NAC585.450. Provisions for control of quality.

The licensee shall provide for:

     1. The establishment of master records, when needed, containing specifications and a description of sampling and testing procedures for in-process drug preparation. The samples must be adequately representative and properly identified.

     2. The establishment of master records containing a description of sampling procedures and appropriate specifications for finished drugs. The samples must be adequately representative and properly identified.

     3. Adequate provisions for checking the identity and strength of drugs for all active ingredients and for ensuring:

     (a) Sterility of drugs purported to be sterile and freedom from objectionable microorganisms for those drugs which should be so because of their intended use;

     (b) The absence of pyrogens for those drugs purported to be free of pyrogens;

     (c) Not more than minimal contamination of ophthalmic ointments by foreign particles and harsh or abrasive substances; and

     (d) The pattern of drug release in products designed for a sustained release is tested by laboratory methods to ensure conformance to specifications for the release.

     4. Adequate provision for auditing the reliability, accuracy, precision and performance of laboratory test procedures and laboratory instruments used.

     5. A properly identified reserve sample of the finished product. The sample must be stored in the same immediate container and closure system in which the drug is marketed. The sample must consist of at least twice the quantity necessary to perform all the required tests except those for sterility and determination of the absence of pyrogens. The sample must be stored under conditions consistent with the labeling of the product. The licensee shall retain the sample for at least 2 years after the distribution of the drug is completed or at least 1 year after the expiration date of the drug, whichever period is longer.

     6. A provision for retaining complete records of all laboratory data relating to each batch or lot of drug. A licensee shall retain such records for at least 2 years after the distribution is completed or 1 year after the expiration date of the drug, whichever period is longer.

     7. A provision that animals must be maintained and controlled in a manner that ensures their suitability for their intended use. The licensee shall maintain appropriate records identifying the animals and providing a history of their use.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.5.4-4.5.10.1, eff. 5-15-78]