Differences Between a GMP and Non-GMP Lab – Part 2

Method Development One of Velesco’s specialties is Analytical Method Development. Quite often, we receive a new compound from a client and are asked to develop a formulation and/or HPLC method to be used for analysis.  Sometimes the client will send bits of a method and other times we are able to start from scratch.  When starting from scratch, the lead scientist researches the compound to...

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Stability Indicating HPLC methods – part 1

When we are hired to develop a stability indicating method for our clients, what do we do? The types of questions that need to be addressed depends on the stage of development that the method will be used for.  First a few basic definitions. What is a stability indicating method? A stability indicating method is a quantitative test method that can detect possible degradants and impurities of...

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Differences Between a GMP and Non-GMP Lab – Part 1

Greetings! I was hired on with Velesco earlier this summer after several years of work in cGMP pharma labs, both contract and manufacturing-related. Coming from a cGMP (current Good Manufacturing Practices) background, I’ve noticed a few differences in the way the lab operates when not confined to GMP regulations.  In the next couple of posts, I will discuss these differences. Coming from cGMP...

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Ophthalmic Drug Products – Recent Webinar and Velesco’s Capabilities

The Velesco team recently attended an ophthalmic drug product webinar.  The training titled ‘Ophthalmic Products – Quality and Performance Tests’ was presented by Margareth R.C. Marques, M.Sc., PhD., USP Senior Scientific Liason.  This webinar was of interest to us due to our extensive experience with ophthalmic drug products which includes analytical method development, small scale...

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‘Design Validation Protocol and Acceptance Criteria for Chromatographic Methods’ webinar

The Velesco team recently attended a validation webinar from the comforts of our conference room here at the MLSIC facility.  The training titled ‘Design Validation Protocol and Acceptance Criteria for Chromatographic Methods’ was presented by Kim Huynh-Ba of Phamalytik.  This webinar caught our attention as we’re always keen to keep up our knowledge on regulatory requirements and...

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It’s That Time of Year – Preventative Maintenance and Calibrations

We’ve come to that time of year again, when our HPLC systems are due for their preventative maintenance and calibration.  We have 6 HPLC systems all staggered within a 3 month window for calibrations and preventative maintenance.  It’s fun to be able to work on the instrument – take it apart, replace and clean parts, and put it back together again.  Having worked at a large company...

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