QCS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 59

SOP No. QCS-012.00 Effective date: mm/dd/yyyy
Approved by:

Internal working standard:

1. Material name

2. Assay (as is basis)

3. Lot numbers

4. Expiry date

5. Storage condition, if any

12.5.4 e xPiry d ate
The expiry date of the internal working standards on the vial/s label is mentioned as MM/YYYY,
which means that the standard can be used till the end of the month of the corresponding year. For
example, if the expiry date is given 07/2013, this would mean that the standard can be used till July
31, 2013 and will be considered expired on August 01, 2013.
The authorized person/designate will conduct an inspection at the end of each month to check
any expired standard. The expired standard will be removed immediately and documented in the
log book.

12.5.5 S torage c onditionS
Unless otherwise indicated, internal working standards must be stored in a cool and dry place away
from heat and protected from light. Some reference standards may be required to be placed in indi-
vidual plastic bags inside a desiccator placed in a refrigerator.

12.5.6 u Sage

1. Internal working standards will be used for the testing of routine production batches when-
ever the methodology calls for the use of a “reference standard.”

2. Calculations will take into consideration the labeled potency/purity of the internal
standard.

3. In some special cases, for example, to resolve analytical discrepancies, a primary reference
standard can also be used. Internal working standards cannot be used to standardize other
internal working standards. Only primary standards will be used for this purpose.

Note :

• The handling of primary and secondary reference standards will be maintained through a
register. The standards for new raw materials will be added in the register on an ongoing
basis.
• Only suficient quantity of primary standards will be purchased and long-term storage
should be avoided.
• Secondary reference standards which are stored under nitrogen will be used only once and
the remaining quantity will be discarded.
• Quantity in each vial for other secondary reference standards should be suficient for being
used three times and it should be discarded afterward.
• Primary reference standards, including controlled drug substances, will be destroyed
according to the SOP for destruction (disposal) of samples after complete testing.