Visit with Lachman Consultants at Exhibit Hall E, Booth 626. We hope to see you at The MedTech Conference at the Metro Toronto Convention Center in Toronto, Canada, October 15-17, 2024. It features world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology. This fast-growing event is a gathering of the world’s top medtech […]
ICH Q10 (here) states the following as it relates to outsourcing activities and purchasing materials (hereafter referred to as third party): “The pharmaceutical quality system, including the management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately responsible to […]
Since July 9, 2012, the day that the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 19 Law 112-144) was signed into law, drug products are deemed “adulterated for which a manufacturer processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or […]
There has been turmoil in the world; everything seems to have gone crazy. It’s hard to find faith or even truth in our politicians. Laws have been broken and our democracy was almost broken. But, with the 2022 mid‑year election, we seem to have taken a step back from the precipice. In thinking about our […]
The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop. The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from […]
If our supply chain was weak prior to the pandemic, this global event accelerated its failure. These signals of weakness were laid bare during the pandemic and identified in publications such as the 2019 report “Drug Shortages: Root Causes and potential Solutions” (here). Prior to the Covid PHE, focus on shortages was placed much more […]
During the 2022 PDA Data Integrity Workshop held on September 15th and 16th, in Washington, D.C., the topic of “rewards for meeting Quality Metrics” was mentioned several times. You may have been the recipient of a work-related incentive at one time or another during your career for meeting a Quality Metric or for achieving some […]
At the first in person PDA/FDA Joint Regulatory Conference since the pandemic began, (held September 12-14 in Washington, DC), it was almost impossible to escape the effect that the pandemic had on everyone attending the meeting, regardless of their affiliation. From the inevitable exclamation from presenters at the podium about how great it was to […]
In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD. A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a […]
Today, the FDA advised that it “recently became aware of a nitrosamine impurity, Nitroso‑STG‑19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes mellitus. To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, the FDA will not object to the temporary […]
