Nulogy Webinar: How to Run an Audit-Ready Co-Pack Operation

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

events@nulogy.com

1-888-685-6491

www.nulogy.com

James HoughtonPresident, Nova Pack

jhoughton@novapk.com