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Industry Trends/Regulatory

Manufacturers of drug products and container/delivery systems must comply with ever-changing governmental regulations (e.g., US FDA) and industry guidances (e.g., USP). Understanding the nature of these regulations/guidances, and their future direction, is essential to long-term compliance. This section presents papers on these topics.

Regulations And Guidelines For Mapping Temperature And Humidity Of Pharmaceuticals. 

B. McDuffie.  Pharmaceutical Online (2017)


This article briefly reviews different regulations applicable to North America regarding environmental mapping of drug products.

Link: https://www.pharmaceuticalonline.com/doc/regulations-and-guidelines-for-mapping-temperature-and-humidity-0001?vm_tId=2023050&user=d0d2b75e-cba1-47c0-adb6-bf1412887887


The Importance of Assuring Quality Throughout the Lifecycle
Richard Freeman Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality


This presentation addresses FDA's view on how effectiveness of a drug product through its life cycle depends upon quality of manufacturing and packaging. Critical areas are: methods, machines, materials, measurements, environment, and people. Numerous examples are given of problems resultant from failure to manage these areas properly.

Link: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM518520.pdf


Introduction to the Drug Master File (DMF)

Arthur Shaw, FDA DMF Expert


This presentation reviews the basic concepts of two vehicles critical in the pharmaceutical industry: Drug Master File (DMF) and Letter of Authorization (LOA).  A DMF is a submission of information to the FDA to permit the FDA to review said information in support of a third party's application without revealing the information to the third party.  DMF's usually cover the chemistry, manufacturing and controls of a components of a drug product (e.g., drug substance, excipient, packaging material). An LOA is a document issued by the DMF submitter to the third party authorizing FDA to review DMF and third party to incorporate DMF information by reference in an application.

Link: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM279666.pdf


United States Pharmacopia: Compendial Effort to Revise Packaging Material Standards: Glass, Plastic, Elastomer, Metal and Other

Desmond G. Hunt, M.S., Ph.D. Principle Scientific Liaison


This presentation was delivered at the November 2016 AAPS meeting by Dr. Desmond Hunt, Principal Scientific Liaison at United States Pharmacopeia.  It considers changes to select USP standards that emphasize risk-based testing of drug product packaging.  Areas addressed are plastic containers, glass containers, elastomeric closures, metals in packaging, and biological reactivity testing.

Link: USP Compendial Effort to Revise Packaging Material Standards


Implementation of ICH Q3D Elemental Impurities Guideline:  Challenges and Opportunities.

A. Teasdale, et al.  Pharmaceutical Technology, 39 (3), 36-49 (2015)


This article discusses ICH Q3D (Guideline for Elemental Impurities) as it relates to evaluations for impurities in drug products – specifically advocating a risk-based approach.  Recommended analytical methods and new thresholds for selected metals are also discussed.

Link: http://www.pharmtech.com/implementation-ich-q3d-elemental-impurities-guideline-challenges-and-opportunities


Elemental Impurities – Lifecycle Management. 

P. Walsh (Merck & Co., Inc.)  PQRI/USP Elemental Impurities Workshop (November 2016)


This presentation discusses how changes in products, processes and components may impact risk of elemental impurities in drug products, and the subsequent effect on lifecycle management.

Link: http://pqri.org/wp-content/uploads/2016/11/4-PQRI-Elemental-Impurities-Lifecycle-Walsh.pdf


Elemental Impurities – Parenteral Dosage Form Case Study – Approach and Challenges. 

J. Mason (Eli Lilly and Company).  PQRI/USP Elemental Impurities Workshop (November 2016)


This presentation considers the assessment of risk of impurities in a parenteral drug product from various sources: equipment, water, gases, excipients, drug substances, and container closure systems.

Link: http://pqri.org/wp-content/uploads/2016/11/3-PQRI_Mason.pdf


FDA Perspective and Expectations for Control of Elemental Impurities in Drug Products. 

D. Christodoulou (CDER/OPQ Office of New Drug Products). PQRI/USP Elemental Impurities Workshop (November 2016)


This presentation discusses FDA’s approach to consideration of critical factors in controlling elemental impurities:  timelines, documentation, GMP expectations, and methods validation.

Link: http://pqri.org/wp-content/uploads/2016/11/4-EI-FDAperspectivedPQRI.pdf


Strategies for Determination of Elemental Impurities in Complex Samples. 

D. McClenathan (The Procter and Gamble Company).  PQRI/USP Elemental Impurities Workshop (November 2016)


This presentation gives an overview of the types of analytical methodologies, and sample preparation techniques, that are useful in identifying elemental impurities.

Link: http://pqri.org/wp-content/uploads/2016/11/McClenathan-PQRI-2016-Nov-for-posting.pdf

Website for PQRI conference (included here for reference)