QAS-017 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 322

SOP No. QAS-017.00 Effective date: mm/dd/yyyy
Approved by:

36.1 PurPose
This SOP outlines the stepwise procedure for the auditing and confirming of the fill volume and
physical characteristics of containers, closures, and the liquid products contained within them
(syrup, suspension, drops, and solutions).

36.2 resPonsibility
It is the responsibility of the QA officer and QAI to follow the procedure. The QA manager is
responsible for system compliance.

36.3 Procedure
In-process audit checks will be carried out on an hourly basis. This procedure is divided into two
portions.

A. The audit checks to be carried out for ensuring the system and process are as follows:

A.1 Equipment and area clearance checks will be done

A.2 Line release will be done

B. The audit checks to be carried out during filling operations are as follows:

B.1 Physical attributes of containers, closures, and the product

B.2 Volume checks

B.3 Removal torque checks

B.4 Leak test

A.1 Equipment and area clearance checks
A.1.1 In the first round of the area, the QAI will check the line clearance granted by the
packaging supervisor.
A.1.2 Check that all packers/operators are properly dressed and their hair are properly
covered.
A.1.3 Check that machine and capper operators are wearing masks and safety goggles.
A.1.4 Check that only one batch is filled at a time and no other batch or product is lying
in the area.
A.1.5 Check that N 2 gas flushing is done adequately in the bottles (where required).
A.1.6 Tally the product's name and batch number on line clearance with the MPI
requisition.
A.1.7 Also check for release of the bulk product by QC on the bulk release sheet, its
manufacturing and expiry dates.
A.1.8 If all of the good manufacturing practices (GMP) requirements and area clear-
ance requirements are found to be satisfactory, then allow the process to start,
and set up the machine by signing on the line clearance. If any deviation is
observed, write in the control chart along with the corrective action taken in the
remarks column.

A.2 Line release

When the machine is set and the product coming out of it is found to be as per specifications, the
packaging supervisor will inform the QAI to grant the line release.
The QAI will check the following:

1. Volume