Author: Nigel J Smart PhD

So, the idea of traveling domestically here in the US to perform your supplier/vendor audits is still a questionable practice. The fact is that although some companies are opening up the allow site visits, the vast majority are still refusing entry to their facilities and most of the staff that handle audits are working remotely themselves.This could be extremely disruptive if you are expecting to keep your clinical or commercial manufacturing on track.Now, add in the dependency upon foreign manufacturers and their overseas facilities as CDMO’s for many clinical manufacturing programs, and you amplify the magnitude of the problem,...

So, you have come to the end of your inspectional process and now you are sitting in your conference room with the FDA inspectors waiting for them to tell you how you have done. This is a stressful time, but if you done your homework and prepared well for the inspection, there should be no reason why you should fear the outcome.Remember, the inspection is a snapshot of your compliance program and not an absolute measure of everything associated with that program, that would be impossible in the time to do that thoroughly. So, with this in mind, your...

Tips to improve your experience by Nigel J Smart PhD During this time of modified practices there is still the need to keep our businesses moving along. One critical area relates to supply inspections, especially where CMO’s are being used to make investigational medical products all licensed products. Social isolation and distancing continue to make this a challenge to assure compliance, but provided a well-planned strategy is followed, it is possible to keep appropriate oversight responsibilities in place and to maintain quality compliance at the required levels. Although our technique for dealing with this has been covered in a...

As the Covid -19 pandemic rages on, there is now a scramble by the governments of the world to have these vaccine candidates manufactured in unprecedented quantities. With some 20+ vaccines in various stages of development those companies developing the product candidates are forming alliances with contract manufacturing companies and other pharmaceutical companies with available capacity to produce the billions of doses needed globally. Today was announced one such venture between J&J and “Emergent” with manufacturing capacity in the Baltimore area. The race is on then to make a reliable quality product and although there is capacity, locking this...

With a booming level of sales of CBD oil in the dietary supplement field, the question needs to be asked what do manufacturers need to do to assure that the material meets specification and is made in compliance with cGMP ( Good Manufacturing Practice).Its fair to say, I think, that the traditional producers in this area are largely inexperienced in what is appropriate. Hopefully using this platform, we may enlighten a few producers and assist them in maintaining consumer confidence as well as quality compliance.The major compliance feature in the manufacture of CBD product relates to the extraction process...