QAS-015 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 312

SOP No. QAS-015.00 Effective date: mm/dd/yyyy
Approved by:

34.1 PurPose
This SOP provides a procedure for the inspection of physical attributes of capsules.

34.2 resPonsibility
The QA inspector and the QA officer will be responsible for compliance. The QA manager will be
responsible for compliance of this SOP.

34.3 Procedure
After the completion of a process, QA will perform the physical inspection as per the following
procedure:
ANSI/ASQC Z1.4 level I (Annexure I) will be used to determine the sample size to be inspected
(as per batch size) as well as acceptance and rejection criteria.

a. Inspection of physical attributes to be carried out by the QAI in the humidity-controlled
manufacturing area (RH NMT 50% or as per the product's requirement).

b. The QAI should wear gloves and mask during the inspection.

c. Sampled capsules are to be spread over glass paper and under inspection lamp equipped
with manufacturing glass. The samples will be observed thoroughly for defects accord-
ing to the acceptance criteria.

Attribute's Inspection: Capsules

a. Critical defects: AQL 0.0%

1. Foreign product/odor

2. Gross foreign matter

3. Unlock capsules

4. Cut capsules

5. Incorrect color/size/shape/print

b. Major defects: AQL 1.0%

1. Dented capsule

2. Cracked/powder leakage

3. Print missing/illegible

4. Loose closure

5. Cap/body cutting into one another

c. Minor defects: AQL 2.5%

1. Dusty capsule

2. Pinholes (no leakage)

3. Print smudged

34.4 reason for revision
First time issued for the ABC Pharmaceutical Company.