Usfda canned food regulations thermal processing deviations registration and process filing
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USFDA Canned Food Regulations Thermal Processing Deviations Registration and Process Filing. William W. Deckert Jr. Low-acid canned foods Acidified foods. A compilation of title 21 code of federal regulations, parts 108, 113, and 114. Part 108 - Emergency permit control.

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Usfda canned food regulations thermal processing deviations registration and process filing

USFDA Canned Food RegulationsThermal Processing DeviationsRegistration and Process Filing

William W. Deckert Jr.


Low acid canned foods acidified foods

Low-acid canned foodsAcidified foods

  • A compilation of title 21 code of federal regulations, parts 108, 113, and 114


Part 108 emergency permit control

Part 108 - Emergency permit control

  • Subpart A - General Provisions

    • 108.3 Definitions

      • a- the definitions contained in section 201 of the Federal Food, Drug, and cosmetic Act are applicable to such terms when used in this part.

      • b- Commissioner

      • c- Act

      • Permit

      • Manufacture, processing, or packing of food in any locality


Usfda canned food regulations thermal processing deviations registration and process filing

  • 108.5- Determination of the need for a permit.

  • 108.6- Revocation of determination of need for permit.

  • 108.7- Issuance or denial of permit.

  • 108.10- Suspension and reinstatement of permit.

  • 108.12- Manufacturing, processing, or packing without a permit, or in violation of a permit.

  • 108.19- Establishment of requirements for exemption from section 404 of the act.


Usfda canned food regulations thermal processing deviations registration and process filing

Subpart B - Specific requirements and conditions for exemption from or compliance with an emergency permit

  • 108.25- Acidified foods.

  • 108.35- Thermal processing of low-acid foods packaged in hermetically sealed containers.


Part 113 thermally processed low acid foods packaged in hermetically sealed containers

Part 113 - Thermally processed low-acid foods packaged in hermetically sealed containers

  • Subpart A- General provisions

    • 113.3- Definitions:

      a) Aseptic processing and packaging

      b) Bleeders

      c) Come-up-time

      d) Commercial processor

      e) Commercial sterility

      f) Critical factor

      g) Flame sterilizer

      h) Headspace, gross


Usfda canned food regulations thermal processing deviations registration and process filing

I) Headspace, net

j) Hermetically sealed containers

k) Incubation

l) Initial temperature

m) Lot

n) Low-acid foods

o) Minimum thermal process

p) Operating process

q) Retort

r) Scheduled process

s) Shall

t) Should

u) Vacuum-packed products

v) Vents

w) Water activity (aw)


Usfda canned food regulations thermal processing deviations registration and process filing

  • 113.5- Current good manufacturing practice.

  • 113.10- Personnel


Subpart c equipment

Subpart C - Equipment

  • 113.40- Equipment and procedures.

    (figure page 220, 221, 224)


Subpart d control of components food product containers closures and in process materials

Subpart D - Control of components, food product containers, closures, and in-process materials

  • 113.60- Containers.

    a) Closures

    b) Cooling water

    c) Coding

    d) Post process handling

    (figure page 236)


Subpart e production and process control

Subpart E - Production and Process Control

  • 113.81- Product preparation.

  • 113.87- Operations in the thermal processing room.

  • 113.89- Deviations in processing, venting, or control of critical factors.


Subpart f records and reports

Subpart F - Records and Reports

  • 113.100- Processing and production records.


Part 114 acidified foods

Part 114 - Acidified Foods

  • Subpart A- General Provisions

    • 114.3- Definitions.

      A) Acid foods

      b) Acidified foods

      c) Lot

      d) Low-acid foods

      e) Scheduled process

      f) Shall

      g) Should

      h) Water activity (aw)


Usfda canned food regulations thermal processing deviations registration and process filing

  • 114.5- Current good manufacturing practice.

  • 114.10- Personnel.


Subpart e production and process controls

Subpart E - Production and Process Controls

  • 114.80- Processes and controls.

  • 114.83- Establishing scheduled processes.

  • 114.90- Methodology.


Subpart f records and reports1

Subpart F - Records and Reports

  • 114.100- Records.


Thermal processing deviations regulatory review fda

Thermal Processing DeviationsRegulatory ReviewFDA


Federal food drug and cosmetic act

Federal Food, Drug, and Cosmetic Act

  • Adulterated food

  • Emergency permit control

  • Imports and Exports


Usfda canned food regulations thermal processing deviations registration and process filing

21 CFR Code of Federal RegulationPart 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

(Thermal processing deviations (LACF))

  • 113.89- Deviations in processing, venting, or control of critical factors.

    (Thermal processing deviations (Acidified Foods)

    21CFR$114.89 Deviations from scheduled processes


Usfda canned food regulations thermal processing deviations registration and process filing

Title 21Food and DrugsChapter IFood and Drug AdministrationDepartment of Health and Human ServicesPart 108- Emergency Permit ControlTable of contents Subpart B- Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit

  • 108.35 Thermal processing of low-acid foods packaged in hermetically

  • sealed container

  • 108.35(a)


Usfda canned food regulations thermal processing deviations registration and process filing

Title 21Food and Drugs AdministrationDepartment of Health and Human ServicesPart 108- Emergency Permit Control

Table of Contents Subpart B - Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit

Sec.108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers

  • 108.35 - (k) imports


Usfda canned food regulations thermal processing deviations registration and process filing

Foreign and Domestic Low-acid Canned Food (LACF) and Acidified Food Establishment Inspection Report (EIR)Regulatory Review Considerations for Detention Without PhysicalExamination (DWPE) or Emergency PermitControl by FDA Compliance Officersin Order of Importance


Usfda canned food regulations thermal processing deviations registration and process filing

1- How are process deviations handled ?

2- Are scheduled processes properly delivered?

3- Were schedule processes properly developed?

4- Does documentation exist to confirm that uniform heat distribution is achieved in the firm’s processing system?

5- Does the firm follow its established schedule process?

6- Does the firm have necessary procedures in place to ensure container integrity?


How are process deviations handled

How are process deviations handled ?

Guide to inspections of low acid canned food manufacturers

Part 1- Administrative procedures/scheduled process

Process deviations

Detection and correction in-process

Reprocessing

Isolation of affected prodution

Sumissions to process authorities

Incomplete records


Usfda canned food regulations thermal processing deviations registration and process filing

Issues pertaining to evaluation

Reporting evaluation results to the processor


Emergency permit

Emergency permit

DWPE


Usfda canned food regulations thermal processing deviations registration and process filing

CANNING INDUSTRY

FDA 2541 Registration form

FDA 2541(A) Food process filing for all methods except low-acid aseptic

FDA CFSAN WEB SITE

AW, Ph List, Container conversion chart


Cfsan home page

CFSAN HOME PAGE

Http://www.cfsan.fda.gov/

Acidified and Low Acid Canned Foods

Imports and Exports

Industry Assistance

International/Codex/Other Languages


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