Systems Processing Integration
DEFINING REGULATORY COMPLIANCE!
Natural Remedies - Dietary Supplements
Medical Foods - Beverages - Cosmetics
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"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
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.
INSTITUTIONAL REVIEW BOARD (IRB) PROTOCOL SERVICES
An allied service which can further support product claim substantiation is the Institute for Health Research's IRB service for clinical trials.
A clinical trial is the best evidence supporting claims, but the trial must start with a formal Protocol that meets IRB (Institutional Review Board) Informed Consent standards, or the results may not be eligible for publication and may be rejected as substantiation.
In collaboration with the Institute, SPI Associates provides assistance in preparing a clinical trial Protocol which will comply with IRB standards, designing the trial with the Principle Investigator (PI).
Unless you ask the right questions at the start the clinical trial will most likely not provide the data you need for legal substantiation.
For more about IRB services go to http://www.InHeRe.org and search the IRB drop-down tab.