NSF International

The Public Health and Safety Company

Nutraceuticals, Functional Foods and Dietary
Supplements
2
nd
International Conference
24/7 GMP Compliance and Readiness

Topics to be Covered
Who and What is NSF
What are the purpose of GMPs
Common areas of non-compliance of GMPs
Questions
Who is NSF International?
The global leader in Dietary Supplement and Ingredient
Certification and GMP Registrations
Developer over 60 national consensus standards
Steadfast ties with key associations and government agencies,
such as U.S. FDA and Health Canada
A Collaborating Centre for the World Health Organization
Our Mission has always focused on
Protection of Public Health and Safety
NSF International, an
independent, not-for-profit
non-governmental
organization, is dedicated
to being the leading global
provider of public health
and safety-based risk
management solutions
while serving the interests
of all stakeholders.
Our core purpose is to protect and improve human health.
We are Uniquely Positioned to Objectively
Coordinate Stakeholder Interests
Health Canada, US FDA,
NIH, ODS
Dietary Supplements,
Food, Water, Air
Media, Educators,
Consumer Groups
Consumers
Regulators
Industry
What are Good Manufacturing Practices
Certifications that NOT GMP programs
There are a number of quality systems and
certifications available but they do not define or meet
GMP requirements.
ISO 9000
HAACP
Organic Certification
Halal Certification
Kosher Certified
GFSI: BRC, SQF, Global Gap, ISO 22000
What are GMPs?
Good Manufacturing Practices establish the minimum
necessary activities related to manufacturing,
packaging, labeling, or holding dietary supplements
to ensure the efficacy, quality purity and safety of the
dietary supplement
The fundamental principle behind GMPs is that you
cannot test quality into a finished product, you have
to build it in the manufacturing process.
Who does GMP apply to?
GMP regulations effects companies that
manufacturer, package, label or hold dietary
supplements, and requires qualification and
monitoring of a companys supply chain
In the United States, for example, GMP regulations
apply to all dietary supplements sold and marketed
in the United States, even those made outside of
the United States, including India.
Manufacturing Quality is determined by
GMP Compliance
Everything that takes place in the manufacturing
process effects product quality.
Including
Raw Material Qualification
Preventative Maintenance
Employee Actions
Documentation
Cleaning
Testing
And Quality is Related to Profitability
Regulator Finds Customer Finds
Manufacturer Finds Manufacturer Prevents
Dietary Supplement Specific GMPs
Similar areas of Food vs. Supplement GMPs
Pest Control
Trash Disposal
Water Supply
Sanitation Supervision and Management
Maintenance of Plant and Grounds
Cleaning procedures
Documentation management
Similar areas of Pharma vs. Supplement GMPs
Testing of Incoming Materials
Setting of Product and Ingredient Specifications
Laboratory Records
Master Manufacturing Records
Sample Retention
Personnel training
Common Areas for Non-Compliance
Testing of incoming raw materials
Every incoming dietary ingredient must be tested
Component specifications must be set to ensure purity,
strength and composition are engineered into a product.
All incoming ingredients must be subjected to identity testing,
and verification that the incoming raw material meets the
specifications as set by the manufacturer.
Certificate of Analysiss may be used from a supplier if the
manufacturer has qualified the supplier, through auditing and
testing. It is the manufacturers responsibility to ensure
adequate controls are met to ensure identity, purity and
quality of raw materials.
Qualification of Suppliers & C of As
How did you qualify the supplier? Raw materials,
packaging, and components?
What parameters and testing data are used to
support the reliance of the data on the C of A?
Have you or an accredited third party audited your
supplier for GMP compliance?
Does your program go far enough: testing,
auditing, and frequency?
Contamination
GMPs do not establish upper limits for microbial
contamination
GMPs do not set levels for heavy metal contamination in this
regulation for dietary supplements.
It is the responsibility of the manufacturer to identify
contaminants and establish limits as to prevent adulteration
For example, in the U.S. irradiation is no longer allowed in
addressing microbial loads. If irradiation is used, a company
must file a food additive petition to FDA , and make the claim
on the products label.
Batch Records
Do your batch records provide for traceability of the
raw materials, components and labels used as well
as equipment used in production
Make sure you have proper sign-offs at each step
of the process
Document cleaning and sanitation of equipment
How to handle reprocessing, if necessary?
Paperwork, Documentation and SOPs
A solid GMP system is a document intensive
regulation, that is focused toward process controls,
SOPs and record keeping
Solid SOPs are fundamental in creating a
repeatability and engineering a consistent product
from batch to batch
SOPs should be representative of the activities
taking place at the facility
If it is not documented, it doesnt exist!!!
Preventing contamination
Does your facility have proper metal detection as
part of the manufacturing process?
Backflow systems on all hose connections
Hands free faucet controls
Proper usage or hair restraints, gloves, lab coats
and foot covers
Conclusions and Takeaways
Perform an internal GAP analysis of where your programs
may have shortcomings and need to be strengthened
All of your staff must be trained in GMP compliance and
understand their roles and responsibilities
Make sure your paperwork is fully thought through and
documented, especially for batch records and testing
Full GMP compliance will take time, effort and investment.
Develop a budget and plan to help ensure your company is
on track for compliance
NSF GMP Program
Good Manufacturing Practices
(NSF/ANSI Standard 173, Section8)
Objective of GMPs:
GMPs provide specific standards for the
manufacturing, packaging, warehousing and
distribution of dietary supplements
Audit to verify that process is working properly
Testing to assuring quality: Testing of raw
materials to finished product
All requirements for the GMP audit are outlined in
Section 8 of the American National Standard
NSF/ANSI 173 for Dietary Supplements
GMP Registration Program
Section 8 of NSF 173
Annual full GMP audits (2-3 days)
Annual follow-up monitoring audits (1day)
A facility will become NSF Registered and listed
on our website when they meet all of the
requirements of the NSF GMP program as
outlined in Section 8 of NSF/ANSI Standard 173.
Questions
Edward Wyszumiala
Dietary Supplement and Functional Food Programs
General Manager
ewyszumial@nsf.org
(734) 913-5706
Ann Arbor, MI