Updates on Quality Metrics - Industry Perspectives Dan Snider Vice President, Research and Development Mylan Inc.

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1 GPhA/FDA FALL TECHNICAL CONFERENCE Updates on Quality Metrics - Industry Perspectives Dan Snider Vice President, Research and Development Mylan Inc.

2 Disclaimer This presentation contains a summary of the opinion and perspective from GPhA member industry representatives on the topic of Quality Metrics. This presentation does not necessarily represent the opinion of the presenter nor Mylan Inc..

3 What is Quality?

4 What is Quality? Preamble to CGMP uses the word quality greater than 100 times. The first time Under the Federal Food, Drug, and Cosmetic Act, a drug is deemed to be adulterated unless the methods used in its manufacture, processing, packing, and holding, and the facilities and controls used therefor, conform to current good manufacturing practice so that the drug meets the safety requirements of the act and has the identity and strength and meets the quality and purity characteristics that it is represented to have. The regulations are being updated and made more explicit, and therefore less subject to varying interpretations, to assure that all members of the drug industry are made aware of the level of performance expected of them to be in compliance with the act. EFFECTIVE DATE: March 28, 1979.

5 What is Quality? Preamble to CGMP uses the word quality greater than 100 times. The first time Under the Federal Food, Drug, and Cosmetic Act, a drug is deemed to be adulterated unless the methods used in its manufacture, processing, packing, and holding, and the facilities and controls used therefor, conform to current good manufacturing practice so that the drug meets the safety requirements of the act and has the identity and strength and meets the quality and purity characteristics that it is represented to have. The regulations are being updated and made more explicit, and therefore less subject to varying interpretations, to assure that all members of the drug industry are made aware of the level of performance expected of them to be in compliance with the act. EFFECTIVE DATE: March 28, 1979.

6 FD&C Act Chapter V: Drugs and Devices 351. Adulterated drugs and devices What is Quality? A drug or device shall be deemed to be adulterated (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess;

7 FD&C Act Chapter V: Drugs and Devices 351. Adulterated drugs and devices What is Quality? A drug or device shall be deemed to be adulterated (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess;

8 What is Quality? It is not just conformance to specifications. The words identity and strength, and meets the quality and purity characteristics include: Identity is the identification specification. Strength is the potency specification. Purity includes the impurity specifications. Quality seems to be somewhat undefined.

9 What is Quality? Food and Drug Administration Safety and Innovation Act (FDASIA) SEC ENHANCING THE SAFETY AND QUALITY OF THE DRUG SUPPLY. Section 501 (21 U.S.C. 351) is amended by adding at the end the following flush text: For purposes of paragraph (a)(2)(b), the term current good manufacturing practice includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.. This is much more clear. Quality is everything.

10 Where is Quality Now?

11 Where is Quality Now? There is a major shift towards innovation and continuous improvement with the Pharmaceutical cgmps in the 21 st Century. Applicable Guidance Include: ICH Q1 through Q11 Q8(R2) Pharmaceutical Development- How to describe the development of a product. Q9 Quality Risk Management - Assessing risks to the Quality of a product. Q10 Pharmaceutical Quality System - An overarching system is required. Why is this all necessary?

12 Where is Quality Now? There is a major shift towards innovation and continuous improvement with the Pharmaceutical cgmps in the 21 st Century. Applicable Guidance Include: ICH Q1 through Q11 Q8(R2) Pharmaceutical Development- How to describe the development of a product. Q9 Quality Risk Management - Assessing risks to the Quality of a product. Q10 Pharmaceutical Quality System - An overarching system is required. Why is this all necessary? Quality is Everything!

13 Understanding Quality Today Quality is everything. Concept of modern quality system Robust quality system Quality by design and product development (lifecycle) Quality risk management CAPA Change control Idea of separate quality unit management review of product, system, and process quality Essential leadership to establish company-wide commitment to quality and for the performance of quality management system

14 Understanding Quality Today In order for FDA and Industry to work to benefit the public, Quality Metrics should be developed. Why? Because Quality is Everything.

15 Quality Metrics What metrics are important to FDA and most beneficial for Industry to measure?

16 Examples of Potential Metrics Batch Failure Rate Right First Time OOS / Laboratory Failure Investigation Rates Definitions and foundation matters! Standards for Sampling/Acceptance Plans Referenced from: Russ Wesdyk 2013 CMC Presentation Quality Metrics

17 Industry Reports - Minimal Each FEI site reports the following (per CY) stratify by product and/or application number. # of lots attempted # of lots rejected # of lots reworked or reprocessed # of lot release tests conducted # of Out of Specification Results (# of lot release tests failed) # of lot release results invalidated because of laboratory error/anomaly (# of lot release test outcomes reversed due to lab error) Data requirements from industry are minimal Referenced from: Russ Wesdyk 2013 CMC Presentation Quality Metrics

18 Quality Metrics FDA constraints: Records made available under 704, to collect under 706, to prepare risk based inspection schedule under 705 (FDASIA) Metrics need to apply across all sectors (Generic, Rx, OTC) Metrics need to be Quantitative and OBJECTIVE Eliminate unintended consequences which incentivize the wrong behaviors. Relevant to patient safety and health Common ground, FDA and industry need consensus

19 FDA Potential Metrics 1. Batch Failure Rate 2. Right First Time 3. OOS / Laboratory Failure Investigation Rates What can GPhA do to drive success? The process benefits by industry providing input both positive and negative.

20 Alignment on Fundamental Definitions How exactly do we define when differences exist?

21 We need to all speak the same language How do we define? What is a batch? What is a lot? What is final product disposition? What is a rejection?

22 Challenging Questions Lets do our homework, lets meet on common ground.

23 Pulse Check Is there alignment within your company on definitions? What metrics do you measure? How do you calculate these metrics? Do you stratify metrics by product or site? How do these benefit public health? How would these benefit the FDA? How do these benefit the industry?

24 What do we have in common? Where are our differences? Should we, the generic industry leaders, do the math and provide the algorithms? What method of measurement do we use? What level of statistical confidence do we use? What can we bring to the table to help GPhA solidify these sorts of definitions?

25 Food for Thought Who is willing to lead??? Companies Industry FDA

26 Thank You.

Request for Quality Metrics Guidance for Industry

Request for Quality Metrics Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be