IVT Laboratory Week Jerry Lanese. Ph.D. The Lanese Group, Inc The Lanese Group, Inc.

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1 IVT Laboratory Week-2015 Jerry Lanese Ph.D. The Lanese Group, Inc. 1

2 Name Job What brought you here. 2

3 FDA interest in Quality Metrics What are Quality Metrics Quality metrics FDA will request The impact of the FDA expectations on the pharmaceutical firm An outsider s prospective What is ahead 3

4 Request for Quality Metrics Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Tara Gooen Bizjak at or (CBER) Office of Communication, Outreach and Development at or Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2015 Pharmaceutical Quality/CMC Current Good Manufacturing Practices (CGMPs) 4

5 5

6 A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight. Janet Woodcock 6

7 Food and Drug Administration Safety and Innovation Act July

8 One Hundred Twelfth Congress of the United States of America AT THE SECOND SESSION Begun and held at the City of Washington on Tuesday, the third day of January, two thousand and twelve An Act To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish userfee programs for generic drugs and biosimilars, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the Food and Drug Administration Safety and Innovation Act. SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. (a) TABLE OF CONTENTS. The table of contents of this Act is as follows: 8

9 Gives the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; Promotes innovation to speed patient access to safe and effective products; Increases stakeholder involvement in FDA processes; and Enhances the safety of the drug supply chain. 9

10 Requires FDA to replace the previous twoyear drug inspectional frequency requirement with a risk-based inspection schedule for domestic and foreign drug facilities. Inspection criteria include the establishment s compliance history and the inherent risk of the drug being manufactured. FDA is developing risk-based methodologies for inspections to reflect the statutory criteria and is working to establish common risk principles across the various Centers. 10

11 Allows FDA to obtain records from a drug manufacturer in lieu of or in advance of an inspection. Request for records must include a description of the records requested Records shall be provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner. FDA is developing procedures to employ this new authority, including. determining the type of records it may wish to request under this section. 11

12 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 submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Tara Gooen Bizjak at or (CBER) Office of Communication, Outreach and Development at or Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2015 Pharmaceutical Quality/CMC Current Good Manufacturing Practices (CGMPs) 12

13 FDA is providing industry an incentive to requiring industry to proactively understand and measure quality, identify problem areas, and implement appropriate corrective and preventive actions. 13

14 14

15 Standards of measurement by which efficiency, performance, progress, or quality of a plan, process, or product can be assessed. ition/metrics.html#ixzz3sdvimqsr 15

16 Standards of measurement by which quality of a plan, process, or product can be assessed. 16

17 Baldridge

18 Management by Fact Compels the organization to measure performance both inside the organization and in its competitive environment Uses data and analysis in decision making Challenges the organization to extract larger meaning from data and information Baldridge

19 19

20 Productivity People Safety (OSHA) Assets Quality Total Productivity Maintenance 20

21 21

22 Cp Cpk First Pass Yield Defects Per Unit Defects Per Million Opportunities (DPMO) Percentage of units ordered that are shipped on a given order. Line Item Fill Rate Percentage of line items, or SKU's, that are shipped on a given orders shipped 100% complete. Shipment On-Time % Shipping Errors Per Shipment Total number of shipping errors Warranty dollars paid during a period divided by the net sales for that same period. Warranty Claims per Unit Total number of warranty claims Survey Complaints (TGW's) per Unit (or per 1000) The number of complaints, Customer Satisfaction 22

23 1: Yield. 2: Scrap Rate 3: Supplier Defect Rate 4: Supplier Chargebacks 5: Customer Complaints Quality-Metrics-for-the-Plant-Manager-s- Dashboard, accessed 11/26/15 23

24 24

25 25

26 26

27 Under Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) Public Law No , FDA may require the submission of any records or other information that FDA may inspect under section 704 of the FD&C Act, in advance or in lieu of an inspection, 27

28 While FDA recognizes the value of quality metrics, we also recognize that individual data points and metrics are not solely indicative of the state of quality of the establishment or products. Rather, FDA intends to use quality metrics data in context with other sources of quality data, as further described in this guidance. 28

29 CDER and CBER are committed to supporting the modernization of pharmaceutical manufacturing as part of the Agency s mission to protect and promote public health. In 2002, FDA launched an initiative entitled Pharmaceutical cgmps for the 21st Century: A Risk-Based Approach, to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system. 29

30 The initiative was published with several goals, including ensuring that regulatory review, compliance, and inspection policies continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry. CDER has promoted a vision of a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight. 30

31 The quality metrics program is expected to play an important role in addressing riskbased inspection scheduling and in the prediction, and potential mitigation, of drug shortages. 31

32 32

33 33

34 FDA used the following criteria to select the quality metrics that it intends to calculate using requested data when this guidance is final: metrics should be: 1. Objective 2. Subject to inspection under section 704 of the FD&C Act, and 3. Valuable in assessing 1. the overall state of quality of the product and process 2. commitment to quality by the manufacturer, and the health (i.e., effective functioning) of the associated PQS, 4. While avoiding any undue reporting burden 34

35 FDA intends to request quality metrics data from owners and operators of each establishment that is: (1) required to register under with FDA under section 510, and (2) engaged in the manufacture, preparation, propagation, compounding, or processing of the FDF of a covered drug product, or an API used in the manufacture of a covered drug product. FDA Quality Metrics Guidance 35

36 For purposes of these requests, a covered drug product would mean a drug product that is: subject to an approved application under section 505 of the FD&C Act or under section 351 of the PHS Act. marketed pursuant to an OTC monograph. marketed unapproved drug product. FDA Quality Metrics Guidance 36

37 FDA intends to ask industry to submit one report for each FDF and one report for each API of a covered drug product, which includes quality metrics data from each covered establishment that has the requested data. FDA Quality Metrics Guidance 37

38 FDA believes that the quality control unit (QCU)18 in each reporting establishment for an FDF or API will generally be best positioned to compile reports for submission to FDA, given the unit s responsibilities and authorities for the oversight of drug products as described in 21 CFR FDA Quality Metrics Guidance 38

39 The number of lots attempted of the product. The number of specification-related rejected lots of the product, rejected during or after manufacturing. The number of attempted lots pending disposition for more than 30 days. The number of OOS results for the product, including stability testing. The number of lot release and stability tests conducted for the product. 39

40 The number of OOS results for lot release and stability tests for the product which are invalidated due to lab error. The number of product quality complaints received for the product. The number of lots attempted which are released for distribution or for the next stage of manufacturing the product. If the associated APRs or PQRs were completed within 30 days of annual due date for the product. The number of APRs or PQRs required for the product. 40

41 Calculate Quality Metrics 41

42 1-x x = number of specification-related rejected lots in a time frame divided by the number of lots attempted by the same establishment in the same time-frame. 42

43 Interpretation The fraction of lots completed successfully Desired result 1.00 Indicator of the effectivity of the production unit Lagging 43

44 As a leading Quality improvement tool Calculate lot acceptance rate by the month, each month. Trend Goal improvement each month 44

45 The number of product quality complaints received for the product divided by the total number of lots of the product released in the same timeframe 45

46 Interpretation The number of complaints per released lot An indicator of the overall effectiveness of the Quality System Desired result 0 Lagging 46

47 As a leading Quality improvement tool Maintain a running trend of complaints per lot. Establish a goal of reduction of the trend 47

48 The number of OOS test results for the finished product invalidated by the establishment divided by the number of OOS results divided by the total number of tests performed by the establishment in the same timeframe 48

49 Interpretation The fraction of invalidated OOS results per test run. An indicator of the effectiveness of the QC laboratory Target 0 lagging 49

50 As a leading Quality improvement tool Calculate and trend each month: Fraction of invalidated OOS results by product Fraction of OOS results by analyst Investigate and CAPA for high values. 50

51 The number of APRs or PQRs completed within 30 days of annual due date at the establishment divided by the number of products produced by the establishment 51

52 Interpretation Fraction of product reviews completed on time Not a product-specific metric Goal - 0 An indicator of the Quality Culture A lagging indicator 52

53 As a leading Quality improvement tool Identify late Product Reviews as a deviation Investigate; CAPA 53

54 54

55 Interpretation An indicator of the corporate commitment to Quality An indicator of a robust Quality System Identified whether senior management is engaged in the assessment of Quality An indicator whether quality and manufacturing share the knowledge of the assessment 55

56 56

57 Interpretation An indicator of the robustness of the Quality System 57

58 A yes or no value of whether the establishment s management calculated a process capability or performance index for each critical quality attribute (CQA) as part of that product s APR or PQR. A yes or no value of whether the establishment s management has a policy of requiring a corrective action or preventive action (CAPA) at some lower process capability or performance index. If yes to the above question what is the process capability or performance index that triggers a CAPA? If no to the above question please do not respond. 58

59 Process capability Interpretation An indication of the use of process capability, or other statistical tools, to monitor processes and identify areas for improvement 59

60 60

61 ICH Q10 Pharmaceutical Quality System Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuance Investigational Products GMP PQS Elements Enablers Management Responsibilities Process Performance and Product Quality Monitoring System Corrective Action/Preventive Action (CAPA) System Change Management System Management Review Knowledge Management Quality Risk Management 2015 The Lanese Group, Inc. 61 ICH Q10 4 June 2008

62 ISO Baldridge TQM Shingo Lean 62

63 You Your unit Your company 63

64 1. Valuable in assessing 1. the overall state of quality of the product and process 2. commitment to quality by the manufacturer, and the health (i.e., effective functioning) of the associated PQS, 2. While avoiding any undue reporting burden 64

65 Will the Quality Metrics program drive the pharmaceutical industry to: become maximally efficient agile flexible reliably produce high quality drugs without extensive regulatory oversight. 65

66 IVT Laboratory Week-2015 Jerry Lanese Ph.D. The Lanese Group, Inc. 66

67 Jerry Lanese Ph.D. The Lanese Group,, Inc Catalina Leawood, KS

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