Visual Inspection Criteria for Capsules
1) Purpose
The purpose of this SOP is to establish criteria for accepting or rejecting capsules based on visual inspection to ensure product quality and safety.
2) Scope
This SOP applies to the visual inspection of all capsules produced in the pharmaceutical manufacturing facility before packaging and distribution.
3) Responsibilities
– Quality Control (QC) personnel are responsible for conducting the visual inspection of capsules.
– Production supervisors are responsible for ensuring that all capsules are inspected according to this SOP.
– The Quality Assurance (QA) department is responsible for reviewing inspection results and making the final decision on acceptance or rejection.
4) Procedure
1. Preparation for Inspection
1.1. Ensure that the inspection area is clean and well-lit.
1.2. Gather all necessary inspection tools and documentation forms.
1.3. Wear appropriate personal protective equipment (PPE) as per safety guidelines.
2. Inspection Criteria
2.1. Inspect capsules for any visible defects such as:
2.1.1. Cracks
2.1.2. Chips
2.1.3. Deformities
2.1.5. Foreign particles
2.2. Compare capsules against reference samples and specifications provided in the batch record.
3. Inspection Process
3.1. Randomly select a sample of capsules from each batch.
3.2. Inspect each capsule under adequate lighting and magnification, if necessary.
3.3. Record the number of defective capsules and the type of defects observed.
4. Acceptance and Rejection Criteria
4.1. Accept the batch if the number of defective capsules is within the acceptable limit defined in the quality specifications.
4.2. Reject the batch if the number of defective capsules exceeds the acceptable limit.
4.3. Document the decision and notify the production and QA departments.
5. Documentation
5.1. Complete the visual inspection form with all required details.
5.2. Sign and date the inspection form.
5.3. File the inspection form in the batch record.
5) Abbreviations, if any
– QC: Quality Control
– QA: Quality Assurance
– PPE: Personal Protective Equipment
6) Documents, if any
– Visual Inspection Form
– Batch Record
7) Reference, if any
– Regulatory guidelines as per FDA, EMA, and other relevant authorities.
8) SOP Version
Version 1.0
