QCS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 58

SOP No. QCS-012.00 Effective date: mm/dd/yyyy
Approved by:
1. Define the tests and specifications that are required to evaluate the suitability of the
material as an internal working standard. As a minimum, the following tests will be
performed:
a. Description
b. Identification (by more than one specific method)
c. Moisture
d. Purity or potency (any other applicable purity test impurities, degradation products)
e. Any other applicable stability indication tests
2. The potency of each sample lot will be tested on “as is basis” in triplicate, on two separate
days, and preferably by the same analyst, which means a total of six tests per sample is
required.
3. Evaluate statistically the results for potency/purity as per ABC Pharmaceutical Company's
standard control procedures. If the individual results are valid, calculate the average value
and assign the average potency/purity to the material.
Note : The potency/purity value obtained must be statistically comparable to data shown in
the supplier's certificate of analysis.
a. Review the data to confirm that the material is suitable, assign the potency/purity value
determined by the assays, and designate the material as an internal working standard.
b. Issue a signed and dated certificate of analysis for this internal working standard.
c. Keep all documentation, data safety precautions, and test results in a file designated
as part of the internal working standard program for review or use by an authorized
personnel.
d. Assign a 1-year expiry date to internal working standards. At the end of the expiry period,
any quantity remaining of the lot must be discarded. On an exceptional basis, some sec-
ondary reference standards may be recertified for an additional 1 year period. The stan-
dards must not be used beyond 2 years from the original date of certification.
e. The reason for assigning 1 year expiry date for the secondary reference standards is the
fact that the internal working standard maximum of 2 g/vial is standardized at a time and
the frequency of usage ensures that the standard does not exist beyond 1 year. Besides this,
the history of the material also shows from manufacturing suppliers certificate that they
are stable for a period of up to 3-4 years which also supports the validity of these second-
ary standards for 1 year under controlled temperature.
f. Review the data to confirm that the material is suitable, assign the potency/purity value
determined by the assays, and designate the material as an internal working standard (sec-
ondary reference standard).
12.5.3 S uBdiviSion and l laBeling
When the certification of the internal working standard is completed, it should be subdivided into
small quantities, not exceeding 2 g/vial (for moisture-sensitive material, it should not exceed
200 mg/vial). The container should be of amber glass or plastic (if compatible with the material),
clean and dry, with dry, hermetic closures, and the subdivision should be performed by trained per-
sonnel under controlled conditions. Each vial should be labeled to show: