implementation of fda s current good manufacturing practices for dietary supplements n.
Download
Skip this Video
Download Presentation
Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements

Loading in 2 Seconds...

play fullscreen
1 / 87

Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements - PowerPoint PPT Presentation


  • 301 Views
  • Uploaded on

Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements. Current Good Manufacturing Practices (CGMP’s) for Dietary Supplements.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements' - hye


Download Now An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
current good manufacturing practices cgmp s for dietary supplements
Current Good Manufacturing Practices (CGMP’s) for Dietary Supplements

This final rule establishes the minimum CGMP’s to manufacturing, packing, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.

cgmp s
CGMP’s

The final rule is organized into 16 subparts that focus on specific aspects of the manufacturing process or addressing specific issues.

cgmp s1

CGMP’s

General Provisions

SubpartA

who is subject to this part 111 1
Manufacture, package, label or hold a dietary supplement.

Package, label or distribute manufactured by another firm.

Sell in bulk to a distributor

Imported or offered for import

Who is Subject to this Part?§111.1
other statutory provisions and regulations 111 5
Other Statutory Provisions and Regulations?§111.5

In addition to these regulations, you must comply with other applicable statutory provisions and regulations related to dietary supplements.

cgmp s2

CGMP’s

Personnel

Subpart B

personnel subpart b
Personnel Subpart B
  • Establish and follow written procedures
  • Microbial contamination
  • Qualified employees
  • Supervisor requirements
  • Record Keeping
cgmp s3

CGMP’s

Physical Plant and Grounds

Subpart C

physical plant and grounds subpart c
Physical Plant and GroundsSubpart C
  • Sanitation Requirements
  • Establish and follow written procedures
  • Design and Construction requirements
  • Record Keeping
cgmp s4

CGMP’s

Equipment and Utensils

Subpart D

equipment and utensils subpart d
Equipment and Utensils Subpart D
  • Establish and follow written procedures
  • Requirements
  • Automated, Mechanical, Electrical
  • Record Keeping
cgmp s5

CGMP’s

Production and Process Controls

Subpart E

production and process controls subpart e
Production and Process ControlsSubpart E
  • Implement a system of production and process controls
  • Design requirements
  • Quality Control Operations
  • Specifications
  • Responsibility of Specifications
production and process controls subpart e1
Production and Process ControlsSubpart E
  • Are Specifications met
  • What to do if specifications are not met
  • Representative samples
  • Reserve sample requirements
  • Material reviews and disposition decisions
production and process controls subpart e2
Production and Process ControlsSubpart E
  • Requirements to Treatments, In-process Adjustments and Reprocessing
  • Record Keeping
cgmp s6

CGMP’s

Control Requirements for Quality Control

Subpart F

controls requirements for quality control subpart f
Controls Requirements for Quality Control Subpart F
  • Establish and follow written procedures for 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 control subpart f1
Controls Requirements forQuality Control Subpart F
  • Quality control for equipment, instruments and controls
  • Quality control for components, packaging and labels before use
  • Quality control for master manufacturing record, batch record and manufacturing operations.
  • Quality control for Packaging and Labeling operations.
controls requirements for quality control subpart f2
Controls Requirements for Quality Control Subpart F
  • Quality control for returned dietary supplements
  • Quality control for Product Complaints
  • Record Keeping
cgmp s7

CGMP’s

Requirements for Components, Packaging and Labeling

Subpart G

requirements for components packaging labeling subpart g
Requirements for Components, Packaging, Labeling Subpart G
  • 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.
cgmp s8

CGMP’s

Master Manufacturing Record

Subpart H

master manufacturing record subpart h
Master Manufacturing Record Subpart H
  • Prepare and follow a written master manufacturing record for each unique formulation of dietary supplement
  • What the master record must include
cgmp s9

CGMP’s

Batch Production Record

Subpart I

batch production record
Batch Production Record
  • A batch production record must be established every time you manufacture a batch
  • Batch production record must include:
cgmp s10

CGMP’s

Batch Laboratory Operations

Subpart J

requirements for laboratory operations
Requirements forLaboratory Operations
  • Establish and follow written procedures
  • Use adequate laboratory facilities
  • Requirements for Laboratory control processes
  • Methods for testing and examination
cgmp s11

CGMP’s

Manufacturing Operations

Subpart K

manufacturing operations
Manufacturing Operations
  • Establish and follow written procedures for manufacturing operations
  • Ensure product specifications are consistent
  • Adequate sanitation principles
  • Prevent contamination
  • Appropriate disposition of rejected or unsuitable dietary supplements
cgmp s12

CGMP’s

Requirements for Packaging and Labeling Operations

Subpart L

requirements for packaging and labeling operations
Requirements for Packaging and Labeling Operations
  • You must establish and follow written procedures for packaging and labeling operations
  • Condition of packaging will ensure quality of dietary supplements
  • Requirements for filling, assembling packaging, labeling and related procedures
requirements for packaging and labeling operations1
Requirements for Packaging and Labeling Operations
  • Requirements for repackaging and relabeling
  • Packaged and labeled supplements rejected for distribution
  • Record Keeping
cgmp s13

CGMP’s

Holding and Distributing

Subpart M

holding and distributing
Holding and Distributing
  • 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
cgmp s14

CGMP’s

Returned Dietary Supplement

Subpart N

returned dietary supplements
Returned Dietary Supplements
  • Establish and follow written procedures under this subpart
  • Identify and quarantine returned dietary supplements
  • Destroy and suitably dispose of dietary supplements
  • Salvaging a returned dietary supplement
  • Requirements for reprocessed dietary supplements
returned dietary supplements1
Returned Dietary Supplements
  • Investigation of manufacturing processes and other batches
  • Record Keeping
cgmp s15

CGMP’s

Product Complaints

Subpart O

product complaints
Product Complaints
  • You must establish and follow written procedures to fulfill the requirements of this subpart
  • Review and investigation of product complaints
  • Record Keeping
cgmp s16

CGMP’s

Record and Recordkeeping

Subpart P

records and recordkeeping
Records and Recordkeeping
  • Recordkeeping requirements
  • Records that must be made available to FDA
slide43

Petition to Request Exemption from 100 Percent Identity Testing of Dietary IngredientsInterim Final Rule (IFR) 72 FR 34959 June 25, 2007

Ref: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements

slide44
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 you must: (1) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.
slide45
IFR
  • This identity testing requirement applies to a manufacturer who:
    • purchases a dietary ingredient from a dietary ingredient supplier
    • manufactures its own dietary ingredient for use in the manufacture of its dietary supplement.
slide46
IFR

FDA will consider, on a case-by-case basis, a manufacturer’s 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.

slide47
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
slide48
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 an exemption.
slide49
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,
slide50
IFR
  • 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.
slide51
IFR
  • Note: FDA may Take into account other data and information that we may have—for example, from other manufacturers who use the same supplier—in order to reduce the 100 percent identity testing requirements applicable to the particular dietary ingredient from the particular supplier.
slide52
IFR
  • Confidential or trade secret information in a petition is not available for public disclosure, however this would not preclude the agency from considering information, such as that about a particular supplier’s reliability, when it considers whether to grant or deny other petitions for exemption from 100 percent identity testing from other manufacturers.
slide53
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 and type of data it recommends be included in the citizen petition.
  • The guidance will include our recommendations about the type of information that a manufacturer could obtain about each supplier that it intends to use for the ingredient and its specifications that would assist us in evaluating the petition.
slide54
IFR
  • The approval of an exemption petition will be only for the dietary ingredient(s) and supplier(s), requested in the petition.
slide55
IFR
  • 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 information that are specific to each dietary ingredient and each supplier.
    • If the manufacturer changes dietary ingredient(s) or supplier(s), or any other combination thereof, FDA’s approval would not apply to the particular changed dietary ingredient
slide56
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 manufacturer’s 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.
slide57
IFR
  • The manufacturer would be responsible for documenting the tests and examinations for the dietary ingredient under the terms specified by FDA when the petition is granted, and must make and keep such records under § 111.325 (21 CFR 111.325).
slide58
IFR
  • Firm requesting petition must also maintain records of FDA action on the petition
  • If verification testing conducted by the manufacturer 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 that dietary ingredient and supplier would no longer be in effect.
slide59
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.
current dsgmp s

Current DSGMP’s

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.

general provisions
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.
personnel
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.
physical plant grounds
Physical Plant & Grounds
  • Sanitation - written procedures will be in place for all sanitation and pest control activities.
  • Records that demonstrate that water used as an ingredient is “safe and sanitary”
physical plant grounds1
Physical Plant & Grounds
  • Physical Plant requirements – areas identified for receiving, in-process and holding activities among others.
  • Look at what system the firm has in place for keeping track of the requirements under this part.
equipment and utensils
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
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 quality control 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 dsgmp s1
Current DSGMP’s
  • Investigators will be looking at new procedures, new records, new data sheets.
  • Ask questions to your Investigator or Consumer Safety Officer
  • Don’t wait until the last minute.
slide69
Janice Oliver

Deputy Director, CFSAN

slide70
Vasilios H. Frankos, Ph.D.

Dir., Division of Dietary Supplements

CFSAN

slide71
Brad Williams

Special Asst. to Division Director

Division of Dietary Supplements

CFSAN

slide72
Sara Dent Acosta, MS, MPH

Consumer Safety Officer

LOS-DO, FDA

slide77
Inspections and

Other Considerations

slide78
Moderator:

Monika Samtani

slide79
Panelists/Presenters:

Dr. Vasilios Frankos

Brad Williams

Sara Dent Acosta

slide80
Writer:

Angela Pope, MBA

Consumer Safety Officer

FDA/CFSAN/ONLDS

slide81
Technical Assistance:

Dr. Robert Moore, PhD

Dr. Kenneth Taylor, PhD

Constance Hardy

Linda Webb

slide82
In case of Trouble:

Check with your IT department.

If unsuccessful, call:

1-888-626-8730

slide83
Phone Bridge:

1-888-469-1348

Access code:

5428315

slide84
Produced at the

FDA TV Studios, Division of Communication Media

Producer/Director

Glenn Scimonelli

Assistant Director

Barbara Ann Richards

Audio

Rodney Ladson

Floor Director

Rick Markley

slide85
Cameras

Stan Rose

Patty Edwards

Marty Martin

Stefan Monica

Lighting Director

Jim Sweeny

Graphics/IT Support

Dave Bailey

slide86
Videotape

Barry Goldstein

Phone/Fax/Email

Mike Sobola

PowerPoint

Kenton Frederic

Teleprompter

Jeannie Vinson

Makeup

Kim Foley

slide87
Engineering Services

Jon Fleetwood

Contract Video Specialists

Division Director

Dr. Robert McCleary