The stated mandate of the regulatory authorities (such as the FDA) and pharmacopeias (such as USP) is that they establish and monitor safety, efficacy, and quality of the manufactured drug products that patients need. It is important to note that at the manufacturing stage, safety and efficacy are seldom – in fact, almost never – established and/or measured. Establishing the quality of the manufactured products acts as a surrogate for the safety and efficacy; hence, claims are always limited to the quality aspect.
Sampling plans are used extensively throughout organizations regulated by the FDA. Most organizations have a statistical procedure that specifies a certain acceptable quality level (AQL) based on risk. (If not, they should!) However, most individuals just follow the requirements of the procedure without fully comprehending how sampling plans actually work.
Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) will effect their products. However, under the new regulations, no medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.
For many years, the pharmaceutical industry meant “small (usually synthetic) molecules” mixed with various non-active materials and put into capsules or, in the old days, rolled into pills or pressed into tablets. While synthesizing the APIs (active pharmaceutical ingredients), formulating the dosage forms, and analyzing the materials at every step of the life cycle was not always trivial, it was relatively straightforward.
New drug approvals are on the way up, as the FDA approved 11 percent more innovator therapies in 2018 compared to the previous year, spelling good news for both marketing authorization holders (MAHs) and CMOs. Data also shows that small- and mid-cap pharma companies are increasingly turning to outsourcers to manufacture newly approved drugs.
This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes, discussing the important aspects of those devices. In this part, we will examine the various aspects of prefilled syringes with staked-in needles and their impacts. We will conclude with some general thoughts on vendor selection for successful partnership.
The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency’s 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.
One of pharma’s greatest foibles as an industry has been the penchant to focus on the wrong things. We saw this with process analytical technology (PAT), where we focused on the design and implementation of the technology and ignored the impact of foundational material characterization and supplier control. Pharma 4.0 has the potential to fall into the same trap.
This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.
One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.