July-August 2016 Newsletter Banner
Your Bi-monthly Industry News & Updates
The Protocol Link Newsletter took a summer break, but we are back and ready to continue providing you with industry updates and news you may have missed!

In this edition, you'll find our noteworthy links, articles from Protocol Link's own Director, Dr. Christine-Shumard Sauer, Vice President, Dr. Daniel J. Hoch, and we closeout with a word from our COO, Ginni Doshi.
Noteworthy Links
New eMDR Webpages to Assist with Submissions
Electronic Common Technical Document (eCTD) v4.0 Elemental Impurities in Drug Products (Draft Guidance)
Better Evidence on Medical Devices

 Office of Generic Drugs (OGD) Annual Report 2015
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the FD&C Act Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act
Reducing Medical Errors for Drugs and Combination Devices

Recently the FDA published two Guidance Documents, " Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors" (CDER, April 2016) and " Draft Guidance for Industry and FDA Staff: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development" (CDRH, February 2016) which relate to assessing human interaction in product design of drugs, biologics, and combination devices with the ultimate goal of reducing errors with their use.
Data Integrity - FDA Draft Guidance

The concerns over data manipulation and other data integrity questions has resulted in the US Food and Drug Administration (FDA) issuing a new draft guidance on the topic.

The guidance is structured in a question and answer format including defined terms on data as they relate to current good manufacturing practice (cGMP) records, as well as recommendations on when workflows on computer systems need to be validated, and how to ensure electronic master production and control records (MPCR) are monitored and controlled.

A Word From Our Staff

"The FDA has recently been coming down hard on off-shore pharmaceutical manufacturers; common instances in FDA 483 observations include data integrity, falsification of records, and lack of quality. As consultants, Protocol Link plays an important role to help these clients balance the manufacturing of a quality product in an efficient manner while maintaining FDA compliance. Our experience has taught us that it is critical to engage in an in-depth dialogue and to immerse ourselves into our clients' culture and work environment to identify potential misinterpretations which can be attributed to cultural differences. This helps to reduce unnecessary loss of time, labor, money, and most importantly, allows our clients to provide both quality and compliant products to the general public. Our end goal is to help empower our clients to approach the FDA to better understand their true gaps, instead of leaving it up to interpretation."

Ginni Doshi
Chief Operating Officer
Protocol Link, Inc.
847.549.0390
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