nulogy webinar: how to run an audit-ready co-pack operation
TRANSCRIPT
Presented by: James Houghton, Nova Pack
How to Run an Audit-Ready Co-Pack Operation
James HoughtonPresident, Nova Pack
Daisy JiangContent Marketing Manager,
Nulogy
Who We Are
Material Control
Physical Space
Paper-work
People
(Occupants)(Framing) (Corridors)(Foundation)
Get Your House in Order
Produc-tion
(Rooms)
QA OVERSIGHT THROUGH IT ALL
1. Secondary/tertiary co-packer
2. Business view of Quality
3. Centers around GMP (covers ISO, AIB, SQS)
Background & Disclaimer
PEOPLE (foundation)
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.
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
Building a team & reporting structure
Training & education
People
Culture
3
• Structure/matrix
• Timing, documentation, and records management
• PPE
2
1
Building a team & reporting structure
People
Culture
2
4 External presentation
• Client & vendor interaction
3
2
1
Training & education
PAPERWORK (framing)
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
Business end
Paperwork
SOP
2
• Contract: not for specific piece of work, but more statement of relationship
• RFQ Quote PO SOW
1
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
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
Business end
Batch record
Change control & retention
Paperwork
SOP
4
5 GDP
• Good Documentation Practices
3
2
1
PHYSICAL SPACE (corridors)
Physical Space
Flow1
• Minimal interruptions
• Delineated – differentiate & segregate (RM / WIP / FG)
Housekeeping
Physical Space
Flow
2
• Plan
• Document
• Consistency
1
Housekeeping
Sanitation
Physical Space
Flow
2
3
• Equipment (tie into batch record)
• People (tie into training)
2
1
Housekeeping
Sanitation
Physical Space
Flow
4 Other considerations
• Pest control, construction, fixtures, signage, etc
22
1
3
MATERIAL CONTROL (rooms)
Identification1
Material Control
• Everything in you building should have identification on it
Receiving inspection
Material Control
Identification
2
1
• When, what, if compliant, matched, moved
Receiving inspection
Track & traceability
Material Control
Identification
3
2
1
• Ability to find• “Show me you know where
everything is” • FIFO• Lot assignment
Receiving inspection
Track & traceability
Storage
Material Control
Identification
4
3
2
1
• Clearly identified • Off floor • Segregation • Consider allergens• Temperature & humidity
Material Control
Reconciliation
• What you got • What you used• What’s damaged• What’s left• Unaccounted for discrepancies
5
Stewardship
Material Control
Reconciliation
6
5
• Tie into culture• Who owns it?• Insurance
Stewardship
Shipping inspection
Material Control
Reconciliation
7
5
6
• Packed up properly • Trucks ok • Sending the right stuff/quantity/time
PRODUCTION (occupants)
Line clearance1
Production
• Set-up properly • Equipment/hand tools• Material insurance to line• Segregation • Staff allotment
Samples / approval
Production
Line clearance
2
1
• Who does it?• From where?• Workmanship standard
Samples / approval
Job-specific knowledge
Production
Line clearance
3
22
1
• Staff• Training• Sign-off/documentation
Samples / approval
Job-specific knowledge
Production
Line clearance
Equipment4
22
1
3
• Arrangement, calibration, sanitation, preventative maintenance
Production
In-process inspection5
• Who?• How?• How often? (AQL)• Documentation
Discrepancies
Production
In-process inspection
6
5
• How to handle• Documentation• Sign-off
Discrepancies
Finished goods inspection
Production
In-process inspection
7
26
5
• Who?• How?• Documentation
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
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
Q&A SESSION
Contact Us
@nulogy
facebook.com/Nulogy
1-888-685-6491
www.nulogy.com
James HoughtonPresident, Nova Pack