The antibiotic Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) is a lincomycin antibiotic class member, which inhibits or halts bacterial growth. It is not recommended to use Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) orally, ophthalmically, or intravaginally. It is only intended for topical application. If you are allergic to the lincomycin class of antibiotics or have susceptible skin, you should avoid using a Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w). Applying Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) to areas of skin that are wounded, scraped, sunburned, or eczema-affected is not advised.
Den Mark Pharmaceuticals Pvt. Ltd. manufactures Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) following the World Health Organization (WHO) Good Manufacturing Practices (GMP) guidelines with all the drug development services. This ensures a high-quality, consistent, and safe product.
Process Flow
1. Raw Material Handling and Testing:
- All incoming raw materials (Clindamycin Phosphate, Nicotinamide, gel base components, purified water) are quarantined upon arrival.
- Accompanied by certificates of analysis, ensuring they meet Den Mark's specifications.
- Samples are tested internally to verify their identity, purity, and potency.
- Only released materials are used for production.
2. Weighing and Mixing:
- A designated weighing area, following GMP guidelines, is used.
- Accurately weighed amounts of Clindamycin Phosphate and Nicotinamide are dispensed according to a pre-determined master formula.
- The gel base components are measured and added to a mixing vessel.
3. Dissolution and Homogenization:
- Clindamycin Phosphate and Nicotinamide are dissolved in a suitable solvent within the mixing vessel.
- The mixture is homogenized using a high-shear mixer to ensure uniform distribution of the active ingredients throughout the gel base.
4. Filling and Packaging:
- Using appropriate filling equipment, the gel is filled into pre-sterilized and validated containers under aseptic conditions.
- Containers are sealed with tamper-evident closures.
- Labels are applied according to product specifications.
5. Quality Control:
- Samples of Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) from each batch are retained for further testing.
- These tests evaluate physical characteristics (pH, viscosity), uniformity of dosage units, and sterility.
- The final Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) is released for packaging only after all quality control tests are met.
6. Packaging and Labeling:
- Packaged Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) are labeled according to regulatory requirements.
- Labels include product names, ingredients, concentrations, manufacturing and expiry dates, batch numbers, storage instructions, and manufacturer information.
7. Quarantine and Release:
- Finished Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) is quarantined until the Quality Control department gives its final approval.
- Products are released for distribution only after meeting all specifications.
8. Documentation and Records:
- For traceability purposes, detailed records of all manufacturing steps, including raw material usage, production logs, and quality control results, are maintained.
- Batch production records are archived as per regulatory requirements.
Additional Considerations
- Den Mark Pharmaceuticals Pvt. Ltd. employs a well-trained staff who understand and adhere to GMP principles.
- The manufacturing environment is maintained clean and free from contamination.
- Regular equipment calibration and maintenance are performed to ensure consistent product quality.
- Stability testing is conducted to determine the shelf life of the product.
By following these strict procedures, Den Mark Pharmaceuticals Pvt. Ltd. a Bulk Drug Manufacturing Company, ensures the production of high-quality Clindamycin Phosphate + Nicotinamide Gel that meets all regulatory requirements and delivers therapeutic benefits to patients.