Month: August 2024

Types of FCE-SID Process Filing forms

Low-acid canned food

A low-acid canned food has the following characteristics:

      1. Equilibrium pH value greater than 4.6 and water activity greater than 0.85.
      2. Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).
      3. Receives a heat treatment for the purpose of achieving commercial sterility.
      4. Normally stored and distributed under non-refrigerated conditions.

Acidified food

An acidified food is a low-acid food to which acid(s) or acid food(s) are added for the purpose of reducing the pH to a finished equilibrium pH of 4.6 or below. It has a water activity greater than 0.85 and is stored and distributed under nonrefrigerated conditions.

FDA requires manufacturers and processors of low acid canned and acidified food products to submit Food Canning establishment registration using Form 2541 and to submit process filing using Form 2541d, e, f and g.

Form 2541d – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541d is intended for:

  • Low-acid food products where the growth of microorganisms is controlled through the application of heat to foods.

Form 2541e – Commercial processors who manufacture, process, or pack thermally processed acidified foods packaged in hermetically sealed containers

Form 2541f – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541f is intended for

  • Low-acid food products where the growth of microorganisms is controlled through the amount of water available for microbiological growth (i.e. “water control” products); and
  • Low-acid food products where the growth of microorganisms is controlled through multiple physical and/or physicochemical hurdles (i.e. “formulation control” products).

Form 2541g – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541g is intended for:

  • Low-acid foods where the growth of microorganisms is controlled through the application of heat to foods and where the processing involves use of aseptic processing and packaging

Liberty management Group Ltd. can help companies to file FCE and SID process filings with FDA.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

HOW TO FILE A DMF

DMF (Drug Master File) is a confidential & detailed submission to FDA.

There are several steps involved in filing a DMF with the US FDA:

1. Determine the Type of DMF

Identify the type of DMF you need to file (Type II, III, IV, or V).

2. Prepare the DMF Document

  • Cover Letter: Include a cover letter containing the type of DMF, the specific content included, and contact information.
  • Administrative Information: Provide the DMF holder’s and US Agent’s contact details.
  • Technical Content: This varies depending on the type of DMF. It includes manufacturing processes, specifications, testing methods, stability data, and other technical details.
  • References and Appendices: Include all relevant references, supporting documents, and appendices.

3. Format of Document

The DMF must be prepared according to the FDA guidelines on electronic submissions using the eCTD format.

4. Compile the Submission

  • Ensure all sections are complete and properly formatted.
  • Compile the document into eCTD format.

5. Obtain a Pre-Assigned Number

Request a pre-assigned application number for DMF from the FDA.

6. Submit the DMF

Submit the DMF electronically via the FDA’s ESG portal.

7. Pay the Fee

Type II DMF Submission from an API Manufacturer for a generic drug application need to pay FDA fees. There is no FDA fee for other types of DMF submissions.

8. Acknowledge Receipt

Once submitted, FDA will acknowledge receipt of the DMF.

9. Annual Updates and DMF amendments

  • Submit annual updates and amendments as needed.
  • Keep the FDA informed of any changes to the DMF’s content or contact information.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Drug Master Files

A Drug Master File (DMF) is a confidential and detailed document submitted to the US FDA by a drug manufacturer. It contains comprehensive information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMF submission is not required by FDA regulation. DMF is solely submitted at the discretion of the DMF holder. A MDF is not approved or disapproved. Technical contents of a DMF may be reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. DMF allows FDA to review this information to ensure the quality and safety of the drug products without disclosing proprietary information to the drug product’s sponsor.

The submission of a DMF can be made by:

  1. API manufacturers
  2. Excipient manufacturers:
  3. Container Closure System manufacturers
  4. Drug Product manufacturers

Types of DMF:

  1. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (discontinued since September 2010).
  2. Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product.
  3. Type III: Packaging Material.
  4. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
  5. Type V: FDA Accepted Reference Information

Non-US DMF applicants are required to appoint a US Agent in their DMF for FDA communication purpose.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us