Day 062 - 06 Dec 94 - Page 67


     
     1        must comply with current FDA Good Manufacturing Practices
     2        in manufacturing, processing, packing, labelling and
     3        holding McDonald's products", what is the FDA Good
     4        Manufacturing Practices?
     5        A.  That is a set of practices, guidelines, if you will,
     6        with respect to hygienic production of products, mostly
     7        used in processes of items that are either food contact or
     8        medical items or food itself.
     9
    10   Q.   What does the FDA stand for?
    11        A.  Food and Drug Association.
    12
    13   Q.   Association?
    14        A.  I think it does.
    15
    16   Q.   So is that a European thing?
    17        A.  No, that is an American.
    18
    19   Q.   That is an American thing.
    20        A.  They just issued those guidelines and since -----
    21
    22   Q.   This is a Perseco Europe Product Specification?
    23        A.  Since there is no such guideline in Europe yet and the
    24        general use in the industry, the industry standard is the
    25        GMP, Good Manufacturing Practices.
    26
    27   MR. JUSTICE BELL:  Is it "Authority" rather than an
    28        "Association"?
    29
    30   MR. MORRIS:  I would have said "Administration".
    31
    32   MR. JUSTICE BELL:  Anyway, it is the arm of the US government
    33        which is responsible for that aspect?
    34        A.  Yes, and they have issued a set of guidelines.  It is
    35        nothing more than that.  It is a set of guidelines which
    36        has been adopted by industry as a standard practice.
    37
    38   MS. STEEL:  In Europe as well?
    39        A.  And in Europe when you talk about Good Manufacturing
    40        Practices, most people know what you are talking about.
    41        That is the use of standards or standard guidelines.
    42
    43   MR. JUSTICE BELL:  It does not bind Europe but you picked it as
    44        a standard to be applied ---
    45        A.  Yes.
    46
    47   Q.   -- in want of a generalised governmental standard
    48        throughout Europe, is that what it boils down to?
    49        A.  Yes, in this country we nowadays do have a code of
    50        practice for -- it is issued by the Royal Society of Health 
    51        and it is actually a code of practice for packaging 
    52        suppliers that produce packaging that comes -- is to be 
    53        coming in contact with food.  And if I am talking to a UK
    54        supplier, I will generally refer to that document actually
    55        rather than the FDA, Good Manufacturing Practices.
    56
    57   MS. STEEL:  Is it against the law to use recycled paper in
    58        contact with food?
    59        A.  No, it is not.
    60

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