Author: Nigel J Smart PhD

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...

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So now you have a Warning Letter or worse, a Consent Decree and you need a strategy to move forward. What do you do?In order to develop a sustainable methodology that will ensure the appropriate outcome, one needs to develop a cGMP masterwork plan that will crystallize key principles and functions that will be used to assure consistent and reliable implementation of remediation activities. This should involve the establishment of lead teams, drawn from the company personnel and third party consultants, that together will take responsibility for the identification and resolution of tasks and activities assigned to remediate a...

At a time when we must be efficient to remain competitive, it is important to set the correct strategy in place to drive that success. This success is both financial and quality compliance related, so it is important to accommodate drivers that address both concerns. Interestingly both are closely tied together so if you are careful with your planning and execution, you can reach your own form of operational near nirvana that can put you in a dominant position in your market. So, with this as the goal let us summarize an approach that can bring success.There are some...