Inspection Procedures for Empty Capsule Shells

1) Purpose

The purpose of this SOP is to define the procedure for visually inspecting empty capsule shells for defects, such as cracks or deformities, to ensure only quality shells are used for filling.

2) Scope

This SOP applies to all empty capsule shells received and used within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting the visual inspection of empty capsule shells.
– Warehouse personnel must notify QC of incoming capsule shell deliveries.
– QA personnel are responsible for reviewing and approving the inspection results.

4) Procedure

1. Preparation for Inspection
1.1. Ensure that the inspection area is clean, well-lit, and free from contaminants.
1.2. Gather necessary inspection tools, such as magnifying glasses and tweezers.
1.3. Wear appropriate personal protective equipment (PPE) as per safety guidelines.
2. Receiving Capsule Shells
2.1. Upon arrival, verify that the capsule shell containers are properly labeled with the supplier name, material type, batch number, and other relevant information.
2.2. Inspect the condition of the containers for any signs of damage or tampering.
3. Visual Inspection Criteria
3.1. Open the containers and inspect the capsule shells for:
3.1.1. Cracks or fractures
3.1.2. Deformities or irregular shapes
3.1.3. Discoloration or stains
3.1.4. Foreign particles or contamination
3.2. Use a magnifying glass if necessary to detect small defects.
4. Documentation
4.1. Record the results of the inspection on the capsule shell inspection form.
4.2. Include details such as batch number, supplier name, date of inspection, and any observations or anomalies.
4.3. Sign and date the inspection form.
5. Acceptance and Rejection
5.1. Accept the capsule shells if they meet all specified criteria.
5.2. Reject the capsule shells if they show signs of defects or contamination.
5.3. Notify the supplier of any rejected materials and document the rejection.
6. Storage of Accepted Materials
6.1. Store accepted capsule shells in designated storage areas under appropriate conditions to prevent damage or contamination.
6.2. Ensure that all storage areas are labeled and organized to prevent mix-ups.
7. Corrective Actions
7.1. If capsule shells are rejected, initiate a corrective action report.
7.2. Document all actions taken to address issues identified during the inspection.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– PPE: Personal Protective Equipment

6) Documents, if any

– Capsule Shell Inspection Form
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– USP <1066> Physical Environments that Promote Safe Medication Use

8) SOP Version

Version 1.0