The PDA published Technical Report 84, Introducing Data Integrity Requirements into Manufacturing and Packaging Operations (here), which reaffirms that Data Integrity is not only a concern for the laboratory but for any aspect of the pharmaceutical industry where data/records are generated and handled. There are excellent tools within the document as it applies to the […]
Two executives of a dietary ingredient company were sentenced to sixty months and twenty-four months in prison, respectively, for their part in the distribution of two products, Jack3d and OxyElite Pro, touted as workout weight-loss supplements, both containing DMAA, according to a Department of Justice release (here). The FDA had warned consumers about the dangers […]
Since the start of the pandemic when travel was limited, Lachman Consultants has been performing virtual inspections. In fact, we have performed audits and inspections at the same rate as we did before the pandemic, only now, most of them are remote. We have been at the forefront of implementing effective state-of-the-art solutions. During this […]
The history of the issue of the ”intended use” regulations goes back to 2015, as explained in this 39-page pre-publication version of the Federal Register Notice (here), and it is quite an interesting read. The main issue surrounds the notion that, if a firm knows its product is being used for a use not in […]
When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]
There has been a lot of discussion about the need to retain up to five times the amount of test and reference drug product to perform release testing as reserve samples for products used in in vivo or in vitro bioavailability (BA) or bioequivalence (BE) testing for NDA or ANDAs products. The requirements were at […]
How has COVID 19 changed your organization? Do you have fewer or newer employees? Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving? Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA? […]
A Department of Justice press release (here) announced a 19 count indictment against 9 individuals “with conspiracy to commit mail and wire fraud, mail fraud, wire fraud, aggravated identity theft, conspiracy to defraud the United States, and failure to maintain adequate records.” Basically, the press release goes on to describe fraudulent activities relative to the […]
In 2019, FDA issued the first Warning Letter for violations of the Drug Supply Chain Security Act, signaling its heightened attention to supply chain and distribution issues. Since DSCSA was enacted in 2013, various provision have come into effect. It is important for companies not just to understand the law’s requirements, but also how to […]
Be careful out there, warns FDA, as they continue to see hand sanitizers containing potentially deadly methanol (as well as other toxic substances). The FDA has a DO NOT USE list of hand sanitizers (here) and issued another warning about assuring safe use of these products in a press release on July 27, 2020 (here). […]
