QCS-015 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 78

SOP No. QCS-015.00 Effective date: mm/dd/yyyy
Approved by:

15.1 PurPose
The purpose of this SOP is to describe the procedure for the handling of controlled substances.

15.2 resPonsibility
The in-process staff of the QA department and the QC laboratory analysts are responsible to follow
up the procedure. The QA and QC managers/supervisors are responsible for the SOP compliance.

15.3 Procedure

15.3.1 l iSt of c ontrolled S uBStanceS at the aBc P harmaceutical c omPany
Diazepam
Phenobarbitone
Di-phenoxyate HCl
Codeine phosphate

15.3.2 r aw m aterialS
i. The raw materials are sampled by the QA sampler as per quantity specified in the raw
material sampling procedure (sufficient for testing only). A blue requisition form approved
by the QA director will be forwarded to the store.
ii. The sample is marked as “CDS” material and handed over to the QA officer in the stores.
iii. The QA officer will then hand over the sample to the QC supervisor accompanied with a
receiving report.
iv. The QC supervisor (material receiving) makes sure that the materials are entered in the
materials receiving register. The samples are kept under the custody of the QC manager.
v. The QC supervisor (raw material) will hand over the material to the analyst for testing.
vi. The samples will be kept under safe custody until the analyses is completed.
vii. After completion of the test, the leftover quantity (if any) is handed over to the QC manager.
viii. The leftover quantity is destroyed by burning in a furnace at 800°C.

ix. The QC manager will then verify the destruction of the material.

15.3.3 B ulk P roductS
i. The bulk products are sampled by the QA inspector as per sampling quantity specified in
the bulk products sampling procedure (sufficient for testing only).
ii. The QA inspector will hand over the sample to the QC supervisor (material receiving).
iii. The QC supervisor (material receiving) makes sure that the materials are entered in the
materials receiving register. The samples will be kept under the the custody of the QC
manager.
iv. The QC supervisor (bulk material) will hand over the materials to the analyst for testing.
v. The sample will again be kept under safe custody until the analyses is completed.
vi. After completion of the test, the leftover quantity, if any, is handed over to the QC
manager.
vii. The leftover sample is destroyed. Solid samples are soaked in water and drained. The
liquid samples are directly drained.