NSF INTERNATIONAL | 1
NSF INTERNATIONAL789 N. Dixboro Road, Ann Arbor, Michigan 48105 USA
alicephoto/123RFGraphic elements sourced from 123RF.com
A GLOBAL LEADER INPUBLIC HEALTH & SAFETY
Dietary Supplement Manufacturing: Common Missteps and What it Takes to Ensure Consumer Safety
NSF INTERNATIONAL | 2
Agenda NSF International Overview
NSF Dietary Supplements Program
GMP Registration Program
GMP Audits
Common Dietary Supplement Industry Missteps & Compliance
NSF INTERNATIONAL | 3
OUR MISSION
NSF International is dedicated to being the leadingglobal provider of public health and safety-based risk management solutions while serving the interests of all stakeholders, namely the public, the business community and government agencies.
NSF International is a global, independent public health and safety organization.
Our mission and focus has always beenprotecting and improving human health.
NSF INTERNATIONAL | 4NSF INTERNATIONAL | 4AN INTRODUCTION
NSF AROUNDTHE GLOBE
NSF provides services in
175+ countrieswith 61 office and
laboratory locations.
NSF INTERNATIONAL | 5NSF INTERNATIONAL | 5AN INTRODUCTION
NSF INTERNATIONALACCREDITATIONS AND CERTIFICATIONS
Canada Europe ISO 14001
ISO 17025
United States China
NSF INTERNATIONAL | 6
NSF CERTIFIED PRODUCTS
614,000
SERVICES & CAPABILITIES
CERTIFIED PRODUCTSAND COUNTING
NSF INTERNATIONAL | 7NSF INTERNATIONAL | 7FDA Overview
Dietary Supplements Manufacturing Landscape
>15,000+ FDA registered dietary supplement manufacturing facilities
• Over half are located outside the U.S.
> Approximately 4% dietary supplement facilities were inspected by the FDA for compliance
> FDA estimates that there are 55-80k DS products in the US
>26 total full time employees at FDA DS dept.
NSF INTERNATIONAL | 11
NSF-Ann Arbor Testing Capabilities
NSF-Ann Arbor Supports DS testing utilizing several unique laboratories and instruments
> Microbiology• Contaminant testing for Yeast and Mold, Salmonella, E-Coli, Staphylococcus• Probiotic Strain and activity Label Claim Verification
> Metals• Contaminant testing for Heavy Metals (Arsenic, Cadmium e.g.)• Mineral Label Claim Verification ( Calcium, Sodium, Potassium)
> HPTLC• Label Claim Verification by Qualitative Identification of Botanical ingredients
> HPLC• Label Claim Verification by Qualitative and Quantitative measurement of DS ingredients
> GC• Label Claim Verification by Qualitative and Quantitative measurement of DS ingredients
> LCMS/GCMS• Athletic Banned Substance testing by Semi-Quantitative Screening
NSF INTERNATIONAL | 13NSF INTERNATIONAL | 13
Certified for Sport® Program> The product is manufactured at a facility that
is GMP registered and audited twice annually for quality and safety by NSF International to comply with the U.S. FDA’s Good Manufacturing Practice (GMP) requirements.
> The contents of the supplement actually match what is printed on the label; verification of label claims and formulas.
> There are no unsafe levels of contaminants, toxins, heavy metals or fraudulent ingredients in the tested products.
> Products are tested for more than 272+ substances banned by major athletic organizations and anti-doping agencies.
NSF INTERNATIONAL | 15NSF INTERNATIONAL | 15
What are cGMPs?: Current Good Manufacturing Practices> Food & Drug Administration (FDA) Regulations provides guidance on how to
manufacture quality and safe products across various classifications of products (food, dietary supplements, pharmaceutical, medical devices, etc.) to protect the consumer.
> cGMPs are the LAW for all consumer product manufacturers, it is not optional.
> Applicable to all products manufactured, imported and distributed in the USA.
NSF INTERNATIONAL | 16NSF INTERNATIONAL | 16
Dietary Supplements Product Regulations> 21 CFR Part 110
• cGMP in Manufacturing, Packing or Holding Human Food
> 21 CFR Part 111• cGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements
> 21 CFR Part 117• cGMP, Hazard Analysis and Risk-Based Preventive Controls for Human Food
> Food Safety Modernization Act (FSMA) 2011
> Dietary Supplement Health & Education Act (DSHEA) 1994
16
NSF INTERNATIONAL | 17NSF INTERNATIONAL | 17
Scope of Dietary Supplements GMPs Regulations
Dietary Ingredients
Excipients
Dietary SupplementsDistribution
Dietary Supplements Manufacturer
Dietary Supplements Storage
CONTRACTDietary Supplements
Mnfg. / Pkg.
Dietary Supplements Packaging
Across the Supply Chain
Across the Supply Chain
Brand Owner
NSF INTERNATIONAL | 18NSF INTERNATIONAL | 18
NSF GMP Audit Lifecycle
Facility Audit Technical ReviewCorrective Action Response Process
Monitoring Audit
DRAFT GMP Facility Audit Report
GMP Facility Audit
Report
• Calibration• Severity• Accuracy
NSF INTERNATIONAL | 19NSF INTERNATIONAL | 19
GMPs Emphasize 5 Working Practices
Personal Hygiene
High degree of personal cleanliness
Handwashing
Prevention of contamination by employee illness’
Clean outer garments worn or uniform, cap and proper use of face masks, safety shoes, etc.
No watch and jewelry.
Keep the Order
Warehouses clean and tidy.
Critical and non critical process areas, in order and clean.
Avoid misuse of packaging.
Absence of pests (insects, rodents, etc.).
No contaminating agents.
Operations
Walls, windows, ceilings, floors and signs in good condition
Process flow in a manor to prevent cross contamination.
Master Batch Record / Batch Production Record up to date.
Specifications available across the Supply Chain (DI, packaging,
in-process, FP, etc.)
Identity, composition, strength and purity are validated.
Proper storage conditions
Cleaning
General cleaning without standing water.
Correctly use of soap and sanitizer.
Equipment not in use, clean and protected.
Drains and gutters clean and in good condition.
Appropriate cleaning materials, clean and tidy.
Cleaning must be validated and verified.
Security
Site Security, electronic, natural disasters, etc.
Avoid unsafe acts.
Reduce unsafe conditions.
Proper use of personal protective equipment.
Work with safe tools and equipment.
NSF INTERNATIONAL | 20
Pre-rinse Cleaning Sanitizing Inspection
Cleaning and Sanitation Process
• All equipment in a food or beverage production facility should have a cleaning and maintenance schedule.
• Frequency of cleaning should be as often as necessary to prevent the accumulation of soil.
Involves the removal of any soil such as dirt, cobwebs, grease, product debris and prevention of accumulation of residues.
HIGH RISK MEDIUM RISK LOW RISK
ManagementResponsibilities
Corrective and Preventative Action (CAPA)
Sample Retention Program
Personnel Training Complaint Management Visitor’s Policy
Crisis Management Internal Audit Program Site Overview
Product ID & Traceability Document Controls
Product Recall Regulatory Inspection
Control of Non-Conforming Product
Food Defense & Security
Site Vendor Assessment Management Program
Process Filling
Food Safety Fundamentals Facility and Equipment Design
Hazard Analysis and Risk-Based Preventive Controls (HARPC)
Pest Control
Environmental Monitoring Preventative Maintenance
Allergen Controls Calibration
Sanitation Utilities Control
Foreign Material Control Purchasing Controls
Good Manufacturing Practice Program (GMP)
Control & Inspection of Goods
Batch Record Documentation Lab Controls
Specifications Warehouse and Distribution
21CFR Part 111
QS Categories:
Administration & Regulatory
Quality System Management
CAPA
Supplier Qualification
Food Safety
Facilities
Production & Process Control
Laboratory Controls
Warehouse & Distribution
21CFR Part 117
FSMA
Label Compliance
ANSI / NSF 173
GMP Audit Scope
NSF INTERNATIONAL | 24NSF INTERNATIONAL | 24
TOP 10 NSF Audit Findings
1. Batch Production Records2. Pest Controls3. Equipment and utensils 4. Quality Control Personnel 5. Walls, floors and ceilings cleanliness6. Sanitation Program for equipment, tools, instruments, etc.7. Contamination Controls8. Supplier Qualification 9. Maintenance Program for equipment, tools, instruments, etc.10.Verification vs. Validation
NSF INTERNATIONAL | 25NO. MISSTEPS COMPLIANCE OPTIONS
1. BPR does not follow MMR for each step. • Align BPR with MMR for all process stages• BPR/MMR available for all product skus• BPR/MMR managed through the Document
Control Process• Quality final sign-off• Double signatures
2. Prevent entrance by pests and animals • Documented Pest Control Program• Pest Control is inclusive of insects, rodents,
pets, birds, bats, etc.• Controls are physical, chemical or biological• Screens, bait, ketch-all traps or lights, etc.
3. Equipment and utensils protect from contamination
• Made of non-porous materials• Inspected frequently to assure no missing
pieces• Dedicated equipment and utensils• Storage of equipment and utensils
NSF INTERNATIONAL | 26NO. MISSTEPS COMPLIANCE OPTIONS
4. Quality Control Personnel established roles and responsibilities.
• Position Descriptions • Quality roles and responsibilities defined• Roles and responsibilities align with Part 111• Review and release product, deviations, specifications, etc.
roles defined• Signed and dated• Reviewed periodically
5. Walls, floors, ceiling adequately cleaned and in good repair
• No visible soil or contamination• Master Cleaning/Sanitation Schedule• Cleaning frequency defined, implemented, inspected• No holes, flaking paint, damaged, etc.
6. All equipment, instruments, utensils, contact surfaces must be maintained, cleaned and sanitized
• Equipment and instruments are uniquely identified• Manufacturer recommended frequency• Maintenance activities defined • Equipment and instruments are part of the MCS• Cleaning activities and frequency are defined with a risk based
approach• Inspection and approval of cleaning activities
NSF INTERNATIONAL | 27
0
10
20
30
40
50
60
FDA Dietary Supplements cGMP Violations^(2013 - 2018)
Qty %
60% Violations
^Cara Welch, Ph.D., Senior AdvisorFDA Office of DS Programs
NSF INTERNATIONAL | 28NSF INTERNATIONAL | 28
Aggregated Top NSF/FDA Findings
> Documentation - MMRs, MBRs, Product Specs
> Pest Control> Equipment Calibration and
Maintenance> Contamination prevention facility
cleanliness> Adequate testing procedures> Traceability / supply chain qualification> Establish and document specifications
for product and component identity, purity, strength, and composition
NSF INTERNATIONAL | 29
OUR MISSION
NSF International is dedicated to being the leadingglobal provider of public health and safety-based risk management solutions while serving the interests of all stakeholders, namely the public, the business community and government agencies.
NSF International is a global, independent public health and safety organization.
Our mission and focus has always beenprotecting and improving human health.
NSF INTERNATIONAL | 30
Thank You
NSF Health Sciences Certification Program
Lisa Glymph Lattimore
Senior Global Regulatory Technical Manager
856-381-8989
30