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VALIDATION  THEORY AND APPLICATION Presented by: Mrs. Remedios A. Rivera Telstar Mfg. Plant Sta. Rosa, Laguna March 12 & 16, 2009
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
VALIDATION ACTIVITIES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],HISTORY OF VALIDATION
[object Object],[object Object]
[object Object]
C. All necessary facilities are provided including ,[object Object],[object Object],[object Object],b) Adequate  premises and space; c) Suitable  equipment and services; d) Correct  materials, containers, and labels
APPROVED! e)  approved procedures and instructions; d) Suitable storage and transport; and f) Adequate personnel laboratories, and equipment for in-process controls
[object Object],[object Object]
[object Object]
[object Object]
[object Object]
[object Object]
[object Object]
TEN COMMANDMENTS OF GMP Thou shalt document (record) thy work! Thou shalt validate thy work!  Thou shalt design and build proper facilities and equipment! Thou shalt maintain thy facilities and requirement! Thou shalt be competent (as a result of education training  and experience)! Thou shalt be clean! Thou shalt control for quality! Thou shalt audit for compliance!
VALIDATION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
Proving Sufficient replication of the testing and challenging of each defined critical Stage of a system, process, etc. that has to be performed to give valid levels of assurance KEY FEATURES:
Documenting An adequate  System of referenced documentation  is essential.
[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
“ Document everything ” To Play It Safe “ If there is any question, play it safe.  Document everything and document it thoroughly.” - James Harris, PHD (Director of Sterile  Operations, Merck and  Chairman, Computer  Systems Validation  Committee, Pharmaceutical  Manufacturers  Ass.) in “The  Gold Sheet”, V19, No. 1,  Jan.1985.
Work done, but not recorded in writing, for the purpose of  validation is considered as never  having been performed. ,[object Object],[object Object],[object Object],[object Object],DOCUMENTED FOCUS
SYNONYMS       ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],Safety
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],REDUCTION  OF  QUALITY  COSTS
[object Object],[object Object],[object Object],Regulatory Compliance
Assurance of Quality ,[object Object],[object Object],[object Object],[object Object],[object Object]
Process Optimization Optimum batch size Reduced  processing  time Decreased downtimes Reduce new  facility/ process start-up time    
BENEFITS OF VALIDATION ,[object Object],[object Object]
[object Object]
[object Object]
[object Object]
[object Object],[object Object]
[object Object]
-  for presentation in case of an inspection - as legal proof of safety in a  product liability  case - as a document for a  marketing authorization application and a  certification The validation documentation can be used:
[object Object],[object Object],- capture the market  with  better quality product at a lower price
[object Object],[object Object],WHAT TO VALIDATE? ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],Operating  Procedure
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],IF YOU DO NOT KNOW,  DO NOT VALIDATE, JUST INVESTIGATE
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],WHEN TO REVALIDATE
  1. Gen. Manager  2. Plant Manager    3. Project Manager  4. QA Manager    5. GMP Manager  6. Production Manager    7. Validation Manager  8. Engineering Manager ,[object Object],[object Object],xx xx xx xx xx xx Accepting xx xx Reporting x Testing xx xx xx xx xx Xx Validation X x x x x xx Project Xx xx Authorization x x x x x xx xx xx Strategy 8 7 6 5 4 3 2 1
Strategy Team Authorization Team Project Team Validation Team Investigation Team (S) Evaluation Team (S) Acceptance Team (S) TEAM FUNCTION/ROLES TEAM FUNCTION APPROACH (Multidisciplinary Team Members)
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
Contents Introduction Objective (s) Justification Approach Scope Acceptance Support  Programs Validation Team Organization Schedules Appendix VALIDATION MASTER PLAN
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],Is there a specified format for a VALIDATION MASTER PLAN?
[object Object],[object Object],[object Object]
[object Object],[object Object],What are the contents of a VALIDATION MASTER PLAN?
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
Site Services (SSVP) Electrical Power (SSVP001) Meralco Generator Sewage Plant (SSVP-002) Water (SSVP-003) Potable Hot Softened Chlorination (SSVP-005) Air Conditioning (SSVP-005) Equipment Filters Cooling coils Heating coils Fan Dehumidifies Condensing units Cooling Towers Building Manufacturing Site (BUP) Construction & Layout  (BVP-001 Structure & finish  (BVP-002) General Floor & walls Ceiling Doors & windows Drainage (BVP-003) Utilities/ System (SUP) HVAC (SVP-001) Lighting (SVP-002) Electrical/safety Vacuum (SVP-003 Dust Collection  (SVP-004) Water (SVP-005) Potable Purified Steam (SVP-006) Compressed  Air  (SVP-007 Equipment (EVP) Mixer (EVP-001) Blender (EVP-002) Filler  (EVP-003 ) Compressor  (EVP-004 ) Processes Product  Listing VALIDATION FAMILY TREE
[object Object],- - x Building x x x Air Conditioning x x x Chlorination x x x Water x x x Sewage Plant x x x Electrical Power Site Services PQ OQ IQ
x - - Processes x x x Equipment x x x Dust Collection x x x Compressed Air x x x Steam x x x Water x x x Vacuum x x x Lighting/Electrical x x x HVAC Utilities/System
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],VALIDATION PROTOCOL
A formal monitoring system by which qualified representatives from appropriate disciplines, review proposed or actual changes that, might affect validated status and define and authorize appropriate action to be taken that will assure the facilities and operations retain their validated state of control VALIDATION CHANGE CONTROL
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],DESIGN QUALIFICATION (DQ) A typical DQ document includes these basic information:
[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],Specification Responsible Supplier This is how we will build it Design Specification Supplier This is what we could give you Functional Requirements Specification User This is what we want User Requirements Specifications
Validation V-Model Is based on Is based on Is based on PQ OQ IQ User  Specification Functional Specification Design  Specification Implementation D E S I G N Q U A L I F I C A T I O N
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
TEST FAILURES ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object]
BEFORE QC + IPC = PRODUCT QUALITY
NOW PV + QC + IPC = ASSURED PRODUCT QUALITY
RESTROSPECTIVE VALIDATION 12% 13% 17% 8% 16% 9% 25% FEATURES Marketed products Use  HISTORICAL DATA Use of  SPECIFIC  PROCESS
WHEN TO DO RETROSPECTIVE VALIDATION ONLY IF WITHIN a reasonable period of time; Sufficient number of batches O  are produced in adequate facility O are produced without change in procedure O are produced without technical difficulties 31 30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 SAT FRI THU WED TUE MON SUN
[object Object],[object Object]
If validated analytical methods have demonstrated that the final product is in Conformity with the specification for all Quality Characteristics
GOOD FOLLOW UP STABILITY RESULTS
Products not previously validated Stable manufacturing history (20 batches, if available) Product to be sold or discontinued Are changes Significant? Is timing a consideration Accumulate 20 batches Candidate for Retrospective validation (yes) (no) (yes) (no) (yes) (no) Low priority validation Selection of candidate for retrospective validation
[object Object],[object Object],[object Object],New product Modified product Use of New equipment Use of New Process COVERAGE
PROSPECTIVE  VALIDATION ACTIVITIES ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
EQUIPMENT VALIDATION
[object Object],[object Object],[object Object]
How do we qualify equipment? ,[object Object],[object Object],[object Object]
[object Object],[object Object]
[object Object]
[object Object]
CALIBRATION ,[object Object],Federation International Pharmaceutique, 1990.
[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Testing Monitoring or Measuring Control
What are the requirements of a fully documented calibrated system? ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
What are the requirements of a fully documented calibration system? ,[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What are the requirements of a fully documented calibration system? ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BUILDING VALIDATION
BUILDING VALIDATION ,[object Object],[object Object],[object Object],[object Object]
Objective: To document that the building was  constructed according to the approved lay-out & plan (Reference: Roombook) BVP-001 Subject Construction & Layout Building Validation Protocol Approved by/Date: Reviewed by/Date: Prepared by/Date: Page ___of _ Review Date: Date of issue: Copies to:
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Building Validation Construction & layout (BVP-001) Checklist ,[object Object],Inspected by: Date: Verified by: Date                 10                 9                 8                 7                 6                 5                 4                 3                 2    √  √  √  √  √  √   √ 1 Remarks Fire Sensor Air Return Air Supply Window Switches Door Size Room
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],BVP-002 Subject STRUCTURE & FINISH Building Validation Protocol Approved by/Date: Reviewed by/Date: Prepared by/Date: Page ___of _ Review Date: Date of issue: Copies to:
Building Validation (BVP-002) Checklist Put (√) for conforming and (X) for non-conforming Room No./ID             - Coved joints with wall                     - Sloped towards floor drains (1/8 inc/foot             - Not affected by cleaning materials                         - Smooth, Non porous  free from cracks, crevices 6 5 4 3 2 1 A. FLOOR
Room No./ID             - ducting sealed at the point of entry         - not affected by cleaning agents         - utilities with sloped tops (45º)             - coved joint with ceiling             cracks, crevices             - smooth, Non porous free from 6 5 4 3 2 1 B. WALLS
Room No./ID             the ceiling must be sealed             ,[object Object],[object Object],        -  free from cracks             -  smooth, easy to clean             deterioration             -  Free from flaking and other visible 6 5 4 3 2 1 C. CEILINGS
Room No./ID             - door kick plates beveled or flat             - must have automatic  closer         - opening clearance of maximum 3.0mm                         - frames flush with the surrounding walls             - smooth, hard, close tightly 6 5 4 3 2 1 D. DOORS
Room No./ID             - flush with the surrounding walls             - tightly sealed not permitted to open             - smooth, hard  6 5 4 3 2 1 E. WINDOWS
Room No./ID Inspected by: Date: Verified by: Date:             prevent back flow.             -  with air break or other mechanical device to             - with cover & easy to clean             - trapped gulleys and properly ventilated             - adequate size 6 5 4 3 2 1 F. DRAINAGE
[object Object],[object Object],Page of___of____ Date of issue: Reference: Operations Approved by/Date Checked by/Date: Prepared by/Date: EVP-001 Subject : Minoga Emulsifying Mixing Machine AS-500As Equipment Validation Protocol Copies to:
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
[object Object],[object Object],[object Object],3 Layer a) Inner SUS 316 b) Middle SUS 304 c) Outer SUS 304 1.2 Tank 500 As 1.1 Model Not Acceptable Acceptable As Found As Designed
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],1.4 Tank Lid 650 L 1.3 Tank Capacity Not  Acceptable Acceptable As Found As Designed
Sensor 1.9 Temperature Control 5 HP vacuum pump with safety device (water type) 1.8 Vacuum  Part 2HP Hydraulic Motor 1.7 Lid Rising 5HP variable speed 12.6-63 rpm with inverter 1.6 Scrapping  Mixer 7.5 HP Variable speed (540-3600 rpm) with inverter 1.5  Emulsifying  mixer  Not  Acceptable Acceptable As Found As Designed
60 w 220v, 60 HZ 3 phase 1.14 Light 1.15 Power 1 set 1.13 Control  Box ,[object Object],[object Object],[object Object],1.12 Product discharge Jacket 1.11 Cooling System 1.10 Heating  System  Not  Acceptable Acceptable As Found As Designed
2. Installation Verification 2.2 Power Connection *voltage/power stability (±10% ) * grounded connection * no electrical leakage * correct voltage (220V) 2.1 Location * stable & even * good drainage system * base & frame properly fixed not ok ok
2.8 Training Done 2.7 Maintenance SOP 2.6 Cleaning SOP 2.5 Motor Direction * Scrapping Motor * Emulsifying Motor * Hydraulic Motor * Vacuum Motor 2.4 Circulation water * piping acceptable 2.3 Power Indicator * will switch on not ok ok
3. Operational Qualification 3.6 Hydraulic Part * lid can go up & down 3.5  Vacuum pump * vacuum is achieved &  maintained 3.4 Scrapping Mixer * speed adjustment 3.3 Emulsifier * Speed adjustment 3.2 Discharging * can be tilted * bottom valve discharge  3.1 Material charging port * lid can be opened * material sucked by vacuum not ok ok
3.11 Safety Devices * limit switches functioning * over loading protection * vacuum safety device * emergency stop functioning * alarm device functioning * level sensor functioning 3.10 Light Injection * Functioning 3.9 Temperature Control * Controller records * Temperature Sensor by Thermocouple 3.8 Cooling System * functioning 3.7 Steam Heating Not ok ok
PROCESS VALIDATION
Objective: To demonstrate that the processing of baby Lotion using  Minoga Emulsifying Mixer will produce consistently product  meeting specification Page of__of___ Effectivity Date: Issue Date: Approved by/Date: Checked by/Date: Prepared by/Date: PVP-001 Subject Baby Lotion W1 RD-048 Process Validation  Protocol Copies to: Reference
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],      No fish eyes Carbopol Dissolution       1200 rpm Mixer Speed       75ºC Water Temperature No Yes       Parameters Met? Measured Required  
[object Object],      30 rpm Mixer Speed       To be established Vacuum No Yes       Parameters Met? Measured Required  
[object Object],[object Object],      300 rpm Mixer Speed       75-80ºC Temperature No Yes       Parameters Met? Measured Required  
[object Object],[object Object],      35-40 rpm Mixing Speed       record Vacuum Reading       75-80ºC Oil Phase       75-80ºC Water Phase No Yes       Parameters Met? Measured Required  
[object Object],[object Object],      record Initial Viscosity       record pH       30-40 rpm Mixer Speed       75-80ºC Temperature No Yes       Parameters Met? Measured Required  
5.3.2 Addition of Sodium Hydroxide       35-40 ºC Mixer Speed       record Viscosity       record pH       record Temperature       record Volume Added No Yes       Parameters Met? Measured Required  
[object Object],      To be established Viscosity       35-40 rpm Mixer Speed       45ºC Temperature No Yes       Parameters Met? Measured Required  
[object Object],      NLT 10,000 cps Viscosity       35-40 rpm Mixer Speed       30-35ºC Temperature No Yes       Parameters Met? Measured Required  
[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
BABY LOTION (PVP-001) Checklist ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],current not current yes no yes yes yes yes no no no no
[object Object],Conclusion       No fish eyes Carbopol Dissolution       1,200 rpm Mixer Speed       75ºC Water Temperature No Yes       Parameters Met? Measured Required  
[object Object],Conclusion       300 rpm Mixer Speed       To be established Vacuum No Yes       Parameters Met? Measured Required  
5.2.1 Oil Phase       300 rpm Mixer Speed       75-80ºC Temperature No Yes       Parameters Met? Measured Required  
5.3 Emulsification       35-40 rpm Mixing speed       75-80ºC Oil Phase Temperature       75-80ºC Water Temperature No Yes       Parameters Met? Measured Required   To be established Vacuum setting
5.3.1 Viscosity Adjustment   After 20 minutes mixing       record Initial Viscosity       record pH       35-40 rpm Mixer speed       75-80ºC Temperature No Yes       Parameters Met? Measured Required  
5.3.2 After adding sodium hydroxide       35-40 rpm Mixer Speed       record Viscosity       record pH       record Temperature       record Volume Added No Yes       Parameters Met? Measured Required  
5.3.3 Force Cooling       record Viscosity       35-40 rpm Mixer Speed       45ºC Temperature No Yes       Parameters Met? Measured Required  
5.3.5  Final Cooling       NLT 10,000 cps Viscosity       35-40 rpm Mixer Speed       30-35ºC Temperature No Yes       Parameters Met? Measured Required  
5.3.6  Final Analysis       Negative Yeasts and Molds       NLT 10,000 cps Viscosity       LT 100,000 cfu/gm Total Aerobic Microbe       0.95-1.00 Specific gravity       5.5 - 7.5 pH       white Color       Emulsion Appearance Bottom Middle Top Required  
[object Object],[object Object],[object Object],[object Object],[object Object]
HVAC VALIDATION
Types of HVAC & Applications Class 100,000 /D Class 10,000 /C Class 100/B Class 100/A + + + + + + + + + +
Comparison of the Different Classification System D ISO8 100,000 M 6.5 D C ISO7 10,000 M 5.5 C B ISO5 100 M 3.5 B A ISO5 100 M 3.5 A GMP 14644 209E Customary Annex 1/GMP WHO ISO US US PIC/S
USER REQUIREMENT SPECIFICATION (HVAC) ,[object Object],[object Object],   
[object Object]
[object Object],HVAC system
[object Object]
[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],HVAC system
[object Object],[object Object]
Objective: To verify that heating, Ventilating  and Air Conditioning system will  produce air of acceptable standards  and quality Page___of ____ Date of Issue Review Date Approved by/Date: Checked by/Date: Prepared by/Date: SVP-001 Subject:  HVAC System System Validation  Protocol Copies to
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
HVAC System (SVP-001) Checklist ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Attached Not Attached Identified Not Identified Identified Not Identified
3. Filtration System Conclusion conforms not conforming AHU 2 C 5 Airlock AHU 2 C 4 Compounding AHU 2 C 3 Filling AHU 1 UC 2 External Corridor AHU 1 UC 1 Washing AHU No Classification Room ID Room As Per Design
Air Handling Filtration System Filtration system Should be as  specified below Conclusion conforms not conforming Water Cooled AHU 1&2 90-95% Disposable 80-85% Disposable 25-30% Washable Efficiency Type  of Filter Efficiency Type  of Filter Efficiency Type  of Filter Final Filter Secondary Primary
5. Fan Coil Unit Filtration System   The FCU filtration system should    be as follows Conclusion conforms not conforming Filtration System 90-95% Disposable 80-85% Disposable 25-30% Washable Efficiency Type  of Filter Efficiency Type  of Filter Efficiency Type  of Filter Final Filter Secondary Primary
6. Functional Specification 6.2 Pressure Differential & Air Flow Pattern 6.1.1 Final Filter downstream of the  blowing fan (to blow air through the system) 6.1.2 With pressure differential device No Yes 6.1 Filtration System 6.2.1 Airflow must be mfg to filling room, Filling room to corridor Filling room to next room 6.2.2 Pressure should be 5-9 pascals from  room to corridor
6.6 Dust Extractor System - installed as per design drawing 6.5 Duct work - free from asbestos - low pressure type - clean & sealed - pressure tested - Flexible duct NMT 2  meters - flushed for 12 hours  before installation of filters 6.4 Air changes specified per room 6.3 Operating room condition  controlled
9.0 Documentation Available 8.0 Maintenance & Calibration of HVAC  available 7.0  Critical Instrument Calibrated? 6.8 Monitoring System Functioning and in suitable location 6.7 External Environment Protection Solids – negative pressure room Liquids – positive pressure vs corridor
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2. HVAC specification VS  order conforms 1. Room built as per design No Yes B. Installation Qualification
5. Verification of Installed Components 5.1 air handling unit 5.2 30% pre-filter 5.3 65% pre-filter 5.4 pre-cooling coil 5.5 cooling coil 5.6 supply air fan 5.7 supply air fan motor 5.8 95% filter 4. Availability of Engineering Documents - commissioning report - manufacturer’s manual - full parts list - spare parts list - lubricant list - maintenance schedule - as built drawing
[object Object],[object Object]
[object Object],[object Object],[object Object],YES NO CORRECTED
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],Conclusion:             10             9             8             7             6             5             4             3             2             1 No Yes Air Change Air Change Volume Volume   Accepted Calculated Minimum Supply Air  Room  Room  No.
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Room Pressure (Solids) Conclusion:       12.5 pascals 6 (Filling)       12.5 pascals 5 (Mfg)       12.5 pascals 4 (Gowning)       12.5 pascals 3 (Dispensing)       25.0 pascals 2 (Office)       12.5 pascals 1 (Weighing) No Yes Pressure Pressure   Accepted Measured Design Room No.
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
Conclusion:             Joints               Mounting               Periphery               Face 2             Joints               Mounting               Periphery               Face 1 No Yes             Accept Allowable Penetration Actual Penetration Down Stream Penetration  (Design) Uptream  Concentration  ug/L Type  of  Test Scan Room  No.
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Conclusion:         7         6       25 º C  ±  0.5  º C 5       25 º C  ±  0.5  º C 4       22 º C  ±  0.5  º C 3       21 º C  ±  0.5  º C 2       21 º C  ±  0.5  º C 1 No Yes Measured Room  Temp Expected Temp     Accept   Temperature Room  No.
[object Object],[object Object],[object Object],[object Object],available Not available available Not available
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Validation Theory And Application 3

  • 1. VALIDATION THEORY AND APPLICATION Presented by: Mrs. Remedios A. Rivera Telstar Mfg. Plant Sta. Rosa, Laguna March 12 & 16, 2009
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10. APPROVED! e) approved procedures and instructions; d) Suitable storage and transport; and f) Adequate personnel laboratories, and equipment for in-process controls
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17. TEN COMMANDMENTS OF GMP Thou shalt document (record) thy work! Thou shalt validate thy work! Thou shalt design and build proper facilities and equipment! Thou shalt maintain thy facilities and requirement! Thou shalt be competent (as a result of education training and experience)! Thou shalt be clean! Thou shalt control for quality! Thou shalt audit for compliance!
  • 18.
  • 19.
  • 20. Proving Sufficient replication of the testing and challenging of each defined critical Stage of a system, process, etc. that has to be performed to give valid levels of assurance KEY FEATURES:
  • 21. Documenting An adequate System of referenced documentation is essential.
  • 22.
  • 23.
  • 24.
  • 25. “ Document everything ” To Play It Safe “ If there is any question, play it safe. Document everything and document it thoroughly.” - James Harris, PHD (Director of Sterile Operations, Merck and Chairman, Computer Systems Validation Committee, Pharmaceutical Manufacturers Ass.) in “The Gold Sheet”, V19, No. 1, Jan.1985.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32. Process Optimization Optimum batch size Reduced processing time Decreased downtimes Reduce new facility/ process start-up time    
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 39. - for presentation in case of an inspection - as legal proof of safety in a product liability case - as a document for a marketing authorization application and a certification The validation documentation can be used:
  • 40.
  • 41.
  • 42.
  • 43.
  • 44.
  • 45.
  • 46.
  • 47.
  • 48.
  • 49.
  • 50.
  • 51.
  • 52.
  • 53.
  • 54.
  • 55. Strategy Team Authorization Team Project Team Validation Team Investigation Team (S) Evaluation Team (S) Acceptance Team (S) TEAM FUNCTION/ROLES TEAM FUNCTION APPROACH (Multidisciplinary Team Members)
  • 56.
  • 57.
  • 58.
  • 59.
  • 60.
  • 61. Contents Introduction Objective (s) Justification Approach Scope Acceptance Support Programs Validation Team Organization Schedules Appendix VALIDATION MASTER PLAN
  • 62.
  • 63.
  • 64.
  • 65.
  • 66.
  • 67.
  • 68.
  • 69.
  • 70. Site Services (SSVP) Electrical Power (SSVP001) Meralco Generator Sewage Plant (SSVP-002) Water (SSVP-003) Potable Hot Softened Chlorination (SSVP-005) Air Conditioning (SSVP-005) Equipment Filters Cooling coils Heating coils Fan Dehumidifies Condensing units Cooling Towers Building Manufacturing Site (BUP) Construction & Layout (BVP-001 Structure & finish (BVP-002) General Floor & walls Ceiling Doors & windows Drainage (BVP-003) Utilities/ System (SUP) HVAC (SVP-001) Lighting (SVP-002) Electrical/safety Vacuum (SVP-003 Dust Collection (SVP-004) Water (SVP-005) Potable Purified Steam (SVP-006) Compressed Air (SVP-007 Equipment (EVP) Mixer (EVP-001) Blender (EVP-002) Filler (EVP-003 ) Compressor (EVP-004 ) Processes Product Listing VALIDATION FAMILY TREE
  • 71.
  • 72. x - - Processes x x x Equipment x x x Dust Collection x x x Compressed Air x x x Steam x x x Water x x x Vacuum x x x Lighting/Electrical x x x HVAC Utilities/System
  • 73.
  • 74.
  • 75. A formal monitoring system by which qualified representatives from appropriate disciplines, review proposed or actual changes that, might affect validated status and define and authorize appropriate action to be taken that will assure the facilities and operations retain their validated state of control VALIDATION CHANGE CONTROL
  • 76.
  • 77.
  • 78.
  • 79.
  • 80.
  • 81. Validation V-Model Is based on Is based on Is based on PQ OQ IQ User Specification Functional Specification Design Specification Implementation D E S I G N Q U A L I F I C A T I O N
  • 82.
  • 83.
  • 84.
  • 85.
  • 86.
  • 87.
  • 88.
  • 89.
  • 90.
  • 91.
  • 92.
  • 93.
  • 94.
  • 95.
  • 96.
  • 97.
  • 98.
  • 99.
  • 100.
  • 101.
  • 102.
  • 103. BEFORE QC + IPC = PRODUCT QUALITY
  • 104. NOW PV + QC + IPC = ASSURED PRODUCT QUALITY
  • 105. RESTROSPECTIVE VALIDATION 12% 13% 17% 8% 16% 9% 25% FEATURES Marketed products Use HISTORICAL DATA Use of SPECIFIC PROCESS
  • 106. WHEN TO DO RETROSPECTIVE VALIDATION ONLY IF WITHIN a reasonable period of time; Sufficient number of batches O are produced in adequate facility O are produced without change in procedure O are produced without technical difficulties 31 30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 SAT FRI THU WED TUE MON SUN
  • 107.
  • 108. If validated analytical methods have demonstrated that the final product is in Conformity with the specification for all Quality Characteristics
  • 109. GOOD FOLLOW UP STABILITY RESULTS
  • 110. Products not previously validated Stable manufacturing history (20 batches, if available) Product to be sold or discontinued Are changes Significant? Is timing a consideration Accumulate 20 batches Candidate for Retrospective validation (yes) (no) (yes) (no) (yes) (no) Low priority validation Selection of candidate for retrospective validation
  • 111.
  • 112.
  • 113.
  • 114.
  • 116.
  • 117.
  • 118.
  • 119.
  • 120.
  • 121.
  • 122.
  • 123.
  • 124.
  • 125.
  • 126.
  • 127.
  • 128.
  • 129.
  • 131.
  • 132. Objective: To document that the building was constructed according to the approved lay-out & plan (Reference: Roombook) BVP-001 Subject Construction & Layout Building Validation Protocol Approved by/Date: Reviewed by/Date: Prepared by/Date: Page ___of _ Review Date: Date of issue: Copies to:
  • 133.
  • 134.
  • 135.
  • 136. Building Validation (BVP-002) Checklist Put (√) for conforming and (X) for non-conforming Room No./ID             - Coved joints with wall                     - Sloped towards floor drains (1/8 inc/foot             - Not affected by cleaning materials                         - Smooth, Non porous free from cracks, crevices 6 5 4 3 2 1 A. FLOOR
  • 137. Room No./ID             - ducting sealed at the point of entry         - not affected by cleaning agents         - utilities with sloped tops (45º)             - coved joint with ceiling             cracks, crevices             - smooth, Non porous free from 6 5 4 3 2 1 B. WALLS
  • 138.
  • 139. Room No./ID             - door kick plates beveled or flat             - must have automatic closer         - opening clearance of maximum 3.0mm                         - frames flush with the surrounding walls             - smooth, hard, close tightly 6 5 4 3 2 1 D. DOORS
  • 140. Room No./ID             - flush with the surrounding walls             - tightly sealed not permitted to open             - smooth, hard 6 5 4 3 2 1 E. WINDOWS
  • 141. Room No./ID Inspected by: Date: Verified by: Date:             prevent back flow.             - with air break or other mechanical device to             - with cover & easy to clean             - trapped gulleys and properly ventilated             - adequate size 6 5 4 3 2 1 F. DRAINAGE
  • 142.
  • 143.
  • 144.
  • 145.
  • 146.
  • 147.
  • 148.
  • 149.
  • 150. Sensor 1.9 Temperature Control 5 HP vacuum pump with safety device (water type) 1.8 Vacuum Part 2HP Hydraulic Motor 1.7 Lid Rising 5HP variable speed 12.6-63 rpm with inverter 1.6 Scrapping Mixer 7.5 HP Variable speed (540-3600 rpm) with inverter 1.5 Emulsifying mixer Not Acceptable Acceptable As Found As Designed
  • 151.
  • 152. 2. Installation Verification 2.2 Power Connection *voltage/power stability (±10% ) * grounded connection * no electrical leakage * correct voltage (220V) 2.1 Location * stable & even * good drainage system * base & frame properly fixed not ok ok
  • 153. 2.8 Training Done 2.7 Maintenance SOP 2.6 Cleaning SOP 2.5 Motor Direction * Scrapping Motor * Emulsifying Motor * Hydraulic Motor * Vacuum Motor 2.4 Circulation water * piping acceptable 2.3 Power Indicator * will switch on not ok ok
  • 154. 3. Operational Qualification 3.6 Hydraulic Part * lid can go up & down 3.5 Vacuum pump * vacuum is achieved & maintained 3.4 Scrapping Mixer * speed adjustment 3.3 Emulsifier * Speed adjustment 3.2 Discharging * can be tilted * bottom valve discharge 3.1 Material charging port * lid can be opened * material sucked by vacuum not ok ok
  • 155. 3.11 Safety Devices * limit switches functioning * over loading protection * vacuum safety device * emergency stop functioning * alarm device functioning * level sensor functioning 3.10 Light Injection * Functioning 3.9 Temperature Control * Controller records * Temperature Sensor by Thermocouple 3.8 Cooling System * functioning 3.7 Steam Heating Not ok ok
  • 157. Objective: To demonstrate that the processing of baby Lotion using Minoga Emulsifying Mixer will produce consistently product meeting specification Page of__of___ Effectivity Date: Issue Date: Approved by/Date: Checked by/Date: Prepared by/Date: PVP-001 Subject Baby Lotion W1 RD-048 Process Validation Protocol Copies to: Reference
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  • 166. 5.3.2 Addition of Sodium Hydroxide       35-40 ºC Mixer Speed       record Viscosity       record pH       record Temperature       record Volume Added No Yes       Parameters Met? Measured Required  
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  • 174. 5.2.1 Oil Phase       300 rpm Mixer Speed       75-80ºC Temperature No Yes       Parameters Met? Measured Required  
  • 175. 5.3 Emulsification       35-40 rpm Mixing speed       75-80ºC Oil Phase Temperature       75-80ºC Water Temperature No Yes       Parameters Met? Measured Required   To be established Vacuum setting
  • 176. 5.3.1 Viscosity Adjustment After 20 minutes mixing       record Initial Viscosity       record pH       35-40 rpm Mixer speed       75-80ºC Temperature No Yes       Parameters Met? Measured Required  
  • 177. 5.3.2 After adding sodium hydroxide       35-40 rpm Mixer Speed       record Viscosity       record pH       record Temperature       record Volume Added No Yes       Parameters Met? Measured Required  
  • 178. 5.3.3 Force Cooling       record Viscosity       35-40 rpm Mixer Speed       45ºC Temperature No Yes       Parameters Met? Measured Required  
  • 179. 5.3.5 Final Cooling       NLT 10,000 cps Viscosity       35-40 rpm Mixer Speed       30-35ºC Temperature No Yes       Parameters Met? Measured Required  
  • 180. 5.3.6 Final Analysis       Negative Yeasts and Molds       NLT 10,000 cps Viscosity       LT 100,000 cfu/gm Total Aerobic Microbe       0.95-1.00 Specific gravity       5.5 - 7.5 pH       white Color       Emulsion Appearance Bottom Middle Top Required  
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  • 183. Types of HVAC & Applications Class 100,000 /D Class 10,000 /C Class 100/B Class 100/A + + + + + + + + + +
  • 184. Comparison of the Different Classification System D ISO8 100,000 M 6.5 D C ISO7 10,000 M 5.5 C B ISO5 100 M 3.5 B A ISO5 100 M 3.5 A GMP 14644 209E Customary Annex 1/GMP WHO ISO US US PIC/S
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  • 193. Objective: To verify that heating, Ventilating and Air Conditioning system will produce air of acceptable standards and quality Page___of ____ Date of Issue Review Date Approved by/Date: Checked by/Date: Prepared by/Date: SVP-001 Subject: HVAC System System Validation Protocol Copies to
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  • 203. 3. Filtration System Conclusion conforms not conforming AHU 2 C 5 Airlock AHU 2 C 4 Compounding AHU 2 C 3 Filling AHU 1 UC 2 External Corridor AHU 1 UC 1 Washing AHU No Classification Room ID Room As Per Design
  • 204. Air Handling Filtration System Filtration system Should be as specified below Conclusion conforms not conforming Water Cooled AHU 1&2 90-95% Disposable 80-85% Disposable 25-30% Washable Efficiency Type of Filter Efficiency Type of Filter Efficiency Type of Filter Final Filter Secondary Primary
  • 205. 5. Fan Coil Unit Filtration System The FCU filtration system should be as follows Conclusion conforms not conforming Filtration System 90-95% Disposable 80-85% Disposable 25-30% Washable Efficiency Type of Filter Efficiency Type of Filter Efficiency Type of Filter Final Filter Secondary Primary
  • 206. 6. Functional Specification 6.2 Pressure Differential & Air Flow Pattern 6.1.1 Final Filter downstream of the blowing fan (to blow air through the system) 6.1.2 With pressure differential device No Yes 6.1 Filtration System 6.2.1 Airflow must be mfg to filling room, Filling room to corridor Filling room to next room 6.2.2 Pressure should be 5-9 pascals from room to corridor
  • 207. 6.6 Dust Extractor System - installed as per design drawing 6.5 Duct work - free from asbestos - low pressure type - clean & sealed - pressure tested - Flexible duct NMT 2 meters - flushed for 12 hours before installation of filters 6.4 Air changes specified per room 6.3 Operating room condition controlled
  • 208. 9.0 Documentation Available 8.0 Maintenance & Calibration of HVAC available 7.0 Critical Instrument Calibrated? 6.8 Monitoring System Functioning and in suitable location 6.7 External Environment Protection Solids – negative pressure room Liquids – positive pressure vs corridor
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  • 210. 5. Verification of Installed Components 5.1 air handling unit 5.2 30% pre-filter 5.3 65% pre-filter 5.4 pre-cooling coil 5.5 cooling coil 5.6 supply air fan 5.7 supply air fan motor 5.8 95% filter 4. Availability of Engineering Documents - commissioning report - manufacturer’s manual - full parts list - spare parts list - lubricant list - maintenance schedule - as built drawing
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  • 218. Room Pressure (Solids) Conclusion:       12.5 pascals 6 (Filling)       12.5 pascals 5 (Mfg)       12.5 pascals 4 (Gowning)       12.5 pascals 3 (Dispensing)       25.0 pascals 2 (Office)       12.5 pascals 1 (Weighing) No Yes Pressure Pressure   Accepted Measured Design Room No.
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  • 222. Conclusion:             Joints               Mounting               Periphery               Face 2             Joints               Mounting               Periphery               Face 1 No Yes             Accept Allowable Penetration Actual Penetration Down Stream Penetration (Design) Uptream Concentration ug/L Type of Test Scan Room No.
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  • 225. Conclusion:         7         6       25 º C ± 0.5 º C 5       25 º C ± 0.5 º C 4       22 º C ± 0.5 º C 3       21 º C ± 0.5 º C 2       21 º C ± 0.5 º C 1 No Yes Measured Room Temp Expected Temp     Accept   Temperature Room No.
  • 226.
  • 227. Have A Nice Day