Is it required to perform Process Validation for food or dietary supplements?

v9991

Trusted Information Resource
#1
Is it required to perform perform process validation for food or dietary supplements.

Is it adequate to show the process&QC-controls and an annual review/trend for same?

Is it specified in any of the regulations?
 
Elsmar Forum Sponsor
M

maaquilino

#2
Re: Is it required to perform perform process validation for food or dietary suppleme

Is it required to perform perform process validation for food or dietary supplements.

Is it adequate to show the process&QC-controls and an annual review/trend for same?

Is it specified in any of the regulations?
From a good business practices viewpoint, if you're manufacturing anything, doing a process validation is a good idea, imo. Also, what you need to do may depend on what facet you're talking about - manufacturing, using computerized systems, sterilization, etc.

Below are some things I found on the FDA website that may help.

Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide
http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm238182.htm

PART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111

Good Manufacturing Practices (GMPs) for the 21st Century - Food Processing
http://www.fda.gov/food/guidanceregulation/cgmp/ucm110877.htm

FD&C Act Chapter IV: Food
http://www.fda.gov/RegulatoryInform...eticActFDCAct/FDCActChapterIVFood/default.htm

GMPs - Section Three: Previous Surveys of Manufacturing Practices in the Food Industry
http://www.fda.gov/food/guidanceregulation/cgmp/ucm110912.htm

Proposed Rule: Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based Preventive
Controls for Human Food
http://www.fda.gov/downloads/food/guidanceregulation/ucm345224.pdf

Center for Food Safety and Applied Nutrition (CFSAN) Plan for Program Priorities, 2013-2014
http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cfsan/whatwedo/ucm366279.htm

Computerized Systems in Food Processing Industry
http://www.fda.gov/iceci/inspections/inspectionguides/ucm074871.htm

Food CGMP Modernization ? A Focus on Food Safety
http://www.fda.gov/food/guidanceregulation/cgmp/ucm207458.htm
 

v9991

Trusted Information Resource
#3
Re: Is it required to perform perform process validation for food or dietary suppleme

From a good business practices viewpoint, if you're manufacturing anything, doing a process validation is a good idea, imo. Also, what you need to do may depend on what facet you're talking about - manufacturing, using computerized systems, sterilization, etc.

Below are some things I found on the FDA website that may help.

Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide
http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm238182.htm

PART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111

Good Manufacturing Practices (GMPs) for the 21st Century - Food Processing
http://www.fda.gov/food/guidanceregulation/cgmp/ucm110877.htm

FD&C Act Chapter IV: Food
http://www.fda.gov/RegulatoryInform...eticActFDCAct/FDCActChapterIVFood/default.htm

GMPs - Section Three: Previous Surveys of Manufacturing Practices in the Food Industry
http://www.fda.gov/food/guidanceregulation/cgmp/ucm110912.htm

Proposed Rule: Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based Preventive
Controls for Human Food
http://www.fda.gov/downloads/food/guidanceregulation/ucm345224.pdf

Center for Food Safety and Applied Nutrition (CFSAN) Plan for Program Priorities, 2013-2014
http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cfsan/whatwedo/ucm366279.htm

Computerized Systems in Food Processing Industry
http://www.fda.gov/iceci/inspections/inspectionguides/ucm074871.htm

Food CGMP Modernization ? A Focus on Food Safety
http://www.fda.gov/food/guidanceregulation/cgmp/ucm207458.htm
I agree with the line that it makes a very good business sense, and i have also referred some of the above documents. (especially the survey )

However, to put it across to business/management, the explicit reference of a guideline/regulation is always handy,
any my query is about the manufacturing process validation.

thank you.
 

Ajit Basrur

Staff member
Admin
#4
Re: Is it required to perform perform process validation for food or dietary suppleme

You can refer this document - USP Dietary Ingredient Verification Program.

http://www.usp.org/sites/default/files/usp_pdf/EN/USPVerified/divpparticipantguidelines.pdf

Participation is voluntary and open to participants manufacturing dietary ingredients for use in dietary supplements and other finished products. USP uses US definitions of dietary ingredients to include vitamins, minerals, amino acids, botanical extracts and non-botanicals, and other non-botanical substances that are used in the manufacture of dietary supplement
products.

There are several references to the Process Validation and some examples are -

Process Validation (on page 14)
Demonstrated for dietary ingredients submitted to the Program for verification.

Manufacturing Process Validation (on page 19) :
USP will review the developmental history of the manufacturing process and process validation studies for the dietary ingredient.

References of the Process Validation can also be seen in the section "On-site Audit checklist".
 

Attachments

M

maaquilino

#5
Re: Is it required to perform perform process validation for food or dietary suppleme

Many times there isn't an explicit regulation spelled out as management might like to see it, but there can be a mention in a guideline of something that 'should' be done; and in my experiences with FDA inspections, when an inspector comes in they look for those things mentioned in the guidelines to be done; and many times they have successfully tied them to a regulation. The last company I worked for did medical devices/pharma/surgical, but their pharma division also did supplements, and we did nothing different when manufacturing them than we did for the rest of the products we made, and that included doing a process validation of the system.

With all that goes into manufacturing food and ensuring its safety, how can that be done without verifying or validating that the process to do those things works the way it should? And if computer systems are used in the manufacture, those do need to be validated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=110.80

http://www.fda.gov/iceci/inspections/inspectionguides/ucm074871.htm
See references section also
 
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