A Natural Products Association
“Wednesday Webinar”
Making the Grade: Preparing for your
NPA/UL GMP Audit
May 28, 2015
Josh Grauso
Technical Sales Director
UL Registrar
1:00-2:30pm
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NPA
•
Largest and oldest natural products trade group in U.S.
established in 1936
•
Represent more than 2,000 retailers and suppliers of
natural products including:
•
Dietary supplements & ingredients
•
Natural and organic foods
•
Cosmetics, health and beauty aids
NPA
Our Mission
As the leading voice of the natural products
industry, the Natural Products Association's mission
is to advocate for the rights of consumers to have
access to products that will maintain and improve
their health, and for the rights of retailers and
suppliers to sell these products.
Josh Grauso
Technical Sales Director
UL Registrar
As a senior member of UL Registrar’s leadership team, Joshua works with retailers, multi-national
brands, and manufacturing organizations to develop and implement professional 3rd party facility
and/or supplier assessment programs related to industry standards for quality, safety and cGMP
compliance. Joshua is a certified auditor, practitioner, approved training provider and has
performed audits for major retailers and industry recognized certification schemes including cGMP,
ISO9001, OHSAS, 18001, ANSI Z-10, SQF Code, and BRC Global Standards.
Joshua participates on industry technical committees and work groups drafting national and
international standards as a UL Registrar technical representative.
Aides in the strategic planning, development of training presentation tools and materials for
industry specific Seminars. Design and implementation of global supply chain Good
Manufacturing Practices (GMP) Assessment program for the launch of Major retailers FDA
regulated private label brand; major Healthcare Products distributor; and major multi-level
marketing company nutrition, skin-care, and weight management product vendors. Coordinates,
schedule, and conduct of training sessions throughout regions of scope along with the evaluation
of auditors’ progress and performance.
Key assistance in the development and implementation ANSI Accredited ISO Guide 65 SQF
Certification Management System, SQFI Approved Training Center Management System, BRC
Global Standard for Consumer Products Approved Training Provider Program and ANAB
accredited ISO 17020 Inspection Body.
UL Registrar LLC
Making the Grade:
Preparing for GMP Certification Audit
May 28th, 2015
WORKING FOR
A SAFER WORLD
1894
SINCE
THE PRINCIPLES AND VALUES ESTABLISHED BY OUR FOUNDER
DRIVE EVERY DECISION WE MAKE
UL founder William Henry Merrill following 1893 Chicago World’s Fair
7
BUILDING FROM 20 CENTURY SUCCESS
TH
21 CENTURY REALITY
ST
WE ARE A GLOBAL FORCE
FOR GOOD
At UL, our mission of working for a
safer world since 1894 is at the core of
everything we do.
-
Advancing safety through careful research
and investigation
Preventing or reducing loss of life
and property
Promoting safe living and working
environments for all people
10
DELIVERING UNMATCHED EXPERTISE AND THOUGHT
LEADERSHIP
From the adoption of electricity to the
advent of wireless interoperability, UL is the
leading voice for global safety. Our deep
knowledge and expertise make us
invaluable in:
-
Developing standards
Creating codes
Researching safety breakthroughs
Helping customers design, produce,
package and sell safer products
11
WE PROVIDE GLOBAL MARKET
ACCEPTANCE
Our Marks are on nearly 22 billion products
worldwide, per year, signaling peace of
mind to consumers, customers, businesses
and governments.
12
AND HELP YOU NAVIGATE
GLOBAL TRADE
UL helps you navigate:
- Complex country compliance issues
- Regulatory and trade challenges
- Marketplace demands
- Supply chain management
13
THE DEFINITION OF SAFETY IS CONSTANTLY
EVOLVING
Safety is evolving. Complex issues of
today have replaced concerns of the past.
And the safety landscape of tomorrow is
yet to be defined.
- Chemicals
- Dietary Supplements
- Food
- Infrastructure
- Initial adoption of electricity
- Medical devices
- Nanotechnology
- New sustainability breakthroughs
- Renewable energy
- Wireless integration
14
SAFETY IS EVOLVING
SO IS UL
With the definition of safety constantly advancing, UL has
expanded our focus to include an unparalleled breadth of
offerings. Our goal is to better help your business meet the
shifting needs of a changing world.
COMMERCIAL & INDUSTRIAL
CONSUMER
ENVIRONMENT
INFORMATION & INSIGHTS
LIFE & HEALTH
WORKPLACE HEALTH & SAFETY
15
STR - Acquired in 2011
STR is now part of UL Consumer Products
Upholding the purity, potency and trust of dietary supplements
50 years of in-depth testing and validation knowledge for the dietary supplement industry
Recognized for helping clients meet regulatory and consumer demand for high-quality,
safe, and effective products
• Product specification development
• Stability studies
• Sensory evaluation and consumer panels
• Claims substantiation
• Label reviews
• Regulatory consultation
• HACCP programs and audits
• cGMP facility audits
UL already provides dietary supplement testing and audits for 4 of the top 10
retailers and the top 3 drug store chains in North America.
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UL Registrar LLC
UL Registrar is a wholly owned separate legal entity of UL. As a
separate legal entity, UL Registrar protects the impartiality of the audit
and certification process for various industries.
•
•
•
•
•
•
•
Pharmaceuticals
Food & Beverage
Nutritional Supplements
Personal Care Products
Household Chemical Specialties
Medical Devices
Infant Formula
UL Clients (retailers, buyers and manufacturing organizations alike) utilize UL
R Manufacturing Audits and Systems as a means of demonstrating
compliance with due diligence, customer requirements and international
standards of quality, safety and legality.
17
UL R Historic Timeline
2000:
STR-R Joint
Venture Formed
2011:
STR-R Acquired
by UL
STR-R Operated an
ANAB and ANSI Accredited
CB offerings:
• ISO9001
• AS9100
• OHSAS 18001 Health &
Safety
• ANSI Z10 Health & Safety
• SQF Food Safety
Certification
• BRC Consumer Products
• SA8000 Social
Accountability
• Toy Safety Certification
2012:
Name change to
UL Registrar LLC
UL Registrar LLC becomes
ACLASS Accredited Inspection
Body for:
• OTC Drugs GMP
• Dietary Supplements GMP
• API/Ingredient GMP
• Cosmetics/Personal Care GMP
• Medical Devices GMP
• Food GMP
• HACCP
• General Consumer
Merchandise GMP
2013:
UL Registrar LLC divests
Management System
business
Under the UL and DQS
Agreement, UL Registrar LLC
is required to transfer
Management System
Certification business to DQS
in July 2013 including:
• ISO 9001
• AS9100
• OHSAS18001
• ANSI Z10
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UL Registrar - Overview
•
UL Registrar offers third-party, independent manufacturing/process assessments
against a defined standard.
UL Registrar
Audit
Certify
Train
Minimize Supply Chain Risk
Protect Brand Value
Promote Quality, Product Safety, Legality
•
Our Mission:
•
To be the global leader in advancing sustainable business practices within the supply
chains worldwide.
UL Registrar Accreditations
UL Registrar’s Core Accredited/Approved/Licensed Programs operate
globally across multiple industries including:
• Good Manufacturing Practices (GMP)
• ACLASS Accredited National Brand Certification Programs (NBCP).
• ACLASS Accredited Retail Certification Programs (RCP).
• Safe Quality Food (SQF) Certification
• British Retail Consortium (BRC) Certification
• SA8000 Certification
Approved Consumer Product
Audit Body
Approved Training Provider
Approved Implementers
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The Retail Certification Program (RCP)
•
The Retail Certification Program (RCP) is an ACLASS Accredited, annual Good
Manufacturing Practices (GMP) Assessment, which satisfies multiple retailers’ yearly
audit requirements, as well as promotes conformance to the United States Food and
Drug Administration (FDA) Requirements.
•
The RCP Program satisfies multiple retailer requirements with a single audit.
Therefore, RCP offers these benefits…
Gain
Reduce
Accredited Certificate
Audit Cost
Increased Confidence
Audit Frequency
Audit Fatigue
Audit Redundancy
The Retail Certification Program (RCP)
Retailers need to…
Suppliers/Facilities…
Accept
Is/are the Client
Support
Recognition for RCP Audits
(directly or indirectly)
Sends results to Retailer
Important Notes:
• Registrar has multiple retailers “on board” with the program. This
means that the Retailer will accept a supplier’s RCP Deliverable.
• The Supply Chain is the target of RCP, but without the Retailer
acceptance, the program would not be successful.
• Example: If a factory has 1 GMP audit for Walmart, 1 GMP audit
for Target, and 1 GMP audit for Publix each year, all 3 of these
retailers will accept 1 RCP report, which reduces the 3 audits to 1.
The Retail Certification Program (RCP)
Target
Walmart
Many Retailers
Support
The Retail
Certification
Program.
Walgreens*
Dollar General/Family Dollar
(either directly or
indirectly*)
BJ’s
Publix
The Six System Approach to Quality
The audits are conducted utilizing the
Quality System Approach per the
FDA’s Compliance Program Guidance
Manual: Drug Manufacturing,
Inspections Program 7356.002.
Audit Conclusions are drawn through
- review of policies & procedures,
- physical observations,
- interview of operators and
technicians,
- verification of existing records.
Production
Packaging
Materials
The Quality
System
Laboratory
Facilities &
Equipment
RCP Details
Globally, UL Registrar conducts GMP Certification Audits across
multiple scopes, product groups, and industries.
Medical Devices
Pharmaceuticals
Cosmetics/
Personal Care
FDA
Non-Regulated
Products
Nutritional
Supplements
Food and Infant
Formula*
Plus many more.
*Not all scopes are accepted by all retailers/brands
Accredited Technical Scope
Standards
Salient points
•
•
•
21 CFR 111
NPA GMP Standard for Dietary Supplements
FDA Compliance Program Guidance Manual: Drug
Manufacturing Inspections Program 7356.02 and
applicable, related, approved FDA guidance documents
Production, Facilities & Equipment, Material & Vendor Management,
Packaging, Laboratory and Quality Systems utilized to manufacture,
package and store/hold FDA regulated products
– Nutritional (Dietary) Supplements
•
•
21 CFR 210/211
FDA Compliance Program Guidance Manual: Drug
Manufacturing Inspections Program 7356.02 and
applicable, related, approved FDA guidance documents
Production, Facilities & Equipment, Material & Vendor Management,
Packaging, Laboratory and Quality Systems utilized to manufacture,
package and store/hold FDA regulated products
– Over-The-Counter Drugs
•
•
FDA’s Cosmetic GMP Guidance
ISO 22716:2007 Cosmetic Good Manufacturing
Guidelines
FDA Compliance Program Guidance Manual: Drug
Manufacturing Inspections Program 7356.002 and
applicable, related, approved FDA guidance documents
Production, Facilities & Equipment, Material & Vendor Management,
Packaging, Laboratory and Quality Systems utilized to manufacture,
package and store/hold FDA regulated products
– Cosmetics/Personal Care
•
•
•
21 CFR 110
FDA Compliance Program Guidance Manual: Drug
Manufacturing Inspections Program 7356.02 and
applicable, related, approved FDA guidance documents
Production, Facilities & Equipment, Material & Vendor Management,
Packaging, Laboratory and Quality Systems utilized to manufacture,
package and store/hold FDA regulated products
– Food
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Accredited Technical Scope
Standard
•
•
•
•
•
•
Salient points
ICH Q7A Guidance for Industry
NSF/IPEC/ANSI 363 Excipient GMP
EXCiPACT GMP and GDP Certification Standard for
Pharmaceutical Excipients
FDA Compliance Program Guidance Manual: Drug
Manufacturing Inspections Program 7356.02 and
applicable, related, approved FDA guidance
documents
Production, Facilities & Equipment, Material & Vendor
Management, Packaging, Laboratory and Quality Systems utilized
to manufacture, package and store/hold FDA regulated products
– OTC Drug API/Excipient/Component
– Dietary Ingredients
21 CFR 110, 106 & 107
FDA Compliance Program Guidance Manual: Drug
Manufacturing Inspections Program 7356.02 and
applicable, related, approved FDA guidance
documents
Production, Facilities & Equipment, Material & Vendor
Management, Packaging, Laboratory and Quality Systems
utilized to manufacture, package and store/hold FDA regulated
products
– Infant Formula
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Certification Process
Pre-Audit:
Application and Scope
Agreement
Initial Audit:
Review of SOP, Interview of
Employee, Review of Records,
Physical Observations.
Nonconformities identified and
CAPA Issued.
Post Audit:
Root Cause and CAPA
submitted by Supplier.
Reviewed offsite by ULR. In
cases of severe
Nonconformance (“Major”)
Onsite Follow Up Audit
Required.
Once All CAPAs are accepted,
Certification is awarded. If
CAPAs are not acceptable,
Certification is denied.
Annual Audit required thereafter
to maintain Certification
following identical CAPA and
review process as well as
expanded Scope Assessments
due to product, process or
physical changes.
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Nonconformity Defined
Critical Non-conformance
Major Non-conformance
Minor Non-conformance
A deficiency that judgment and experience indicate would result in hazardous
or unsafe conditions for individuals using, maintaining, or depending on a
product; a deficiency that judgement and experience indicate is likely to result
in product recall due to economic fraud, or a deficiency that could result in the
distribution of a product that is contaminated and/or toxic, or constitutes a risk
to human health.
A systemic failure of any system, procedure or process or failure to comply with
required regulations (are than a failure defined as a Critical) that would have
significant impact on the quality, strength, identity, or purity of the product or
the lack of a system, process or procedure required by regulations.
An Isolated witnessed incident of failure to adhere to an approved policy,
procedure, instruction or process, where:
• There is insufficient evidence to be classified as a Critical or Major;
• There is little potential for significant impact to the customer/user;
• The quality of the product/service has not been compromised.
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CAPA Process
Nonconformities to the Audit
Standard are defined and
documented uniquely on ULR
CAPA Forms and provided to
Auditee
Auditee is provided 30 calendar
days to Provide:
-Root Cause Analysis
-Corrective/Preventive Action Plan
-Responsibility
-Timeline
Once All CAPAs are accepted,
Certification is awarded. If CAPAs
are not acceptable, Certification is
denied.
2 Annual Surveillance Audits
required thereafter to maintain
Certification following identical
CAPA and review process as well
as expanded Scope Assessments
due to product, process or
physical changes.
All Major and Critical
Nonconformities Require Onsite
Follow up within 90 Days to verify
Effective Implementation of CAPA
Plan
Recertification Audit is then
planned prior to Certificate
Expiration and a renewed
certification is issued.
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Audit Duration
The duration of the Audit is dependent on the number of employees that are
working on a given site, the size and extent of operation. “Auditor-days”, noted
below, are defined as one (1) auditor onsite for eight (8) hours. Thus, a 1.5auditor-day audit would require one (1) auditor to be onsite for 1.5 days.
Certified Entity Number of
Employees
Auditor-Days for
Initial Audit
Surveillance
Audit-Days
1-500
2
1
501-999
3
2
1,000
4
3
Additive Factors include:
• Logistics: More than 1 building
• High Risk Products/Processes
• Language: requires use of
interpreter
• Very Large Site (Sq footage)
• Degree of Regulation
• Highly Complex/Multiple
Processes
• Seasonal Requirements
Subtractive Factors include:
• Scope Exclusions
• Low Risk Products/Processes
• Extremely Small Site
• Combined Audit or integrated
system of Management Systems
• Prior Knowledge
• Low Complexity/Single Process
31
Accreditation to ISO/IEC 17020 provides UL
Registrar, LLC and our clients with an industry first
accredited assessment program. To attain and
maintain ANAB Accreditation, ULR is audited
annually based on designed and implemented
controls and systems for:
•
•
•
•
•
•
•
•
•
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Independence, Impartiality, & Integrity
Confidentiality
Organization & Management
Quality System
Personnel Competency
Facilities & Equipment Inspection Methods & Procedures
Record Control
Inspection Reports & Certificates
Complaints & Appeals
Industry Cooperation
32
Why
Accreditation?
•
Retailers and manufacturers
benefit from knowing that their
GMP audits of quality systems
and supplier facilities meet
international guidelines, are
conducted by experts with
specific understanding of their
products, and have been
vetted by the world’s leading
authority on standardization
and quality.
•
ANAB provides accreditation
to ISO/IEC 17020 for
inspection bodies and is part
of the American National
Standards Institute (ANSI).
33
Once Certified:
As a benefit of this program the client is awarded the use of certificates including marks,
badges and seals to demonstrate their achievement. Each certified client will receive
permission for use of the following marks, symbols, badges and seals subject to certain
rules.
UL Enhanced Certification Mark
ACLASS Accreditation
Symbol
UL Certification Badge
NPA GMP Seal
34
UL Enhanced Certification Mark:
Each certified client will receive permission for use of the following marks, badges and
seals subject to the following rules:
UL Enhanced Certification Mark
•
The UL Enhanced Certification Mark may be used ONLY on the Certificate of
Conformity issued to your organization by UL.
•
•
The UL Enhanced Certification Mark shall not be used on any product.
The UL Enhanced Certification Mark shall not be used in advertising or promotional
materials.
Note: The Certificate of Conformity may be reproduced as permitted above, but the UL
Enhanced Certification Mark alone shall not be reproduced in any manner, hard copy or
electronically.
•
35
UL Certification Badge :
Each certified client will receive permission for use of the following marks, badges and
seals subject to the following rules:
UL Certification Badge
•
•
•
•
•
The UL Certification Badge is designed to promote and advertise your UL
Certifications, providing an attractive way to share this information with the marketplace.
UL Certification Badges may appear on a range of materials, from brochures, web
content, marketing collaterals, etc. The UL Enhanced Certification Mark shall not be
used on any product.
UL Certification Badges cannot appear larger than the organization’s name on any
promotional materials.
Text on UL Certification Badges must accurately reflect the scope of UL Certification.
This UL Certification Badge shall be used only in association with a UL Certified
Management System. If a Management System is no longer certified by UL, the UL
Certification Badge must be removed or promotional materials destroyed.
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ACLASS Accredited Inspection Body Symbol:
Each certified client will receive permission for use of the following marks, badges and
seals subject to the following rules:
ACLASS Accreditation
Symbol
•
•
•
•
•
To assist ACLASS accredited certification bodies and their audited and inspected certified clients in the
use of the ACLASS symbol, a company certified by UL Registrar LLC may use the ACLASS symbol.
The ACLASS symbol may be used on a company’s literature, including but not limited to: letter headings,
business cards, brochures, advertising, website and marketing materials.
Regardless of where used, the ACLASS symbol MUST ALWAYS BE USED IN CONJUNCTION WITH
THE UL CERTIFICATION BADGE – THE ACLASS SYMBOL MUST NEVER BE ALLOWED TO BE
USED IN ISOLATION.
The ACLASS symbol may be used by an organization with UL Management System Certification only
under the name in which it holds certification (i.e. the name listed on the UL Certificate of Conformity).
If non-scoped products that are not included on the UL Certificate of Conformity are included on a
website or other advertising media where the ACLASS Symbol and UL Certification Badge are being
displayed, a footnote/statement must acknowledge which product and/or product type and/or referenced
CFR and/or product group, etc. is not within the scope of the management system certification
37
Once Certified:
Each certified client will receive permission for use of the following marks, badges and
seals subject to the following rules:
NPA GMP Seal
NPA GMP Seal
The rules for the use of NPA GMP Seal is still under development. In general the following
will apply:
• The NPA GMP Seal is designed to promote and advertise your Certification, providing
an attractive way to share this information with the marketplace.
• NPA GMP Seal may appear on a range of materials, from brochures, web content,
marketing collaterals, etc.
• For an additional fee, NPA will grant the use of the NPA GMP Seal on products to further
promote the GMP Certification status of the facility producing the product bearing the
NPA GMP Seal.
38
How does my new NPA/UL GMP Certification Audit fit in
with UL’s Clearview Approach?
GMP Audit
Responsible
Sourcing
Verify Content
No Harmful 
Substances
Training
Verification
Program
Content & Formulation Storage 
Data Management 
Test Method Documentation 
Information
Management
Testing
Registration
Program
 GMP requirements
 Content
 Physical
 Sensory
 Contaminants
 Formula registration
 On Going Testing
39
Clearview Service Levels
Can be customized to meet specific needs
UL Registration
Formula Registration and Initial Content Testing
Compliance to disposal and transportation requirements
Annual Content Testing and Data Visibility
General Specification Review
(Optional) Upload of Audit Compliance Data and Visibility
UL Qualification
Registration
Upload of Current Audit Compliance Data
Bi-Annual Surveillance Testing
UL Verification
Qualification
Label Review
UL Retail Certification Program Audit
Production Lot Testing Review
40
Visibility and Assurance
• Information Management of Quality Assurance Data
• Equips retailers and brand owners with visibility into suppliers’ quality
assurance activities to make more informed buying decisions
• Allows suppliers to differentiate themselves
41
UL is Uniquely Positioned to Help
Through strategic acquisitions, UL has brought together the three assets
necessary to enable dietary supplements customers to manage their complex
supply chains and make smarter decisions.
A trusted consumer brand with
heritage and equity in safety
science
A testing, validation, and
audit services provider
with a deep understanding
of the dietary supplement
market
A recognized supply chain
data management solutions
platform
42
THANK YOU.
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For more information, please contact
Scientific & Regulatory Affairs Manager
Joy Akins at jakins@NPAinfo.org
Save the Date! Save the Date!
June 17th
GMO Mythbusters II
GMOs are still the hottest topic in the industry. NPA has invited Jeffrey Smith, executive director of
Institute for Responsible Technology (IRT) an advocate promoting healthier non-GMO choices, to speak
on this topic. He will present his insight on the safety and science behind GMOs to allow you to make an
informed opinion on GMOs. Learn the latest about lawsuits pertaining to products containing GMO
ingredients. Some states have passed legislation on GMO labeling, what are the trigger provisions for
your state’s GMO labeling legislation? Keith Matthews, partner at Sidley Austin LLP, will cover legal
challenges surrounding voluntary labeling as non-GMO, state legislation, and looking at GMOs from a
legal view.
June 25th
SQF Certification
Through the NPA/UL partnership, NPA is now able to offer SQF Certification to members. Find out what the
Safe Qualify Food Certification is and how you can receive the certification. UL is licensed by the Safe Quality
Food Institute (SQFI) and will give you an introduction to the globally recognized GFSI Code intended to
promote food safety and quality management system conformance. SQF audits aide an organization
minimize risk and gain consumer’s trust in an organization's food brand.
Save the Date! Save the Date!
Emergency Web Conference
Revised New Dietary Ingredient Guidance
Within 72 hours of FDA’s publication of the re-draft of the NDI Guidance, which could
occur at any time between now and the end of the year, NPA will hold a Web conference
highlighting the most important and pressing aspects of the guidance and its regulatory and
scientific impact. Featured speakers include: Dr. Daniel Fabricant, Scott Bass, William
McConagha, and Dr. Corey Hilmas.
To register, look for the announcement in your inbox soon.
To continue receiving notifications from NPA please
add natural@NPAinfo.org to your email contacts
Thank You!
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