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Fosfomycin granules for Oral Suspension Sachet

Manufacturing Process for Fosfomycin 3g Granules for Oral Suspension at Den Mark Pharmaceuticals Pvt. Ltd. (As per WHO GMP)

Den Mark Pharmaceuticals Pvt. Ltd. manufactures high-quality Fosfomycin 3g granules for oral suspension following strict WHO Good Manufacturing Practices (GMP) guidelines with its drug manufacturing properties. This ensures consistent product quality, safety, and efficacy.

1. Starting Materials and Master Formula Record (MFR)

  • The process begins with the acquisition of approved raw materials from qualified vendors. Each material is accompanied by a certificate of analysis (CoA), ensuring compliance with specifications.
  • The MFR, a standardized document, outlines the exact quantities of each raw material, along with their in-house reference codes and batch numbers, for a single production batch.

2. Weighing and Dispensing:

  • A designated weighing area with calibrated balances ensures accurate material dispensing.
  • Following the MFR, trained personnel will weigh each raw material (Fosfomycin trometamol powder, citric acid, sodium citrate, flavoring agents, sweeteners, and excipients) and dispense them into designated labeled containers.

3. Granulation:

  • The weighed materials are transferred to a granulator, a blending machine that mixes the powders uniformly.
  • The granulation process may involve adding granulating liquids or solvents to achieve the desired granule size and ensure proper flow characteristics for packaging.

4. Drying

  • The moist granules are transferred to a tray or fluid bed dryer for drying at a controlled temperature and airflow.
  • Constant monitoring ensures complete drying to prevent microbial growth and maintain product stability.

5. Milling and Sieving:

  • The dried granules are milled into a uniform size using a grinder.
  • The milled granules are then passed through a sieve of defined mesh size to ensure consistent granule size distribution. Oversized or undersized granules are rejected and reprocessed.

6. Blending:

  • The sized granules are transferred to a blender along with any additional ingredients, such as lubricants or disintegrants, as per the MFR.
  • Blending ensures the homogenous distribution of all components throughout the batch.

7. In-Process Quality Control:

  • Throughout the manufacturing process, samples are withdrawn for in-process quality control testing.
  • This may include tests for physical characteristics (bulk density, flowability), chemical identity (Fourier-Transform Infrared Spectroscopy - FTIR), and potency (High-Performance Liquid Chromatography - HPLC).

8. Filling and Packaging:

  • The qualified granules are transferred to an automated filling machine.
  • Pre-sterilized sachets are loaded onto the machine, and each sachet is filled with the precise amount of granules per the MFR.
  • The filled sachets are then sealed, transferred to a packaging line for secondary packaging, and placed into cartons.

9. Labeling and Quarantine:

  • Each sachet and carton are labeled with the product name, batch number, manufacturing date, expiry date, dosage information, and storage instructions.
  • The labeled finished product batches are quarantined in a designated storage area awaiting release.

10. Quality Control and Release

  • Representative samples from each batch undergo final product quality control testing.
  • This includes comprehensive testing per the pre-defined specifications, covering chemical, physical, and microbiological parameters.
  • The batch is only distributed after all test results meet the acceptance criteria.

11. Documentation and Batch Records:

  • Detailed records of each production step, including raw material COAs, weighing records, process parameters, and quality control results, are maintained.
  • This comprehensive batch record ensures traceability and facilitates future investigations if necessary.

12. Warehousing and Distribution:

  • The released finished product batches are stored in the designated warehouse under appropriate conditions (temperature, humidity).
  • The product is distributed to customers through a qualified distribution network, ensuring it reaches patients promptly.

Following these strict WHO GMP guidelines, Den Mark Pharmaceuticals Pvt. Ltd. consistently produces high-quality Fosfomycin 3g granules for oral suspension, meeting all regulatory requirements and patient needs.