dscgmps9
TRANSCRIPT
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Implementation of FDAs
Current Good Manufacturing
Practices for DietarySupplements
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Current Good Manufacturing
Practices (CGMPs) for DietarySupplements
This final rule establishes the minimum
CGMPs to manufacturing, packing,labeling, or holding dietary supplements
to ensure the quality of the dietary
supplement.
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CGMPs
The final rule is organized into 16subparts that focus on specific aspects
of the manufacturing process or
addressing specific issues.
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CGMPs
General Provisions
SubpartA
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Who is Subject to this Part?
111.1
Manufacture, package, label or hold a dietarysupplement.
Package, label or distribute manufactured byanother firm.
Sell in bulk to a distributor
Imported or offered for import
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Definitions
111.3Actual Yield Batch Batch Number,
Lot Number,
Control Number
Component Contact Surface
Ingredient In-Process
Material
Lot Microorganisms Must
Pest Physical plant Product complaint Quality Quality Control
Quality control
Personnel
Representative
sample
Reprocessing Reserve Sample Sanitize
Theoretical yield Water activity We You
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Other Statutory Provisions and
Regulations?111.5
In addition to these regulations, youmust comply with other applicable
statutory provisions and regulations
related to dietary supplements.
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CGMPs
Personnel
Subpart B
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Personnel
Subpart B
Establish and follow written
procedures Microbial contamination
Qualified employees
Supervisor requirements
Record Keeping
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CGMPs
Physical Plant and Grounds
Subpart C
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Sanitation Requirements
Establish and follow writtenprocedures
Design and Construction requirements
Record Keeping
Physical Plant and Grounds
Subpart C
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CGMPs
Equipment and Utensils
Subpart D
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Establish and follow written procedures
Requirements Automated, Mechanical, Electrical
Record Keeping
Equipment and Utensils
Subpart D
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CGMPs
Production and Process
Controls
Subpart E
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Implement a system of production andprocess controls
Design requirements
Quality Control Operations
Specifications
Responsibility of Specifications
Production and Process
ControlsSubpart E
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Are Specifications met
What to do if specifications are not met
Representative samples
Reserve sample requirements
Material reviews and disposition decisions
Production and Process
ControlsSubpart E
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Requirements to Treatments, In-process Adjustments and
Reprocessing
Record Keeping
Production and Process
ControlsSubpart E
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CGMPs
Control Requirements forQuality Control
Subpart F
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Establish and follow written proceduresfor the quality control operations unit.
What Quality Control Personnel must do
Quality control for Laboratory operations
Material review and disposition decisions
Controls Requirements for
Quality ControlSubpart F
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Quality control for equipment, instruments and controls
Quality control for components, packaging and labelsbefore use
Quality control for master manufacturing record, batchrecord and manufacturing operations.
Quality control for Packaging and Labeling operations.
Controls Requirements for
Quality ControlSubpart F
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Quality control for returned dietarysupplements
Quality control for Product Complaints
Record Keeping
Controls Requirements for
Quality ControlSubpart F
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CGMPs
Requirements for Components,Packaging and Labeling
Subpart G
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Establish and follow written procedures
Requirements to components
Requirements to packaging and labels received
Requirements to products received for
packaging or labeling Requirements for rejected packaging and
labeling.
Requirements for Components,
Packaging, LabelingSubpart G
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CGMPs
Master Manufacturing Record
Subpart H
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Prepare and follow a written master
manufacturing record for each unique
formulation of dietary supplement
What the master record must include
Master Manufacturing Record
Subpart H
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CGMPs
Batch Production Record
Subpart I
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A batch production record must be
established every time youmanufacture a batch
Batch production record must include:
Batch Production Record
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CGMPs
Batch Laboratory Operations
Subpart J
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Requirements for
Laboratory Operations
Establish and follow written
procedures
Use adequate laboratory facilities
Requirements for Laboratory
control processes Methods for testing and
examination
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CGMPs
Manufacturing Operations
Subpart K
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Establish and follow written procedures for
manufacturing operations
Ensure product specifications are consistent Adequate sanitation principles
Prevent contamination
Appropriate disposition of rejected orunsuitable dietary supplements
Manufacturing Operations
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CGMPs
Requirements for Packaging andLabeling Operations
Subpart L
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You must establish and follow written
procedures for packaging and labelingoperations
Condition of packaging will ensure quality of
dietary supplements Requirements for filling, assembling
packaging, labeling and related procedures
Requirements for Packaging
and Labeling Operations
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Requirements for repackaging and
relabeling
Packaged and labeled supplements
rejected for distribution
Record Keeping
Requirements for Packaging
and Labeling Operations
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CGMPs
Holding and Distributing
Subpart M
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Establish and follow written procedures for holding
and distributing operations
Requirements to hold components, supplements,packaging and labels
Requirements for in-process materials
Requirements for reserve samples
Distribution requirements to protect against
contamination and deterioration
Holding and Distributing
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CGMPs
Returned Dietary Supplement
Subpart N
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Establish and follow written procedures under this
subpart
Identify and quarantine returned dietarysupplements
Destroy and suitably dispose of dietary
supplements
Salvaging a returned dietary supplement
Requirements for reprocessed dietary supplements
Returned Dietary Supplements
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Investigation of manufacturing
processes and other batches
Record Keeping
Returned Dietary Supplements
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CGMPs
Product ComplaintsSubpart O
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You must establish and follow written
procedures to fulfill the requirements of
this subpart
Review and investigation of product
complaints
Record Keeping
Product Complaints
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CGMPs
Record and RecordkeepingSubpart P
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Recordkeeping requirements
Records that must be madeavailable to FDA
Records and Recordkeeping
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Petition to Request Exemption from 100 Percent Identity
Testing of Dietary Ingredients
Interim Final Rule (IFR)
72 FR 34959 June 25, 2007
Ref: Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling or Holding
Operations for Dietary Supplements
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IFR
Requirement for 100 percent identity testing of
dietary ingredients is found at Subpart E
Requirement to Establish a Production and
Process Control System, 111.75 What must
you do to determine whether specifications are
met? in the CGMP final rule.
111.75(a)(1) Before you a component youmust: (1) Conduct at least one appropriate test
or examination to verify the identity of any
component that is a dietary ingredient.
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This identity testing requirement applies
to a manufacturer who:
purchases a dietary ingredient from adietary ingredient supplier
manufactures its own dietary
ingredient for use in the manufactureof its dietary supplement.
IFR
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IFR
FDA will consider, on a case-by-case basis, a
manufacturers conclusion, supported by
appropriate data and information in the petition
submission, that it has developed a system that it
would implement as a sound, consistent means
of establishing, with no material diminution of
assurance compared to the assurance provided
by 100 percent identity testing, the identity of the
dietary ingredient before use.
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IFR
The petition needs to set forth, at minimum:
Scientific Rationale for requested
exemption Supporting Data and information
Documenting and careful analysis of any
variability or errors in incoming product
Alternative testing proposal
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IFR
Under this IFR, firms will be granted
exemption from the requirement of 100
percent identity testing only when a manufacturer petitions the agency
under 10.30 and
the agency grants such anexemption.
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IFR
10.30 (21 CFR 10.30), the citizen
petition process requires your petition to
include: The action requested (i.e., a request
for an exemption from the
requirements of 111.75(a)(1)(i));A statement of grounds;
A section on environmental impact,
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A statement certifying that, to the best of your
knowledge and belief, your petition includes all
information and views on which the petition
relies, and that it includes representative data
and information known to you which are
unfavorable to the petition.
Identify any information in the petition that is
confidential commercial or trade secret
information
Should segregate such information from other
information in your petition.
IFR
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IFR
Note: FDA may Take into account other
data and information that we may
havefor example, from othermanufacturers who use the same
supplierin order to reduce the 100
percent identity testing requirementsapplicable to the particular dietary
ingredient from the particular supplier.
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Confidential or trade secret information in
a petition is not available for public
disclosure, however this would notpreclude the agency from considering
information, such as that about a particular
suppliers reliability, when it considers
whether to grant or deny other petitions forexemption from 100 percent identity
testing from other manufacturers.
IFR
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IFR
FDA has no preconceived notions of what would
constitute a successful petition. As we gain
experience in this area:
FDA will issue guidance on the information andtype of data it recommends be included in the
citizen petition.
The guidance will include our recommendations
about the type of information that a manufacturercould obtain about each supplier that it intends to
use for the ingredient and its specifications that
would assist us in evaluating the petition.
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IFR
The approval of an exemption
petition will be only for the dietary
ingredient(s) and supplier(s),requested in the petition.
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Manufacturers may use one petition to request an
exemption from 100 percent identity testing for one or
more dietary ingredients and one or more suppliers;
The petition needs to provide data and informationthat are specific to each dietary ingredient and
each supplier.
If the manufacturer changes dietary ingredient(s)
or supplier(s), or any other combination thereof,FDAs approval would not apply to the particular
changed dietary ingredient
IFR
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IFR
If the petition is granted, 111.75(a)(1)(i) would require
the manufacturer to implement the system identified in the
petition.
scientific method developed by the manufacturer identity may include physical characteristics (such as
crystal or powder), state of hydration, or part of the
plant (roots or leaves). The term identity would
include the manufacturers specification (s) that would
identify the attributes a supplier must meet.demonstrating that less than 100 percent identity
testing did not materially diminish assurance that the
dietary ingredient is the correct dietary ingredient.
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The manufacturer would be responsible
for documenting the tests and
examinations for the dietary ingredientunder the terms specified by FDA when
the petition is granted, and must make
and keep such records under 111.325(21 CFR 111.325).
IFR
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IFR
Firm requesting petition must also maintain
records of FDA action on the petition
If verification testing conducted by themanufacturer under the approved petition
results in failure of any component which is a
dietary ingredient to meet its identity
specification (s), the FDA approval for thatdietary ingredient and supplier would no
longer be in effect.
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IFR
Manufacturer would return to 100
percent identity testing until it can
re-petition FDA for a new exemption,and that re-petition is approved.
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Current DSGMPs
Inspections of Dietary Supplement firms:
There are a variety of firms of different
sizes and performing different activities
that will be subject to the new regulations.
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General Provisions
Applying new definitions during an inspection:
finished product, component and ingredient
Verifying if a component:
is an approved dietary ingredient, a new
dietary ingredient, a food substance or in
another category such as GRAS substance
or approved colors.
P l
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Personnel
Personnel requirements
Similar to what firms should already be doing
while preparing foods, including dietary
supplements
Procedures must be in writing and firms will
have to demonstrate they have trained their
employees in the procedures, that the
procedures are implemented and that they
are followed.
Ph i l Pl t & G d
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Physical Plant & Grounds
Sanitation - written procedures will
be in place for all sanitation and pestcontrol activities.
Records that demonstrate that water
used as an ingredient is safe andsanitary
Ph i l Pl t & G d
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Physical Plant & Grounds
Physical Plant requirements areas
identified for receiving, in-process andholding activities among others.
Look at what system the firm has in
place for keeping track of the
requirements under this part.
Equipment and Utensils
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Equipment and Utensils
Calibration - procedures and records of calibration
and preventive maintenance.
pH meters, thermometers, chart recorders,
scales
Keep in mind that many digital thermometers cannot
be adjusted; therefore calibration can only be
verified.
The records of this part will need to be reviewed by
Quality Personnel
Backup storage of Electronic records.
Production and Process Control
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Production and Process Control
Master Manufacturing record
written, implemented and followed.
Requirements of subparts E through L of this
part must be reviewed and approved by qualitycontrol personnel.
Items that need to be reviewed and approved there
should be a signature indicating the review and
approval.
Words that will be an important part of inspections
are: Specifications - Quality Identity Purity
Strength - Composition
Current DSGMPs
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Current DSGMPs
Investigators will be looking at new
procedures, new records, new datasheets.
Ask questions to your Investigator or
Consumer Safety Officer
Dont wait until the last minute.
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Monika Samtani
Moderator
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Janice Oliver
Deputy Director, CFSAN
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Vasilios H. Frankos, Ph.D.Dir., Division of Dietary Supplements
CFSAN
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Brad WilliamsSpecial Asst. to Division Director
Division of Dietary Supplements
CFSAN
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Sara Dent Acosta, MS, MPH
Consumer Safety OfficerLOS-DO, FDA
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Implementation of Current Good
Manufacturing Practices forDietary Supplements
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Sub Parts A - C
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Sub Parts D - P
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Interim Final Rule
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Inspections and
Other Considerations
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Moderator:
Monika Samtani
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Panelists/Presenters:
Dr. Vasilios Frankos
Brad Williams
Sara Dent Acosta
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Writer:
Angela Pope, MBA
Consumer Safety Officer
FDA/CFSAN/ONLDS
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Technical Assistance:Dr. Robert Moore, PhD
Dr. Kenneth Taylor, PhDConstance Hardy
Linda Webb
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In case of Trouble:Check with your IT
department.If unsuccessful, call:
1-888-626-8730
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Phone Bridge:1-888-469-1348
Access code:
5428315
Produced at the
FDA TV Studios, Division of Communication Media
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Producer/DirectorGlenn Scimonelli
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Audio
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Stan Rose
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Lighting Director
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Dave Bailey
Videotape
Barry Goldstein
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Barry Goldstein
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