In the first article dealing with our surveys, we concluded that not all of the guidances issued had been implemented completely.  Even when they had been implemented, the implementation did not take advantage of all the potential.  For instance many companies were reluctant to  not work on certain technical areas even though their risk analysis indicated that these same areas were relatively unimportant and had little impact on product quality and patient outcome.  And why was that?  Perhaps they did not believe their analysis.  Perhaps they were afraid of inspectors disagreeing.

The second article (Part 2 of the survey) showed that even though guidances had been implemented, the impact on some of the most troublesome elements of the QMS was not as effective as hoped.  Some if you find your company not gaining as much traction as hoped, you are not alone in struggling to become more effective.

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In a recent article we presented data showing that QbD has been difficult to implement. This new articles teases apart the issues based on public data and interpretation. Enjoy the read. The link is here

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This has always been a question people ask.  As a consultant i see a slice of the industry that interacts and works with me, so I have my opinions.  However, a company that employs me may not represent the average company.  So a colleague of mine, Peiyi Ko, and I decided to conduct a survey asking these questions.  we used Survey Gizmo as the survey tool and LinkedIn Groups as the interface.  These 40 questions were posed and because of the interesting answers we got, we are publishing them in two parts.  This post has the first part published in Pharmaceuticalonline.  In this part, we examine the implementation of various guidances and regulations.  The second will feature how ell they have impacted the company Quality Management System.

The second part will be published in a couple of months.  Bookmark my website so you will see it when the next is posted.

Happy reading

Posted in audits, Clinical Manufacturing, Commercial Manufacturing, Contract Manufacturing, FDA Guidance, GMP, Process Validation, Quality Agreements, Quality by Design, Quality Management Systems, Risk Management, Webinars| Tags: Services, SOPs|Leave a comment

I just had an article describing the Compounding industry and what the FDA is doing about it. Here is the link.

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During the last few months the European Medicines Agency (EMA) has issued a series of revisions to Annexes and Guidances

Specifically, the following

Annex 15 – Validation and Qualification

Annex 16 – Certification by a Qualified Person and Batch  Release

Annex 17 – Real Time Release Testing

Guidance to Industry: Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

To understand what they contain and what it means, I refer you to an article I wrote recently in

Pharmaceutical on line  and

Bioprocess on line

Posted in Clinical Manufacturing, Commercial Manufacturing, FDA Guidance, GMP, News, Process Validation, Quality by Design, Quality Management Systems, Risk Management| Tags: Services|Leave a comment