© 2018 by Ralph Fucetola JD.
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Systems Processing Integration

Providing Specialist Support to Your Organization and its integrated Standard Operating Procedures [SOPs], Operating Procedures Systems [OPS], Mission and Branding Policies.

 

We develop and maintain a private, password protected, OPS for SOPs web site for your Company.  Just when you need access to your documentation the most urgently [for example, during a storm or an FDA inspection] you will be very happy your Company worked with Systems Processing Integration to establish your Private Site.

This web site is a project of The Vitamin Consultancy - www.VitaminConsultancy.com

Over 48 Years in the Natural Products Industry
"Is Your Paperwork in Order?"

FDA says: The Label-Owner must be "in a state of control"
Over the entire production and marketing process.

 

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
     
PART 111    CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PACKAGING, LABELING, OR HOLDING
OPERATIONS FOR DIETARY SUPPLEMENTS

 
Subpart E--Requirement to Establish a Production and Process Control System
[Excerpts]

Sec. 111.55 What are the requirements to implement a production and process control system?

You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Sec. 111.60 What are the design requirements for the production and process control system?

(a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and

(b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel.

Sec. 111.65 What are the requirements for quality control operations?

You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=111&showFR=1&subpartNode=21:2.0.1.1.11.5

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