QCS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 56

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

Subject: Managing Primary and Secondary Reference Standards in the Quality Control
Laboratory

12.1 PurPose
To provide and define a written procedure for the management of primary and internal working
standards (secondary) so as to ensure the appropriate use of standard in analytical work.

12.2 scoPe
Includes all primary analytical reference standards, including but not limited to compendial assay,
titrimetric, thermometric, and spectrophotometric standards. All materials are to be used as work-
ing (secondary or in-house) standards, including, but not limited to, raw materials and purchased
materials.

12.3 resPonsibility
• It is the responsibility of the authorized person/designate to follow up the procedure and to
control the reference standards. QC manager/designate will be responsible for the SOP
compliance.
• It is the responsibility of each analyst to ascertain that the particular supply of primary
reference standards in use is from the current lot.
• It is the responsibility of the QC manager/designate (raw material section) to review online
the USP Catalogue on a bimonthly basis for any change in the status of reference standards
currently in use.

12.4 Procedure

1. Primary reference standards
• Oficial standards (USP/BP/EP/JP) are required for all compendial monograph work.
These can be purchased from US pharmacopeial convention, British pharamacopeial
commission, European pharmacopeial commission, and Japanese pharmacopeia,
respectively.
• Only the current regulatory lot will be used. Current lot numbers are listed in the
catalogues or cited on the web page of each pharmacopeia.
• On receipt of a standard, the name, lot number, and date received will be entered into
a log book allocated for primary reference standards only.
• All primary standards are stored under the recommended storage conditions men-
tioned either on the vial of the standard or in the safety data sheet supplied with the
standard. The standards are then stored in a secure location to which access is limited
only to laboratory personnel having a management authority.
• A periodical inventory (on a quarterly basis) will be carried out and documented in a
log book to assure that only current lots are in the system (e.g., if current lot is “G,” it
means that lot “F” has expired unless the expiry date of the previous lot has not passed).
Out-of-date lots of standard must be destroyed.
• When a primary standard is needed for analytical work, it will be issued to the analyst
by the relevant officer. The analyst will then sign the standard and upon return, log in
the amount used and the notebook reference to actual weighings of the standard. After
use, the authorized person/designate must return the standard to its secure location.