Challenges with Implementing Pharma Cleaning Validation

Edward A. Steele

Dear Reader,

Welcome to the June 2019 issue of EASeNews, the free newsletter for FDA regulated industries. FDA has been busy with initiatives this month. As you’ll see in our What’s New at FDA section, two of these include FDA’s finalized Guidance for abbreviated drug submissions as well as food contact notifications products that come into contact with infant formula and human milk. Additionally, FDA announced the decision to extend the registration period for the Voluntary Qualified Importer Program (VQIP) for fiscal year 2020 until July 31, 2019. Annual benefits will then take effect beginning October 1. VQIP is a voluntary fee-based program established by the FDA FSMA that provides for expedited review and importation of human and animal foods into the US for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. If you feel your company qualifies for VQIP or would like an assessment or assistance completing the application process, please feel free to contact me.

I am happy to say EAS has announced our fall line-up of compliance seminars taking place in Irvine, CA. We are offering Dietary Supplement Labeling November 12-13, 2019 Food Labeling November 14-15 and Dietary Supplement GMPs November 14-15. We invite you to register now for early-bird pricing.

We welcome two new consultants this month, Tom Jonaitis and Veronica Ortiz de Montellano, both of whom will be of invaluable assistance particularly to clients working with both USFDA and Health Canada as well as firms operating in Mexico who export products to the US.

Our issue of the month is written by Miguel Montalvo and discusses some of the many challenges with pharmaceutical Cleaning Validation. This article is a condensed version of a full-length feature published by the International Society of Pharmaceutical Engineering’s website, ISPE iSpeak. EAS consultants are pleased to provide monthly articles for ISPE iSpeak readers on a variety of topics pertaining to the pharmaceutical and OTC-drug industry. Our Ask the Expert is written by Robert Fish, Independent Advisor for Quality and Compliance and discusses Adverse Events Reporting requirements; and our Did you Know covers EAS capabilities with Contract Research Organizations (CROs) which are heavily utilized and a lifeblood for companies conducting safety studies in the preparation of food additive submissions.

We have two complimentary webinars coming up in June – on June 18 independent consultant Mehrdad Tajkarimi, PH.D. and Leann Chuboff of SQFI will discuss the food fraud puzzle. This webinar is co-sponsored by Food Safety News magazine. On June 20 Bryan J. Coleman, Senior Director for Drugs and Devices will present on GMPs for OTCs and how to improve compliance. We hope that you join us for these and watch any of our previous webinars available on-demand on the EAS website, including May’s webinars on cosmetics claims and how FDA views certain terms when considering whether a product to be a cosmetic or unapproved new drug; and compliance with 21 CFR Part 11.

Thank you as always for your interest in EAS and please feel free to share this newsletter with your colleagues.

Sincerely,

Edward A. Steele Signature

Edward A. Steele

Posted in 2019, 2019 June, EASeNews, From the Desk of the Chairman.