[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.95]

[Page 241-242]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
  Subpart E_Requirement to Establish a Production and Process Control 
                                 System
 
Sec.  111.95  Under this subpart E, what records must you make and keep?

    (a) You must make and keep records required under this subpart E in 
accordance with subpart P of this part.
    (b) Under this subpart E, you must make and keep the following 
records:
    (1) The specifications established;
    (2) Documentation of your qualification of a supplier for the 
purpose of relying on the supplier's certificate of analysis;
    (3) Documentation for why meeting in-process specifications, in 
combination with meeting component specifications, helps ensure that the 
dietary supplement meets the specifications for identity, purity, 
strength, and composition; and for limits on those types of 
contamination that may adulterate or may lead to adulteration of the 
finished batch of the dietary supplement; and
    (4) Documentation for why the results of appropriate tests or 
examinations for the product specifications selected under Sec.  
111.75(c)(1) ensure that the dietary supplement meets all product 
specifications;

[[Page 242]]

    (5) Documentation for why any component and in-process testing, 
examination, or monitoring, and any other information, will ensure that 
a product specification that is exempted under Sec.  111.75(d) is met 
without verification through periodic testing of the finished batch, 
including documentation that the selected specifications tested or 
examined under Sec.  111.75 (c)(1) are not able to verify that the 
production and process control system is producing a dietary supplement 
that meets the exempted product specification and there is no 
scientifically valid method for testing or examining such exempted 
product specification at the finished batch stage.
    (6) Documentation of FDA's response to a petition submitted under 
Sec.  111.75(a)(1)(ii) providing for an exemption from the provisions of 
Sec.  111.75(a)(1)(i).

[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007]