QCS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 4

SOP No. QCS-002.00 Effective date: mm/dd/yyyy
Approved by:

2.1 PurPose
To describe the control of incoming materials used in production.

2.2 resPonsibility
Quality control analysts are responsible to follow the procedure. The QC manager is responsible for
the SOP compliance.

2.3 Procedure

2.3.1 S torage P rior to S amPling
All coded raw and packaging materials received are kept in an expedition area to be sampled by
QA before being transferred to the quarantine area. The sampling will be done in accordance with
sampling instructions.

2.3.2 o verview of S amPling and r ePorting P rocedureS
Inside the QC department the following procedures apply:

• All raw and packaging material samples are received at the sample receiving ofice in the
QC department. The samples are verified against their respective documents, assigned a
QC number, and sample details are entered in the respective sample registers as well
through computer programs. These samples and documents are then distributed to various
designated sections for further analyses.
• The samples are then tested in accordance with the approved speciications using speciic
test methods.
• The results are published in analytical reports designed for raw and packaging materials.
• The results are recorded in the raw material analysis journals maintained in chronological
order. The same procedure applies for the packaging materials as well.
• If the material does not comply with the speciications, proper investigations are carried
out as per the corresponding SOP, and after the investigation is completed, an analytical
report is issued indicating the reason for the rejection of the lot.

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