Current through Register Vol. 50, No. 12, December 20, 2024
A. All components and other materials used in
the manufacture, processing and packing of drug products, and materials
necessary for building and equipment maintenance, shall upon receipt be stored
and handled in a safe, sanitary and orderly manner to assure safety, purity and
strength. Precautions shall be taken to prevent mix-ups and cross-contamination
affecting drugs and drug products. Components shall be held from use until they
have been identified, sampled and tested for conformance to established
specifications and are released by a material approval unit. Controls of
components shall include the following.
1.
[formerly paragraph 6:202-1] Each container of component shall be examined
visually for damage or contamination prior to use, including examination for
breakage of seals, when indicated.
2. [formerly paragraph 6:202-2 ] Samples
shall be taken from component containers from each lot and shall be subjected
to one or more tests to establish their specific identity.
3. [formerly paragraph 6:202-3] Samples of
components liable to contamination with filth, insect infestation or other
extraneous contaminants shall be appropriately examined.
4. [formerly paragraph 6:202-4] Samples of
components liable to microbiological contamination shall be subjected to
microbiological test prior to use. Such components shall not contain
microorganisms that are objectionable in view of their intended use.
5. [formerly paragraph 6:202-5] Samples of
all components intended for use as active ingredients shall be tested to
determine their strength in order to assure conformance with specifications
approved by the state health officer.
6. [formerly paragraph 6:202-6] Components
which have previously been approved shall be identified and retested as
necessary to assure that they continue to meet specifications:
a. [formerly paragraph 6:202-6 (1)]
Components which have been approved shall be handled and stored to guard
against contamination or being contaminated by other drugs or
components.
b. [formerly paragraph
6:202-6 (2)] Components which have been approved shall be rotated in such a
manner that the oldest stock is used first.
c. [formerly paragraph 6:202-6 (3)] Rejected
components shall be identified and held to preclude their use in manufacturing
or processing procedures for which they are unsuitable.
7. [formerly paragraph 6:202-7] Records shall
be maintained for at least two years after distribution has been completed, or
one year after the drug's expiration date, whichever is longer. Such records
shall include:
a. [formerly paragraph 6:202-7
(1)] the identity and quantity of the component, the name of the supplier, the
supplier's lot number and the date of receipt;
b. [formerly paragraph 6:202-7 (2)]
examinations and tests performed, and rejected components and their
disposition;
c. [formerly paragraph
6:202-7 (3)] an individual inventory and record for each component used in each
batch of drug manufactured or processed.
8. [formerly paragraph 6:202-8] An identified
reserve sample of all active ingredients consisting of at least twice the
quantity necessary for all required tests, except those for sterility and
determination of pyrogens, shall be retained for at least two years after
distribution of the last drug lot incorporating the component has been
completed, or one year after the expiration date of this last drug lot,
whichever is longer.
AUTHORITY NOTE:
Promulgated in accordance with the provisions of
R.S.
40:4(A)(1)(a). Also see
R.S. 40:601 et
seq.
