QCS-003 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 6

SOP No. QCS-003.00 Effective date: mm/dd/yyyy
Approved by:

3.1 PurPose
To describe the procedure for the handling of bulk and intermediate products in a QC laboratory.

3.2 resPonsibility
The process staff member of the QA department and laboratory analysts are responsible to follow
the procedure. In turn, the QA and QC directors are responsible for the SOP compliance.

3.3 Procedure

3.3.1 B ulk P roductS
Bulk products are sampled by the QA inspectors. The samples are then conveyed to QC laboratory
along with the bulk release sheets (see Attachment I), also filled in by in-process quality assurance
inspectors (QAI).
In the QC laboratory, the following procedures apply:

• The sample's QC number is recorded in the bulk product analysis journal, which is main-
tained in chronological order. The tests are carried out in accordance with specifications
for finished products using analytical methods for finished products.
• If the sample complies with its speciications and the batch documents (raw material req-
uisition, in-process control results, and batch manufacturing records) are evaluated and
approved by the QC manager, then release for packaging is issued on a bulk release sheet
which is later sent to the manufacturing department.
• The batch documents, processed so far, are iled. Additional batch documents from pack-
aging operations are received after the packaging process is completed.
• If the sample does not comply with the speciications, a formal out-of-speciication (OOS)
investigation is carried out and accordingly the bulk release sheet is filled out indicating
the reasons for the noncompliance of the batch and sent back to production to be processed
further.

3.3.2 i ntermediate P roductS
Intermediate products are sampled by the QA in-process inspector. The procedure carried out is
similar to that in the case of bulk products. Release is effected by a release certificate issued by the
QC manager.

3.4 reason for revision
First time issued for your company, affiliates, and contract manufacturers.