SOP for Analytical Procedure of Appearance in Vaccine Manufacturing

Purpose

To describe the procedure for the appearance test of Drug Substance and Drug Product and to standardize the assay to endure the reliability of test result.

Scope

This SOP applies to the production of Raw materials, Drug Substances, and Drug Products.

This SOP applies to Pharmaceutical Water (Purified Water, Water for Injection)

Roles and Responsibilities

• Analysts should be trained with this procedure to perform the test accurately.
• Analyst must conduct the assay following this SOP and is responsible to report the results to the QC Manager.
• In case of deviation, the analyst should report it to the QC manager and follow the SOP for "Handling of Deviations" and "Out of Specification".
• The QC manager is responsible for giving necessary instructions and assessing the adequacy of test results.

Materials and Equipment

Colorless test tube(inside diameter 15mm)

Appearance plate: consists of white and black background plate

Camera

Definitions

Appearance: Characters of the sample are determined by a sensory test like a sample color, turbidity, odor, taste, particle size, or phase (crystal, powder, granules, sticky fluid, colorless liquid, etc.) prescribed in Pharmacopeia or test procedure. However, if the analyst's health is affected by odor or taste, it must be excluded from the test items.

White and colorless: "White" means white or partially white, and "colorless" means colorless or almost colorless in the appearance test.

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Procedures

Observed

1. Color test: 

• In case of color test, take 1g of powder & solid drug and observe above the white plate.
• A liquid drug or pharmaceutical water (purified water, water for injection) is put into a colorless test tube of 15mm inside diameter and is observed in front of a white background through a layer of 30mm.
• At the test of liquid turbidity, conduct the same manner as above and use a white or black plate (A black background is used when observing fluorescence).

2. Solubility

In case of solubility test of solid, make to the form of powder and then shake for 30 seconds every 5 minutes at the 20±5°C, and observe within 30 minutes.

Descriptive Terms	Relative Amounts of Solvent to Dissolve 1 Part of Solute
Very soluble	Less than 1
Freely soluble	From 1–10
Soluble	From 10–30
Sparingly soluble	From 30–100
Slightly soluble	From 100–1000
Very slightly soluble	From 1000–10,000
Insoluble or practically insoluble	More than 10,000

3. Visual observation

• If the label is attached to the primary container(clear glass vial) surface, bags, and bottles, remove the label and observe the sample as it is in the container or test it following. Shake the sample carefully whenever it is required.
• However, for OCV products, after observing the primary container, the sample is observed in a colorless test tube with an inside diameter of 15mm, with a liquid layer of 30mm, using a white appearance plate according to above.
• Labels containing test name, lot number, sample number, test date, and tester information are attached, and the results are recorded using the camera.
• Results are managed in a folder format "Camera> equipment number> month > year_month_date > test name > lot number (sample number), photographer".]

4. Judgement

• Apply the specification criteria in each product and write the criteria on the test report form and test results write on the test form.
• Write the test report form for the test result of pharmaceutical water (purified water, water in injection).
• Write the test report form for the test result of OCV.
• Write the test report form for the test result

Related Forms

Test report form of Appearance test

Test report form of Pharmaceutical Water Appearance test

Test report form of OCV Appearance test

Test report form of Euvichol-S Appearance test

Revision History

Nil

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