nulogy webinar: how to run an audit-ready co-pack operation
TRANSCRIPT
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Presented by: James Houghton, Nova Pack
How to Run an Audit-Ready Co-Pack Operation
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James HoughtonPresident, Nova Pack
Daisy JiangContent Marketing Manager,
Nulogy
Who We Are
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Material Control
Physical Space
Paper-work
People
(Occupants)(Framing) (Corridors)(Foundation)
Get Your House in Order
Produc-tion
(Rooms)
QA OVERSIGHT THROUGH IT ALL
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1. Secondary/tertiary co-packer
2. Business view of Quality
3. Centers around GMP (covers ISO, AIB, SQS)
Background & Disclaimer
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PEOPLE (foundation)
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People
Culture1
• What type do you want?
• What type do you have?
• How do you shift?
• Can’t just say it – have to live it.
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Building a team & reporting structure
People
Culture1
2
• Right person for the right job
• Personality fit, compatibility, accurate job descriptions
• Key players – sponsorship, autonomy, consistency
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Building a team & reporting structure
Training & education
People
Culture
3
• Structure/matrix
• Timing, documentation, and records management
• PPE
2
1
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Building a team & reporting structure
People
Culture
2
4 External presentation
• Client & vendor interaction
3
2
1
Training & education
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PAPERWORK (framing)
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Paperwork
SOP1
• Auditor will look for both content & consistency
• It’s not rocket science; write out what you do, and follow it
• 2 reasons you could fail
Activity does not fulfill requirements
SOP-Activity mismatch
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Business end
Paperwork
SOP
2
• Contract: not for specific piece of work, but more statement of relationship
• RFQ Quote PO SOW
1
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Business end
Batch record
Paperwork
SOP
2
3• “Set” = a template approach
• Actual work fills in the blanks on a template
• Logical flow/consistency
1
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Business end
Batch record
Change control & retention
Paperwork
SOP
3
4
• Document historical activity and changes to your site
• Maintain those documents for “x” period
2
1
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Business end
Batch record
Change control & retention
Paperwork
SOP
4
5 GDP
• Good Documentation Practices
3
2
1
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PHYSICAL SPACE (corridors)
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Physical Space
Flow1
• Minimal interruptions
• Delineated – differentiate & segregate (RM / WIP / FG)
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Housekeeping
Physical Space
Flow
2
• Plan
• Document
• Consistency
1
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Housekeeping
Sanitation
Physical Space
Flow
2
3
• Equipment (tie into batch record)
• People (tie into training)
2
1
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Housekeeping
Sanitation
Physical Space
Flow
4 Other considerations
• Pest control, construction, fixtures, signage, etc
22
1
3
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MATERIAL CONTROL (rooms)
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Identification1
Material Control
• Everything in you building should have identification on it
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Receiving inspection
Material Control
Identification
2
1
• When, what, if compliant, matched, moved
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Receiving inspection
Track & traceability
Material Control
Identification
3
2
1
• Ability to find• “Show me you know where
everything is” • FIFO• Lot assignment
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Receiving inspection
Track & traceability
Storage
Material Control
Identification
4
3
2
1
• Clearly identified • Off floor • Segregation • Consider allergens• Temperature & humidity
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Material Control
Reconciliation
• What you got • What you used• What’s damaged• What’s left• Unaccounted for discrepancies
5
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Stewardship
Material Control
Reconciliation
6
5
• Tie into culture• Who owns it?• Insurance
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Stewardship
Shipping inspection
Material Control
Reconciliation
7
5
6
• Packed up properly • Trucks ok • Sending the right stuff/quantity/time
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PRODUCTION (occupants)
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Line clearance1
Production
• Set-up properly • Equipment/hand tools• Material insurance to line• Segregation • Staff allotment
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Samples / approval
Production
Line clearance
2
1
• Who does it?• From where?• Workmanship standard
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Samples / approval
Job-specific knowledge
Production
Line clearance
3
22
1
• Staff• Training• Sign-off/documentation
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Samples / approval
Job-specific knowledge
Production
Line clearance
Equipment4
22
1
3
• Arrangement, calibration, sanitation, preventative maintenance
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Production
In-process inspection5
• Who?• How?• How often? (AQL)• Documentation
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Discrepancies
Production
In-process inspection
6
5
• How to handle• Documentation• Sign-off
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Discrepancies
Finished goods inspection
Production
In-process inspection
7
26
5
• Who?• How?• Documentation
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QA Oversight (Roof)
There must be QA oversight through it all.
• How is your QA organized and rallied?
• How does your Batch Record Review look?
• What kind of Quality Management System do you have?
Production
People
PaperworkPhysical Space
MaterialControl
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10 Commandments of GMP
Thou shalt follow thy written procedures
Thou shalt document thy work
Thou shalt validate thy work
Thou shalt write procedures1
Thou shalt be competent as a result of education, training & experience
Thou shalt be clean
Thou shalt build in quality, not test quality into thy product
Thou shalt maintain thy facilities & equipment
Thou shalt audit for complianceThou shalt design & build proper facilities & equipment
2
3
4
5
6
7
8
9
10
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Q&A SESSION
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Contact Us
@nulogy
facebook.com/Nulogy
1-888-685-6491
www.nulogy.com
James HoughtonPresident, Nova Pack