implementation of new elemental impurities requirements for brand and generic drug products approaches on January 1, the FDA has released a Guidance Document entitled, “Elemental Impurities in Drug Products: Guidance for Industry.” The Guidance Document, issued on August 1st, provides recommendations for: How applicants submitting new drug applications (NDAs)

The leaves have fallen, baseball season has transitioned into football season, and students are settled in back at school, all sure signs that Autumn has arrived. Here at Q Laboratories, we consider every season back-to-school season because we recognize the need always to continue learning. Whether it is re-training on the performance of a method or

The FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality’s (OPQ) 2017 Annual Report provides a panoramic snapshot of the Pharmaceutical Industry and the regulatory and quality activities therein. Established in 2015, the OPQ consists of over 1,300 staff responsible for regulating the quality of human drugs marketed in the US, providing

Microorganisms present in pharmaceutical products or ingredients not only pose a threat to the user but may also reduce or inactivate the therapeutic function of the product. To address this threat, USP Chapter <1111> – Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use, provides two tables of microbiological

In April, the FDA released a Guidance Document, entitled, “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs) – Questions and Answers – Guidance for Industry.” The document is intended to “provide guidance regarding good manufacturing practice (GMP) for the manufacturing of APIs under an appropriate system for managing quality…and help ensure that APIs