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

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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 Supplements

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 Supplements

General Provisions

SubpartA


Who is subject to this part 111 1

Manufacture, package, label or hold a dietary supplement. Supplements

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? Supplements§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 Supplements

Personnel

Subpart B


Personnel subpart b
Personnel SupplementsSubpart B

  • Establish and follow written procedures

  • Microbial contamination

  • Qualified employees

  • Supervisor requirements

  • Record Keeping


Cgmp s3

CGMP’s Supplements

Physical Plant and Grounds

Subpart C


Physical plant and grounds subpart c
Physical Plant and Grounds SupplementsSubpart C

  • Sanitation Requirements

  • Establish and follow written procedures

  • Design and Construction requirements

  • Record Keeping


Cgmp s4

CGMP’s Supplements

Equipment and Utensils

Subpart D


Equipment and utensils subpart d
Equipment and Utensils Supplements Subpart D

  • Establish and follow written procedures

  • Requirements

  • Automated, Mechanical, Electrical

  • Record Keeping


Cgmp s5

CGMP’s Supplements

Production and Process Controls

Subpart E


Production and process controls subpart e
Production and Process Controls SupplementsSubpart 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 Controls SupplementsSubpart 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 Controls SupplementsSubpart E

  • Requirements to Treatments, In-process Adjustments and Reprocessing

  • Record Keeping


Cgmp s6

CGMP’s Supplements

Control Requirements for Quality Control

Subpart F


Controls requirements for quality control subpart f
Controls Requirements for Quality Control Supplements 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 for SupplementsQuality 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 Supplements Subpart F

  • Quality control for returned dietary supplements

  • Quality control for Product Complaints

  • Record Keeping


Cgmp s7

CGMP’s Supplements

Requirements for Components, Packaging and Labeling

Subpart G


Requirements for components packaging labeling subpart g
Requirements for Components, Packaging, Labeling Supplements 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 Supplements

Master Manufacturing Record

Subpart H


Master manufacturing record subpart h
Master Manufacturing Record Supplements 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 Supplements

Batch Production Record

Subpart I


Batch production record
Batch Production Record Supplements

  • A batch production record must be established every time you manufacture a batch

  • Batch production record must include:


Cgmp s10

CGMP’s Supplements

Batch Laboratory Operations

Subpart J


Requirements for laboratory operations
Requirements for SupplementsLaboratory Operations

  • Establish and follow written procedures

  • Use adequate laboratory facilities

  • Requirements for Laboratory control processes

  • Methods for testing and examination


Cgmp s11

CGMP’s Supplements

Manufacturing Operations

Subpart K


Manufacturing operations
Manufacturing Operations Supplements

  • 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 Supplements

Requirements for Packaging and Labeling Operations

Subpart L


Requirements for packaging and labeling operations
Requirements for Packaging and Labeling Operations Supplements

  • 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 Supplements

  • Requirements for repackaging and relabeling

  • Packaged and labeled supplements rejected for distribution

  • Record Keeping


Cgmp s13

CGMP’s Supplements

Holding and Distributing

Subpart M


Holding and distributing
Holding and Distributing Supplements

  • 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 Supplements

Returned Dietary Supplement

Subpart N


Returned dietary supplements
Returned Dietary Supplements 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 Supplements

  • Investigation of manufacturing processes and other batches

  • Record Keeping


Cgmp s15

CGMP’s Supplements

Product Complaints

Subpart O


Product complaints
Product Complaints Supplements

  • 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 Supplements

Record and Recordkeeping

Subpart P


Records and recordkeeping
Records and Recordkeeping Supplements

  • Recordkeeping requirements

  • Records that must be made available to FDA


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


IFR Testing of Dietary Ingredients

  • 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.


IFR Testing of Dietary Ingredients

  • 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.


IFR Testing of Dietary Ingredients

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.


IFR Testing of Dietary Ingredients

  • 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


IFR Testing of Dietary Ingredients

  • 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.


IFR Testing of Dietary Ingredients

  • § 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,


IFR Testing of Dietary Ingredients

  • 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 Testing of Dietary Ingredients

  • 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.


IFR Testing of Dietary Ingredients

  • 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.


IFR Testing of Dietary Ingredients

  • 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.


IFR Testing of Dietary Ingredients

  • The approval of an exemption petition will be only for the dietary ingredient(s) and supplier(s), requested in the petition.


IFR Testing of Dietary Ingredients

  • 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


IFR Testing of Dietary Ingredients

  • 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.


IFR Testing of Dietary Ingredients

  • 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).


IFR Testing of Dietary Ingredients

  • 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.


IFR Testing of Dietary Ingredients

  • 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 Testing of Dietary Ingredients

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 Testing of Dietary Ingredients

  • 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 Testing of Dietary Ingredients

  • 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 Testing of Dietary Ingredients

  • 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 Testing of Dietary Ingredients

  • 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 Testing of Dietary Ingredients

  • 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 Testing of Dietary Ingredients

  • 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 Testing of Dietary Ingredients

  • 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.


Monika Samtani Testing of Dietary Ingredients

Moderator


Janice Oliver Testing of Dietary Ingredients

Deputy Director, CFSAN


Vasilios H. Frankos, Ph.D. Testing of Dietary Ingredients

Dir., Division of Dietary Supplements

CFSAN


Brad Williams Testing of Dietary Ingredients

Special Asst. to Division Director

Division of Dietary Supplements

CFSAN


Sara Dent Acosta, MS, MPH Testing of Dietary Ingredients

Consumer Safety Officer

LOS-DO, FDA



Sub Parts A - C Dietary Supplements


Sub Parts D - P Dietary Supplements


Interim Final Rule Dietary Supplements


Inspections and Dietary Supplements

Other Considerations


Moderator: Dietary Supplements

Monika Samtani


Panelists/Presenters: Dietary Supplements

Dr. Vasilios Frankos

Brad Williams

Sara Dent Acosta


Writer: Dietary Supplements

Angela Pope, MBA

Consumer Safety Officer

FDA/CFSAN/ONLDS


Technical Assistance: Dietary Supplements

Dr. Robert Moore, PhD

Dr. Kenneth Taylor, PhD

Constance Hardy

Linda Webb


In case of Trouble: Dietary Supplements

Check with your IT department.

If unsuccessful, call:

1-888-626-8730


Phone Bridge: Dietary Supplements

1-888-469-1348

Access code:

5428315


Produced at the Dietary Supplements

FDA TV Studios, Division of Communication Media

Producer/Director

Glenn Scimonelli

Assistant Director

Barbara Ann Richards

Audio

Rodney Ladson

Floor Director

Rick Markley


Cameras Dietary Supplements

Stan Rose

Patty Edwards

Marty Martin

Stefan Monica

Lighting Director

Jim Sweeny

Graphics/IT Support

Dave Bailey


Videotape Dietary Supplements

Barry Goldstein

Phone/Fax/Email

Mike Sobola

PowerPoint

Kenton Frederic

Teleprompter

Jeannie Vinson

Makeup

Kim Foley


Engineering Services Dietary Supplements

Jon Fleetwood

Contract Video Specialists

Division Director

Dr. Robert McCleary


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