QAS-016 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 316

SOP No. QAS-016.00 Effective date: mm/dd/yyyy
Approved by:
Subject: Introduction to Validation
35.1 PurPose
This SOP outlines the procedure for correct in-process audit checks of variable and physical char-
acteristics during encapsulation and its requirements.
35.2 resPonsibility
The area QAI is responsible for carrying out the checks and the QA manager should ensure that the
system is followed.
35.3 Procedure
Area and equipment clearance checks
1. Temperature and humidity
2. Equipment and area clearance
Equipment and area release
1. Start-up check to allow the process to run
During capsule-filling operation
The QAI will take checks every hour and confirm the following:
1. Weight variation
2. Disintegration test (where applicable) twice per shift
3. Lock
4. Length
5. Physical attributes
1. Temperature and humidity checks
1.1 Check and confirm the RH and temperature during the operation as per the written
procedure and the requirement of the area and the product.
1.2 Record the RH and temperature on the control chart. Any deviation observed should
be written in the remarks column of the control chart.
2. Equipment and area clearance checks
2.1 Check and confirm the equipment and area clearance given by the production supervi-
sor as per the written procedure.
2.2 Any deviation observed and corrective action taken should be written in the remarks
column of the control chart.
2.3 Procedure
2.3.1 Check the area, equipments, and machine for general cleanliness.
2.3.2 Check the cleanliness of the containers in which powders are kept as well as the
ones in which capsules will be kept.
2.3.3 Check proper labeling on the bulk containers in which granules/powders and
capsules are kept.