Vector Illustration of a Happy Thanksgiving Celebration Design with Cartoon Turkey and Autumn Leaves

This Turkey Wants to Wish You a Happy Thanksgiving

Whether you are into tofurkey, real turkey, ham or whatever floats your boat, all of us at Lachman Consultants want to take a moment to wish you and yours a happy Thanksgiving.  At this time of year, we all need to take stock (no pun intended) of our family and friends and realize that, while we all have difficult jobs,

pharmaceutical industry. Production line machine conveyor at factory with bottles

Developments in Continuing Process Verification

The key to developing a practical approach to all phases lies in the establishment of Critical Quality Attributes (CQA) for the drug product and assignment and monitoring of Critical Process Parameters (CPP) that have a direct effect on the performance of the process with regard to the CQA. At the PDA Annual Meeting last week, Scott Bazzone, Senior Manager of Quality Assurance Validation at Pfizer presented the approach that is used there with regards to establishing the risk significance or Z Score of a CPP to the CQA.

Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.

Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.

Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.

Particulate Matter in Parenteral Products – Why So Much?

Last week while waiting for my flight home at an airport on the east coast, I decided to look at the recalls listed on the CDER web page. I realize that I have read about a number of recalls of parenteral products recently and those recalls were for a number of different firms, but what caught my attention was that 12 of 25 recalls listed were for visible particulate matter (including glass particles).
While I am not a manufacturing expert by any stretch of the imagination, I started to wonder why this might be.

Guidance Documents in the Works for 2014

CDER published its yearly Guidance Agenda today giving the industry a look at what to expect for the coming year in terms of issuance of documents. This yearly exercise, while not guaranteeing that all of the guidance will actually be completed, provides a nice look into the important topics that CDER is planning to expound upon for the benefit of transparency.

Is Part 11 Dead? Part 1 of a series– Electronic Records

Hardly!  But Part 11 (21 CFR Part 11), which applies to records in electronic form and the use of electronic signatures required by predicate rule (i.e., those records required to be signed by GMP regulations), has been scrutinized and discussed among regulators and the industry over the years, and the industry is still waiting on the final revised ruling.