Standard Operating Procedure (SOP)

Here’s a detailed Standard Operating Procedure (SOP) for the Instrument for Macroscopical Examination, used to visually inspect pharmaceutical products (such as tablets, capsules, and other dosage forms) for defects and irregularities. This ensures that products meet visual quality standards before they are released for further processing or packaging.

1.0 Objective

To define the procedure for using instruments to conduct a macroscopical examination of pharmaceutical products to ensure they meet quality standards for appearance, size, shape, and other visual characteristics.

2.0 Scope

This SOP applies to the instrumental examination of all pharmaceutical products (tablets, capsules, pellets, etc.) for macroscopical characteristics in the Quality Control (QC) laboratory at [Company Name].

3.0 Responsibility

4.0 Definitions

• Macroscopical Examination: Visual inspection of products without the use of magnification, or with low magnification, to check for defects, surface quality, size, shape, and other characteristics.

• Instrumental Examination: Use of instruments like a macro camera system or visual inspection machine to automate and standardize the examination of visual characteristics.

5.0 Materials and Equipment Required

• Macro Camera System or Visual Inspection Machine

• Light Source: LED or halogen lighting for proper illumination

• Caliper or Micrometer: For measuring size and dimensions

• Examination Tray: For placing the sample under the instrument

• Computer System (if applicable for automated systems)

• Recording Sheets or Software for documenting results

• PPE: Gloves, lab coat, safety glasses (if needed)

6.0 Procedure

6.1 Setup of Instrument

1. Ensure the macro camera system or visual inspection machine is properly calibrated as per the manufacturer’s instructions.

2. Ensure the light source is clean and provides uniform, bright illumination across the entire inspection surface.

3. Clean the examination tray or platform where the product will be placed.

6.2 Macroscopical Examination

1. Place the sample(s) on the examination tray or platform.

2. Adjust the lighting for optimal visibility of the product’s surface characteristics.

3. Initiate the inspection process by:

   • Manual Examination (if using a camera system): Inspect the product by visually evaluating it for defects, including:

     • Shape (round, oval, etc.)

     • Size (uniformity, any irregularities)

     • Color (fading, discoloration)

     • Surface (cracks, chips, roughness, scratches)

     • Weight consistency (if necessary)

   • Automated Inspection (if using a visual inspection machine): Ensure the system’s software is set to detect defects (e.g., shape, color, cracks).

4. For automated systems, the software should generate a report automatically, noting defects and the number of passed/rejected products.

5. If manual inspection is being performed, use tools such as calipers or micrometers to measure product dimensions (e.g., diameter, thickness, etc.).

6. Record any defects or irregularities in the Macroscopical Examination Log.

7. For failed products, document the reason for failure and separate the defective items for further investigation or rejection.

6.3 Documentation

1. Document the examination in the Macroscopical Examination Log or directly in the system.

2. Record the following:

   • Date and time of inspection

   • Product name or batch number

   • Number of units examined

   • Number of defective units and the type of defects (if applicable)

   • Name of the operator and supervisor’s signature

   • Any corrective action taken (if defects are found)

7.0 Frequency of Examination

• Per batch or production lot as required by specifications or quality control plan.

• During routine quality checks based on production requirements.

8.0 Acceptance Criteria

• Uniform Size and Shape: All products must meet the size, shape, and other physical specifications outlined in the Product Specification Sheet.

• No Visible Defects: Products must be free from cracks, chips, discoloration, or any other surface defects that affect the product’s integrity.

• Weight Consistency: Weight should fall within specified tolerances for each unit.

9.0 Safety and Precautions

• Always wear PPE (gloves, lab coat) during examination to avoid contamination.

• Ensure the workstation and instruments are clean and well-maintained before use.

• Handle products carefully to prevent damage during the examination process.

• Follow the manufacturer’s maintenance and calibration schedules for instruments.

10.0 Documentation and Record Keeping

• Macroscopical Examination Log: Record all inspection results, including any defects or issues found.

• Deviation Reports: If defects are found, document deviations and initiate corrective actions as required.

• Calibration Records: Ensure all instruments are regularly calibrated according to the standard operating procedure.

11.0 Abbreviations

• SOP: Standard Operating Procedure

• QC: Quality Control

• PPE: Personal Protective Equipment

• BMR: Batch Manufacturing Record

12.0 Annexures

• Annexure 1: Macroscopical Examination Log Template

• Annexure 2: Product Specification Sheet

• Annexure 3: Instrument Calibration Checklist

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