IFAC’s cGMP Audit Guide
How the Food Ingredient Industry has Responded
to FSMA and Food Safety Audits
Priscilla Zawislak
Global Regulatory Affairs Manager
IFT Annual Meeting
July 16, 2013
Ashland Specialty Ingredients
IFAC’s cGMP & Audit Guide – WHY?
• Current Good Manufacturing Practices (cGMPs)
are about preventive controls which are
necessary for food additives per 21 CFR 110 with
a focus on food safety risks:
– Foreign materials
– Labeling (such as allergens)
• Food Safety Modernization Act (FSMA) elevates
food safety to outline guidelines for HARPC
• FDA’s draft Preventive Controls Rule does not
address the unique needs of food additives
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Ashland Specialty Ingredients
IFAC’s cGMP & Audit Guide – WHY?
• Processes for manufacturing food additives are
often different than manufacturing finished foods
– Food safety risks are often different
– Different preventive controls & cGMPs are needed
• Food industry 3rd party audit standards, e.g. GFSI
audit programs, do not have the flexibility needed
for food additives
• Most customer and 3rd party auditors are not
familiar with food additive manufacturing
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Ashland Specialty Ingredients
IFAC’s cGMP & Audit Guide – WHY?
• The IFAC guides adapt
cGMP requirements and
3rd party audit standards to
food additives
– Most food safety audit
standards are similar
but interpretation of the
provisions as they
apply to food additives
varies
– Provide auditors with a
more relevant guide for
conducting food
additives audits
Ashland Specialty Ingredients
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IFAC cGMP Audit Guide
• IFAC developed a recommended guide for the safe
manufacture of food additives
• The IFAC cGMP Guide presents a focus on food additive
production vs a general overview per 21 CFR 110
• Also applicable to these materials for use in dietary
supplements
• Provides a more unified approach to these principles for
food additives
• Covers the Quality Management System (QMS) & cGMPs
necessary throughout manufacturing for both batch and
continuous processes to prevent food safety problems
• Covers FSMA requirements applicable to food additives
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Hazard Assessment & Risk Management
• A science & risk-based approach is needed to
identify and implement appropriate practices and
procedures necessary to protect against
contamination of products
– Food additives represent a wide range of products with
varied processing technologies
– Food additive grades may only be manufactured a few
times/year in a process that makes industrial to
pharmaceutical grade products
– Food additives must meet established specifications
and cGMP requirements even though some food
additives may undergo additional processing before
reaching the consumer
Ashland Specialty Ingredients
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Food Additive cGMPs
• Risk Management and Change Control are key elements
in the QMS and cGMPs
– Focus is on prevention vs reacting to problems that
could cause food safety events
• Identify hazards
• Implement steps to minimize or prevent hazards
• Identify monitoring procedures
• Record results
• Specify actions to correct problems that arise
– Many food additive companies have had these
systems in place for a long time to meet pharma
requirements
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Change Control/Management of Change
• Changes are evaluated to assess the impact on
the quality and the safety of the food additive
• Programs are in place for raw material and
supplier qualification
• Management of Change is used to request &
document changes and includes an evaluation of
impact on HACCP and cGMP products
• Management of Change for process safety has been
an established practice by many companies in our
industry for decades, often….
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Food Additives vs Finished Foods
GMPs & Food Safety Differences
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Differences in Hazard Analysis
• Environmental Risks & Monitoring
– While some food additives are not high risk for
microorganisms
• Most do not have compendial micro specifications
• Many processes and raw materials minimize
microbial contamination risks
– Environmental pathogen testing has its place in the
hazard analysis
• Manufacturing environment is part of the hazard
analysis
– Packaging areas practices follow cGMP guidelines to
mitigate potential for product adulteration,
contamination and mislabeling
Ashland Specialty Ingredients
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Differences in Hazard Analysis
• Sanitation & Hygiene Practices & Controls
– Different controls & cleaning requirements for batch vs
continuous processes
– Gloves & PPEs protect against physical &
environmental hazards and there is usually little or no
direct handling of product by production personnel
– Special practices usually only needed for products that
are more sensitive to contamination
– Controls must be suitable for a wide range of products
and conditions
– Hygiene & training best practices are tailored based on
the risk assessment for food additives
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Differences in Hazard Analysis
• Food Safety Plan
– Many plants manufacture excipients and personal care
ingredients in addition to food additives in the same
processes under similar controls
– Supplier & raw material qualification needs are focused on
quality and suitability for intended use
• Food Defense Plan
– Food additive plants typically have multiple levels of security
to control access to areas
– Intentional contamination risks are low
– Most food additive suppliers have established programs to
ensure supply chain security
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Differences in Hazard Analysis
• Allergen Control
– Must be risk-based
• A control plan should be based on risks
– Procedures for setting allergen control
requirements should be practical
• Focus on potentials for cross-contamination
including raw materials storage, production areas,
packaging areas and warehouses
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Ashland Specialty Ingredients
Summary
• Risk assessment, change management and
implementation of preventive controls for food additives is
essential to production of a product suitable for its
intended use
• Economically motivated adulteration & other
contamination is controlled through adherence to cGMPs,
including supplier qualification & verification for raw
materials
• Flexibility is needed to adapt required controls to the
unique situation and allow companies to identify best
practices and preventive controls to enhance food safety
and consumer health without being overly burdensome
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Next Steps
• Publication of IFAC GMP Audit Guide
• IFAC webinars on cGMP & Audit Guide
• Industry communication & awareness
• Goal - adoption by 3rd party food safety auditing
organizations
• Goal - recognition by US FDA
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Thank You!
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