This year’s ISPE Annual Meeting and Expo in Orlando highlighted a number of key topics and trends in our industry’s digitization journey. These covered everything from industry progress with manufacturing and laboratory automation and digitization to trends in new technologies like blockchain and ways to modernize quality organization and systems to be digital future ready. […]
It is evident from reviewing recent health agency citations that the FDA expects that firms have a deep understanding of any systems that generate data/records and that this is reflected in the firm’s lifecycle management of those systems. What does that mean, in a practical sense? Well, a component of this understanding must extend to […]
Within the draft ICH Q14 “Analytical Procedure Development” guidance document (here), Section 6 refers to the Analytical Procedure Control Strategy. This should be developed prior to and confirmed via Analytical Method Validation. A key component of the Analytical Procedure Control Strategy is System Suitability (SST), but the guidance document also makes reference to sample suitability: […]
“At the end of a wrench, is a patient.” The tragic events that happened twelve years ago aboard the Deep Water Horizon (yes, the one that the movie was based on) reinforced a sacred rule – accountability cannot be outsourced. For those who are not aware, of the approximately 126 personnel on board, only 7 […]
When reviewing health agency citations, investigators are naturally concerned when observing cases of data invalidation during investigations and may well question the motives/justification accordingly. This can lead to some uncomfortable exchanges between firms and health agencies! So how should a laboratory protect themselves from such a situation? First, you want to ensure that, per your […]
The FDA issued its final guidance on Field Alert Reports (FARs) today (here). This guidance finalizes the draft guidance of the same title issued on July 19, 2018. FARs have been the subject of much misunderstanding and interpretation regarding when, what, how, and where reports should be sent. I can’t tell you how many times […]
With the news that domestic inspections are back on track the question comes with what is the backlog and how long will it take to slug through the outstanding inspections work? Question number 2 is then what do we anticipate seeing from these new domestic inspections? With it being over a year+ (March 2020) since […]
John Darby, M.Sc., Senior Director of Lachman Consultants, wrote a recent article for Contract Pharma applying the principles of Quality Risk Management to get medicines to market faster. Here is a brief excerpt from the article: “As vaccine development progresses globally to address the coronavirus pandemic, assurance of manufacturing capability to address supply needs is […]
This morning I read Joe Graeden’s (The People’s Pharmacy) article titled “Can You Trust Generic Drug Quality” (here) and, as a former longtime senior official at the FDA who worked in the Office of Generic Drugs and have consulted for the industry for over twenty-five years, I had a kind of knee-jerk reaction and wanted […]
As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]
