PDA Intro and Overview of Aging and Modernization. Maik W. Jornitz PDA Aging Facility task Force Co-Chair

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1 PDA Intro and Overview of Aging and Modernization Maik W. Jornitz PDA Aging Facility task Force Co-Chair

2 Agenda Review of the Current Situation Observations Aging Facilities Effects Possibilities PDA Initiatives Overview Aging Facility Task Force Status

3 Current Situation 483 Citations FY CFR (a) Cleaning / Sanitizing / Maintenance Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. 21 CFR (a) Calibration/Inspection/Checking not done Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance 21 CFR (a) Training--operations, GMPs, written procedures Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. 21 CFR (b) SOPs not followed / documented Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. 21 CFR Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance].

4 Age can mean sub-optimal processes Risk: Quality issues Unit operation break-down Supply problems Yield losses Sources: web

5 Economic Drivers contribute Healthcare Cost Pressure Generic Competition Shareholder Satisfaction COGS Reduction Single Site High Throughput Low Inventory Reduced Maintenance Reduced CAPEX Lower Labor Costs Drug Shortage 5 Source: Woodcock, Wosinska

6 How do we perform up-dates Continuous improvements or a seesaw approach; the later being probably motivated by regulators and not own initiatives Risk: Quality issues Prolonged upgrade/shut down periods High remediation costs 6 Sources: blog ispe.org

7 Number of active drug shortage The carry-over from previous years still causes a major drug shortage problem Source: IMS Institute for Healthcare Informatics

8 What are the Reasons? Most other causes aggravate the 1 st one Foreign matter in filled product (particulates, fibers etc.) Microbial contaminations Glass breakage/container closure Mislabeling/incorrect product filling Source: FDA

9 Current Situation Aging Facilities If processes are not automated, the precision of manual, human driven steps is crucial Experience Defined Tasks Quality Conscious Dedication Pride Long-term Employee

10 Needed Retrofitting Processes conversion

11 Possibilities Retrofitting Processes 10kL De-risking Higher flexibility Faster turn-around Closed systems Advanced PAT

12 Needed Post Approval Change Guidance Minor Moderate Major Annual Report CBE, CBE30 PAS What is what, can mean: Substantial resources drain Lowering the motivation of change/improvem ent Mothballing facilities The PDA Task Force needs to address change and regulatory scrutiny

13 Agenda Review of the Current Situation Observations Aging Facilities Effects Possibilities PDA Initiatives Overview Aging Facility Task Force Status

14 PDA Initiatives Drug Shortage and Aging Facilities go Hand-in-Hand PDA MANUFACTURING INITIATIVE

15 Aging Facilities - Definitions High process variability Depreciatio n HVAC unable to adjust to changes High degree of manual activities Equipment age Number of Incidences Poor maintenanc e Improper or outdated analytics State of the Art questionable Equimt. spare parts available

16 Aging Facilities Task Force - Coverage Facility Design Risk Assessment Regulatory Analytics Personnel, material, waste flow Processing areas FMEA/HACCP Process improvements Change classifications PAT Tool up-dates Equipment Baseline investments Process changes Post approval change needs Automation Reliability engineering Master planning Training Vulnerability assessment Filings Controls Software validation

17 Task Force Member Composition Small Molecule Industry Large Molecule FDA EMA PIC/S Regulators Aging Facility Task Force Consultants GMP Validation Design A&E firm Vendors Equipment manf.

18 Organization of Task Force Identify Task Force Members Identify Task Force Members Interest by Area Analytics Facility Process Identify Leader for Each Area Analytics Facility Process Identify Task Force Members for Each Area (Task Force Subgroups) Task Force Subgroups Begin Work

19 Organization of Work Draft Scope Complete work on scope and identify desired end product Leaders draft specific topics to be worked on in their area Each Leader works with subgroup to finalize topics to be worked on in their area Task Force Subgroups Begin Work The current focus of the Task Force Subgroups has been on the up-coming workshop

20 Conclusion Aging facilities are a major concern for industry and regulators alike Supply demands are rapidly on the rise, which sets also priorities within the system Modernization is required, but not easily accomplished The aging facility task force complexity and scope requires the division into: Facilities Processes Analytics

21 Thank you!