Ambroxol HCl + Levosalbutamol Sulphate + Guaiphenesin Syrup

1. Raw Material Handling and Storage:

• Upon arrival, all incoming raw materials (Ambroxol HCl, Levosalbutamol Sulphate, Guaiphenesin, and excipients) will be inspected against specifications and certificates of analysis (CoA).
• Approved materials will be assigned lot numbers and quarantined in designated labeled storage areas under appropriate conditions (temperature, humidity).

2. Weighing and Dispensing:

• A designated area will accurately weigh each raw material according to the pre-determined bill of materials (BOM) for the desired batch size.
• Weighing balances will be calibrated regularly.

3. Syrup Preparation:

• Purified water will be prepared according to WHO specifications.
• Measured quantities of Ambroxol HCl, Levosalbutamol Sulphate, and Guaiphenesin will be added to the purified water in a suitable mixing vessel.
• Other excipients, such as sweeteners, flavourings, preservatives, and viscosity modifiers, will be added gradually under constant mixing to ensure uniformity.

4. Filtration:

• The prepared syrup will be passed through a sterile filter to remove particulate matter.
• The filter integrity will be validated before use.

5. Filling and Packaging:

• The filtered syrup will be transferred to a designated filling line.
• Pre-sterilized and dehydrogenated bottles will be filled with the accurate volume (5ml) using calibrated filling equipment.
• Filled bottles will be capped and sealed using tamper-evident closures.

6. Labelling and Coding:

• Self-adhesive labels will be applied to each bottle with the following information:
  • Product name (Ambroxol HCl + Levosalbutamol Sulphate + Guaiphenesin Syrup)
  • Strength (30mg+1mg+50mg/5ml)
  • Den Mark Pharmaceuticals Pvt. Ltd. is the manufacturer.
  • Batch number and expiry date
  • Dosage instructions and storage conditions
• Labels will comply with local regulatory requirements.
• An automated coding system will imprint a unique batch code on each bottle for traceability.

7. Quarantine and Quality Control:

• Finished product samples ( Ambroxol HCl + Levosalbutamol Sulphate + Guaiphenesin Syrup (30 mg+1 mg + 50 mg) will be collected from each batch for quality control testing.
• Testing will include physical parameters (pH, viscosity, specific gravity), chemical assays for each active ingredient, and microbiological evaluation for sterility.
• Only batches that meet all specifications will be released from quarantine for distribution.

8. Documentation and Batch Records:

• Stability studies assess the shelf-life of the syrup under different environmental conditions. Samples are stored at specified temperatures and humidity levels for predetermined periods, and periodic testing monitors any changes in quality attributes over time.

9. Documentation and Record Keeping:

• All manufacturing steps will be documented in detailed batch records.
• Records will include raw material weights, production parameters, equipment identification, and quality control results.
• Batch records will be reviewed and signed by authorized personnel before product release.

Additional Considerations for WHO GMP Compliance:

• Personnel: Qualified personnel will be trained on GMP principles and specific procedures for this product.
• Equipment: All equipment will be properly calibrated and maintained per a defined schedule.
• Validation: Manufacturing processes will be validated to ensure consistency and meet quality specifications.
• Cleaning and Sanitation: To prevent contamination, all manufacturing areas and equipment will be cleaned and sanitized according to established procedures.
• Waste Management: Waste generated during production will be disposed of according to regulations.

Conclusion:

• By following this outlined manufacturing process and adhering to WHO-GMP guidelines, Den Mark Pharmaceuticals Pvt. Ltd. a Generic Drug Manufacturer in India can ensure consistent production of high-quality Ambroxol HCl + Levosalbutamol Sulphate + Guaiphenesin Syrup (30mg+1mg+50mg/5ml) for patient use.