N.M. Admin. Code § 16.19.9.8 - MINIMUM STANDARDS
A. The
following minimum standards shall apply to all manufacturing establishments and
repackaging firms for which licenses have been issued by the Board:
(1) All drugs and chemicals used in the
manufacturing process or held for sale shall conform to the New Mexico Drug and
Cosmetic Act and shall be stored, preserved and disposed of as prescribed by
laws regulating the labeling and manufacture of drugs. When necessary, and/or
according to label requirements, all drugs and chemicals which require
refrigeration shall be stored and preserved under proper temperature.
(2) All manufacturers must conform to current
good manufacturing practices as set forth in Title 21, CFR, Subsection 211.1 to
211.208 inclusive. The definitions and interpretations contained in Section 201
of the Federal Food and Drug Act shall be applicable.
(3) All manufacturers must conform to (1141)
Packaging, Storage, and Distribution of Pharmacopeial Articles, the United
States Pharmacopeia. These include the following stability protocols:
(4) Stability of manufactured dosage forms
must be demonstrated by the manufacturer by the use if the methods adequate for
the purpose. Monograph assays may be used for stability testing if they are
stability-indicating (i.e., if they accurately differentiate between the intact
drug molecules and their degradation products). Stability considerations should
include not only the specific compendial requirements, but also changes in
physical appearance of the product that would warn, users that the product's
continued integrity is questionable.
(5) Stability studies on active substances
and packaged dosage forms must be conducted by means of "real time", long-term
tests at specific temperatures and relative humidities representing storage and
shipping conditions experienced in the distribution chain of the climatic zones
of the country or region of the world concerned. Labeling of the packaged
active substance or dosage form shall reflect the effects of temperature,
relative humidity, air, and light on its stability. Label temperature storage
warnings will reflect both the results of the real-time storage tests and also
allow for expected seasonal excursions of temperature during
distribution.
(6) All persons in
the distribution or dispensing chain shall comply with the manufacturers
directions.
B.
RADIOACTIVE PHARMACEUTICALS
(1) Radioactive
pharmaceuticals require specialized techniques in their handling and testing in
order that correct results may be obtained and hazards to personnel be
minimized.
(2) The following
minimum requirements must be met for a manufacturing establishment preparing
radiopharmaceutical products. These requirements are in addition to the
regulatory requirements of the Federal Atomic Energy Commission, the Federal
Food and Drug Administration, the U.S. Public Health Service regulations and
the New Mexico Radiation Protection Act administered by the Environmental
Improvement Agency. Minimum equipment and accessory standards:
(a) Fume hood - minimum of 30
inches
(b) Laminar flow
hood
(c) Dose calibrator
(d) Refrigerator (lead lined)
(e) Mettler balance
(f) Spectrophotometer
(g) Drawing Station (lead glass and
lead)
(3) Glassware:
(a) 3 beakers 50 ml
(b) 3 beakers 150 ml
(c) 1 beaker 500 ml
(d) 2 volumetric flasks 50 ml
(e) 6 volumetric flasks 100 ml
(f) 2 graduated cylinders 10 ml
(g) 2 graduated cylinders 100 ml
(4) Radiochromatographic strip
scanner and/or well counter
(5)
Supplies:
(a) disposable syringes 1,3 and 5
cc
(b) multidose vials 10, 20 and
30 cc
(c) disposable alcohol
swabs
(d) disposable
gloves
(6) Reference
books:
(a) American Hospital Formulary
Service
(b) National
Formulary
(c) United States
Pharmacopoeia
(7) Space:
The radiopharmaceutical manufacturing or preparation area shall be an undivided
area of not less than 240 square feet for the hot lab and storage area. The
area shall contain adequate sink with hot and cold water facilities.
Notes
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