EFFECTIVE VALIDATION PLANNING IN FONT COLOR, AHAS

Transcription

1 EFFECTIVE VALIDATION PLANNING IN A PRODUCTION FACILITY FONT COLOR, AHAS By: Justin Roose Head Validation Engineer Product Quality Assurance (Global Compliance) 1

2 Session Agenda 1. Instruction 2. Questions 3. Do it! (Exercises) Open-forum training session What do you want to learn? Two-way / Your experiences 2

3 3 Keys to Success Well-Developed Strategy Don t miss anything Proper Resourcing & Support Validation is executed Communication Properly & Efficiently 3

4 Let s not let our success overshadow our how we did it. We had a good plan, and diligence against that plan. This victory wasn t coincidence it was the result of good planning, hard work, and communication. 4

5 Skills & Qualities Leadership Communication Written, Oral, Presentation Project Management Organized, Scheduling, Planning, Coordination Subject Matter Expertise Collaboration & Teamwork Technical Writing 5

6 Types of Validation Cleaning Equipment (incl. Facility & Utilities) Process Verification (Med Device) Sanitizing Validation Packaging Laboratory Equipment Test Methods Control & Information Systems Software

7 Assess & Identify Activities How is each one is impacted? What are the Product, Regulatory, Company requirements? Leverage team expertise & peers Team buy-in & resources How will we prove capable equipment & effective processes? Validation Requirements 7

8 Activities (con t) How to explore & develop capability? Do your homework understand it! Develop plan, schedule & expectations Things go wrong include contingency. Master Validation Plan Organized summary of requirements Written rationale & justification Documents risk-based approach 8

9 Timing of Validation Activities Key Preparation Standards, Specs, SAT Validation Facility & Utility Qual (IQ/OQ/PQ) Specs, FAT, SAT Equipment Qual (IQ/OQ/PQ) Coverage, Cleaning & Sanitizing Trials Cleaning & Sanitizing Validation Product Specs/Formulae, Instructions, Plant Trials Process & Packaging Validation Full-scale Production 9

10 Classroom Discussion BEST Validation Projects Examples Why? CHALLENGING Validations Examples Why? 10

11 Planning Best Practices Clear path & expectations Team developed & vetted plan History, relationships & expertise Good communication Thorough FAT, SAT, Plant Trials Contingency timing 11

12 Pre-validation Activities & Pre-requisites 12

13 Development Phase Over half of your validation work is spent in the Development phase, before you begin drafting a protocol The #1 Cause of Deviations is insufficient development Equipment Debug / FAT / SAT Process/Clean/Sanit Plant Trials 13

14 Equipment Qualification Pre-requisites Classroom Exercise Facility, Utility & Production Equipment (Critical, SISPPQ) What activities & documents are required to perform a qualification? 14

15 Qualification Development Approved Specification URS, FRS, Scope, Functions, MOCs, Controls Timing, Plan & Resources Identified FAT Executed / Report Materials for SAT/OQ Vendor Documentation Manual(s), MOCs, Spare Parts, Drawing, Preventive Maintenance info, I/Os, Calibration info, etc Align SAT, Routed & Approved (team) Facility Readiness Permits, install personnel, install equipment 15

16 Qualification Pre-requisites Quality Standards Approved Utilities are Installed (Water, Elec, Comp Air, etc) Equipment Delivery Equipment Installation Auxiliary Eqp, Calibration Safety Checklist Equipment Functional & De-bugged IOPQ Drafted, Approved Test Plan, Acceptance Crit Approved SOPs, Training Approved Drawings 16

17 Facility / Utility / Equipment Qualification Checklists 17

18 Cleaning & Sanitizing Validation Pre-requisites Teams 3 minutes Discuss & Present top 3 What activities & documents are required to perform Cleaning & Sanitizing Validation? 18

19 Definitions Cleaning Validation Documented evidence that cleaning process removes product and cleanser to acceptable limits. Sanitizing Validation Documented evidence that sanitizing process reduces microbes to acceptable limits 19

20 Cleaning Validation Development Proposed Product Families & Cleanser(s) Cleanliness Standards MACO, cleanser carryover, visual standard Swab Qualification & Analyte Swab Lab Method Worst-case locations Identified Draft cleaning process & SOP Qualified Equipment CIP/Coverage Tests Cleaning Trial Protocol(s) Team collaborated, approved 20

21 Cleaning Validation Pre-requisites Product for testing Successful Cleaning Trial(s) Approved Product Families Qualified Cleansers (Released) Approved Cleaning SOPs Trained Staff Cleaning Validation Protocol Test Plan, Acceptance Crit Timing, Resources Identified 21

22 Sanitizing Validation Development Proposed Sanitizer(s) Microbial Standards Coliform/Obj.Org./Yeast&Mold Micro Swab Qualification Micro Recovery Lab Method Worst-case locations Identified Draft sanitizing process/sop Clean Equipment (CV) Sanitizing Trial Protocol(s) Team collaborated, approved 22

23 Sanitizing Validation Pre-requisites Successful Sanitizing Trial(s) Qualified Sanitizer(s) Log-reduction, Obj. Organisms Released Chemicals Approved Sanitizing SOPs Trained Staff Sanitizing Val Protocol Test Plan, Acceptance Criteria Timing, Resources Identified 23

24 Cleaning & Sanitizing Validation Checklists 24

25 Process & Packaging Validation Pre-requisites Teams 3 minutes Discuss & Present top 3 What activities & documents are required to perform Process Validation (& Packaging)? 25

26 Definitions Process Validation Documented evidence (scientific evidence) the chemical characteristics of the formula during the production process consistently meets quality requirements (strength, potency, purity, safety) Packaging Validation Evidence the physical aspects of the product meets quality requirements (safety, identity, quality) 26

27 Validation Development Salable Goods! Qualified Equipment, Facility, Utilities Clean & Sanitized Equipment All Manufacturing SOPs Approved & Trained Logs & In-process Tests In Place & Effective Proposed Product Families Analyte Lab Method Draft documents Formula, Product Spec, Raw Spec, Instructions Component Specifications, Instructions Plant Trial Protocol(s) Team collaborated, approved 27

28 Process Validation Pre-requisites Successful Plant Trial(s) Approved Product Documentation Formula(e), Raw & Product Specs, Manufacturing Instructions Standards (Product, Quality) Trained Staff Approved & Released Raw Materials Process Validation Protocol Test Plan, Acceptance Criteria Timing & Resources Identified 28

29 Packaging Validation Pre-requisites Successful Plant Trial(s) Approved Product Documentation Component Specifications, Packaging Instructions Standards (Product, Quality) Approved & Released Components & Bulk Product Packaging Validation Protocol Test Plan, Acceptance Criteria Timing & Resources Identified. And trained staff. 29

30 Process & Packaging Validation Checklists 30

31 Questions? Strategy Development & Pre-requisites 31

32 Planning & Executing Validation Activities 32

33 Considerations Planning Make requirements clear early in a project Use of Project Management Tools Propose Schedule, Resource Plan, Communication Plan, Critical Path Identify & notify departments needed for support, for each validation phase: Develop Draft Execute Deviation Report 33

34 Planning Considerations (con t) Support needed all aspects of execution? Who Draft, Train, sample, test Ensure Availability & transfer of knowledge What are the requirements? Criteria, Sampling, Testing, Results When Our schedule Where Per the defined plan 34

35 Scheduling Resources Establish R&R RACI charts, procedures Identify departments needed for support Plant, Engr, R&D, QA, QC/Lab, Planning Work with departmental management to ensure allocation of resources 35

36 Examples of Management Tools Appropriate for the volume of work Project 4 Levels 1. Individual Level Checklists 2. Detail Level Gantt Chart 3. Team Level 2 Month Forecast 4. High Level Monthly, by type (ie Eqp) 36

37 Management Tool Examples An Established Plant Nashville Plant Validation Tracking Type Description Date Status / Comments Owner Phase IOPQ New Transfer Pump April Spec Issued B Marley 1 Plan IOPQA Motor drive upgrade 13-Apr Drafting, CC approved A Rose 2 Draft IOPQ Filler #4 Done Executed Protocol Review J Lennon 5 Report CV New Transfer Piping June Getting quotes S Davis Jr 1 Plan SV New Sanitizer - Pumps 15-Mar Protocol & comm issued G Brooks 3 Execute SV New Sanitizer - Fillers June Cleaning Trial May 15 R Starr 1 Plan PV New product X Late May Product ships NLT Apr 15 S Dogg 3 Execute PV Upcoming Product August Feasibility D Parton 1 Plan 37

38 Communication Tips Clearly identify activities & responsibility Requirements, Action Items, or Expectations Status & Progress (management) Help people understand why Training, training training! Communication ensures priority Be clear who does what, when. Engage affected groups earlier 38

39 Training Tips Here s what matters to you Make it simple Be clear who does what, when. Protocol/Test training within 24hr Include all those involved Assume they didn t read the protocol Visually demonstrate: what, where, how 39

40 Sample Communication Tools Sampling To: QA, Manufacturing Cc: Project Manager Subject: Upcoming Cleaning Validation: *Title* In case of a failure/issue/questions, stop immediately and call Who Execution When: Target to run late 1 st /early 2 nd shift What to Sample: Active Ingredient Swabs (5), Rinse (3), Sampler: Who? The protocol & sample supplies are located where. Who delivers samples Where, and communicate samples are delivered via /phone to whom Testing When: Should be dropped off 2 nd shift What to Test: Active Ingredient X (5), ph Rinse (3), Communicates results to Who 40

41 Sample Communication Tools Sampling Instructions (print & deliver with samples) Product Name: Protocol #: Validation Contact: Target Run Date: Location # of Samples Qty Required Testing (Lab) Top 1 - N 3 sample jars 500mL Active #1, Active #2, Viscosity Top 2 - S 3 sample jars 500mL Active #1, Active #2, Viscosity Bottom 1 - N 3 sample jars 500mL Active #1, Active #2, Viscosity Bottom 2 - S 3 sample jars 500mL Active #1, Active #2, Viscosity Transfer sample jars 300mL Active #1, Active #2 Transfer sample jars 300mL Active #1, Active #2 Transfer sample jars 300mL Active #1, Active #2 41

42 Execution Tips Try not to schedule too many concurrent validation activities What s the #1 cause of deviation? Ensure processes are well-developed Process/Cleaning/Sanitizing Be clear who is responsible for what Training & Communication 42

43 3 Keys to Success Well-Developed Strategy Don t miss anything Proper Resourcing & Support Validation is executed Communication Properly & Efficiently 43

44 Next Team Exercise Questions? 44

45 Group Exercise OTC manufacturing plant makes suspension drug products. The company has decided to build an expansion for its Blending operation. Team 1 - New Equipment: Three (3) 6,000L Mix Vessels Agitation Turbine, 0-100rpm Team 2 - Daytime Cold & Flu (suspension) Acetaminophen 325mg Guaifenesin 300mg Dextromethorphan HBr 20mg 45

46 Group Exercise Validation Requirements? What development work is needed? High-level schedule: Development, Trial, Protocol, Execution Resource Plan (who, and when) Training & Communication Plan 46

47 Thank you! Justin B. Roose, Head Validation Engineer Product Quality Assurance, Amway Corp Fulton St. East, Ada MI, Bldg 52-2J Biography Justin is a Lead (Head) Validation Engineer at Nutrilite / Amway Corp in Ada, MI. He & his team recently completed validation of a 3-phase supplement production facility. His team is responsible for: equipment & utility qualifications, as well as process, packaging, cleaning, sanitizing and software validation. He also supports a software validation team responsible for 37 corporate software systems used to govern GMP functions in North American Operations. Justin received his BS in Chemical Engineering from Calvin College. He has enjoyed over 18 years of experience across the pharmaceutical, vaccine, biologics, foods and nutritional supplements fields. Since joining Amway Corp in 2006 Justin has created and implemented an effective change control program, led the Validation Department, and created both software & process/packaging validation programs. 47