QAS-016 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 317

SOP No. QAS-016.00 Effective date: mm/dd/yyyy
Approved by:

2.3.4 Check whether the operator is wearing mask, gloves, and cap, and whether hairs
are properly covered.

2.3.5 Tally the product name and batch number on the area/equipment with the master
manufacturing formula, requisition, and powder drums.

2.3.6 Check that the capsule-filling cubical door is closed to avoid cross-contamination.

Start-up check to allow the process to run
The QAI will:

• Collect three sets of 10 empty capsules, (representative of the empty capsule to be used in
the batch) to calculate the average net weight of the empty capsules. In case of use of a
tablet testing system, enter the gross weight of the capsule, that is, the weight of empty shell
along with the net weight of powder to be filled in each capsule, when setting up a
magazine.
• Calculate the target weight (net weight of powder + empty shell weight) and limits, and
will enter it on the control chart for capsule filling.
• Conirm that the machine has been set in the preset limits by the production operator.
• Check the physical attributes of illed capsules (locked, shiny not dusty).
• Check the disintegration time prior to giving release.
• If found within the speciication, allow the process to run by giving the area release label.
• Send the assay sample to the QC laboratory from 10-20 capsules.

Checks during capsule filling operation
Weight variation checks

1.1 Initially, the machine will be set by the machine operator as per the written procedure.

1.2 Action limit

i. Once the machine has been set in its preset limit and the process is allowed to run, col-
lect samples from the machine every hour.

ii. Randomly collect 10 capsules and check their average and individual weights on the
balance for correct weight checks. (In the case of using a tablet testing system for cap-
sule weight variation, attach the printed report along with the control chart.)

iii. Record the results on the control chart.

iv. Decide the disposition as follows:

a. Adjust if

ii. X crosses ±3% from the theoretical weight

OR

ii. Two capsules cross ±5% from the theoretical weight

OR

iii. One capsule crosses ±7.5% from the theoretical weight

b. Adjust, separate, and check as per the laboratory procedure and the limits for disposition
decision of the capsule since the last check:

ii. If more than one capsule cross ±7.5% from the theoretical weight

OR

ii. If one capsule crosses ±10% from the theoretical weight