QAS-026 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 392

SOP No. QAS-026.00 Effective date: mm/dd/yyyy
Approved by:

Subject: Physical Characteristics Check of Product and Foil during Sealing

45.1 PurPose
To ensure that the characteristic attributes of product and foil meet the acceptance criteria.

45.2 resPonsibility
It is the responsibility of the QAI to follow the procedure. The QA systems and inspection manager
is responsible for the SOP compliance.

45.3 checks during sealing oPeration

45.3.1 a ttriButeS of P roduct and f oil c heckS

1. Check the strips/blisters coming out from the machine on an hourly basis for physical
attributes.

2. In blister machines, check tablets/capsules in the hopper/on the disk/on the conveyor for
physical attributes. If any broken, chipped, or other defective tablets/capsules are found in
the hopper/disk or conveyor, inform the operator and packaging manager and ask to sort
out the defective tablets/capsules. Also, visually inspect the tablets in the machine chan-
nels for broken, chipped, or spotted tablets.

3. Collect 10 strips/blisters from the machine during sealing for attribute checks. Check for
the following:

i. Proper cutting

ii. Proper overlapping of printed aluminum foil and plain PVC foil in strips/blisters

iii. Wrinkle punctures

iv. False sealing (open)

v. Broken capsules/tablets in each pocket

viii. Double tablets in each pocket

viii. Clearly visible channels or cut on pocket borders

viii. Misprint on the printed side of strips/blisters

ix. Correct counts

x. Check manufacturing date, expiry date, and batch number for correctness and legible

overprinting

xi. Empty pocket

4. For empty pockets, collect samples randomly from the lot stripped/blistered during last 2
hours as per the plan attached (Single Sampling, Tighten inspection Mil-Std 105E Level 1.
Table II-B; Annexure II).

5. Check each strip/blister pocket visually and decide the disposition as per attached accep-
tance plan (Annexure I) based on Mil-Std 105E (Color/opaque PVC).

6. If the lot fails, ask for 100% inspection and collect the samples again randomly from the
lot inspected and decide the disposition as per the acceptance plan.

7. After completion of the batch, randomly collect samples from the complete lot and check for
the empty pockets and decide disposition as per the attached acceptance plan (Annexure I).

8. If the lot fails then inform the packaging manager for 100% inspection.

9. After 100% inspection, collect samples as per the attached sampling plan (Annexure I) and
decide the disposition.