Fusidic acid is an antibiotic that prevents germ growth. It is used to treat bacterial infections, particularly those of the skin, such as impetigo and cellulitis, and the eyes, such as conjunctivitis (red, itchy eyes). You can only get fusidic acid with a prescription.
This document outlines the manufacturing process for Fusidic Acid Ointment (2% + 0.025% + 0.1% w/w) at Den Mark Pharmaceuticals Pvt. Ltd, a leading drug manufacturing company in India ., adhering to WHO GMP guidelines.
Process:
1. Preparation:
- All personnel must wear appropriate PPE (gowns, gloves, masks, etc.).
- The manufacturing area must be cleaned and disinfected as per GMP guidelines.
- Weigh all raw materials accurately using calibrated balances in a designated weighing area.
- All materials must be quarantined and released by the Quality Control department before use.
2. Ointment Base Preparation:
- Melt the ointment base components in a sanitized ointment vessel at a temperature appropriate for the specific base formula, following validated procedures.
- Maintain gentle mixing throughout the melting process.
3. Aqueous Phase Preparation (if applicable):
- If the formulation includes an aqueous phase, dissolve preservatives and antioxidants in purified water following a validated procedure. Ensure proper mixing and heating to a designated temperature.
4. Active Pharmaceutical Ingredient (API) Dispersion:
- In a separate sanitized vessel, disperse Fusidic Acid in a suitable solvent (as per the approved formulation) using appropriate mixing equipment. Ensure uniform particle size distribution as per specifications.
5. Hydrocortisone Acetate and Clotrimazole Incorporation:
- Add the weighed quantities of Hydrocortisone Acetate and Clotrimazole to the ointment base or the API dispersion (depending on formulation) and mix thoroughly using homogenizers or other suitable equipment.
- Maintain a constant mixing speed and time as per validated procedures.
6. Aqueous Phase Incorporation (if applicable):
- If applicable, slowly incorporate the pre-heated aqueous Phase into the oil phase containing the APIs while maintaining continuous mixing. Ensure proper emulsification is achieved.
7. Deaeration:
- Apply a vacuum to the ointment to remove any entrapped air bubbles that may affect product stability.
8. Cooling and Maturation:
- Cool the Fusidic Acid Ointment (2% + 0.025% + 0.1% w/w) to a predetermined temperature under controlled conditions as per validated procedures. This allows for proper crystal formation and consistency development.
- The ointment may undergo a maturation period for further stabilization, as specified in the formulation.
9. Filling and Packaging:
- Transfer the finished Fusidic Acid Ointment (2% + 0.025% + 0.1% w/w) to pre-sterilized and labeled tubes using appropriate filling equipment.
- Ensure accurate filling weight and minimize product loss.
- Seal the tubes and apply tamper-evident seals.
10. Cleaning:
- Clean and disinfect all equipment used in the manufacturing process following validated procedures.
11. Labeling and Quarantine:
- Apply product labels with batch number, expiry date, and other mandatory information.
- Quarantine the finished product batch for Quality Control testing.
12. Quality Control:
- The Quality Control department performs a battery of tests on representative samples from the batch, including:
- Assay of Fusidic Acid, Hydrocortisone Acetate, and Clotrimazole content.
- Microbiological testing for sterility.
- Physical tests for appearance, consistency, pH, and weight uniformity.
- Container closure integrity testing.
13. Release and Storage:
- Upon successful completion of all quality control tests, the batch is released for distribution.
- Store the finished Fusidic Acid Ointment (2% + 0.025% + 0.1% w/w) under the recommended conditions (e.g., temperature, light) as specified in the product specification sheet.
Documentation:
- All stages of the manufacturing process are documented as per GMP guidelines, including:
- Batch production records
- Raw material consumption records
- Equipment calibration records
- Deviations and corrective actions (if any)