dietary supplement manufacturing: common missteps and what

NSF INTERNATIONAL | 1

NSF INTERNATIONAL789 N. Dixboro Road, Ann Arbor, Michigan 48105 USA

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A GLOBAL LEADER INPUBLIC HEALTH & SAFETY

Dietary Supplement Manufacturing: Common Missteps and What it Takes to Ensure Consumer Safety


Agenda NSF International Overview

NSF Dietary Supplements Program

GMP Registration Program

GMP Audits

Common Dietary Supplement Industry Missteps & Compliance


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 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-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.


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.


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

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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 GMP Audit Lifecycle

Facility Audit Technical ReviewCorrective Action Response Process

Monitoring Audit

DRAFT GMP Facility Audit Report

GMP Facility Audit

Report

• Calibration• Severity• Accuracy


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.


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


Comparison of Reactors (gelatin melter)

Acceptable Rejected


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


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


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


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.


Thank You

NSF Health Sciences Certification Program

Lisa Glymph Lattimore

Senior Global Regulatory Technical Manager

[email protected]

856-381-8989

30

mailto:[email protected]


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QUESTIONS

dietary supplement manufacturing: common missteps and what

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