Pharmaceutical contract manufacturer Den Mark Pharmaceuticals Pvt. Ltd. takes great pride in manufacturing pharmaceutical goods of the highest quality by rigorously following WHO Good Manufacturing Practices (GMP) criteria. This thorough manufacturing method outlines the procedures needed to produce 500 mg of azithromycin injection while maintaining safety, effectiveness, and regulatory compliance.
1. Starting Materials and Packaging
- Procure Azithromycin Dihydrate USP grade and all other excipients (inactive ingredients) from qualified vendors with relevant certificates of analysis (CoA).
- Ensure packaging materials like vials, stoppers, and labels comply with pharmacopeial specifications.
2. Pre-Production
- Production Planning: Prepare a detailed production plan outlining batch size, equipment allocation, workforce requirements, and timelines.
- Master Formula Record (MFR) and Batch Production Record (BPR): Reference the approved MFR for material quantities, specifications, and manufacturing instructions. Prepare a BPR for the specific batch, documenting all activities.
- Environmental Monitoring: Monitor ecological conditions (temperature, humidity, pressure) within designated zones to meet GMP specifications.
- Calibrations: Ensure all equipment used in the production process is calibrated and functioning within designated parameters.
3. Weighing and Dispensing
- Aseptic Techniques: Personnel must adhere to aseptic practices to minimize contamination.
- Weighing: Weigh Azithromycin Dihydrate and excipients using calibrated balances within a designated weighing area.
- Dispensing: Dispense the weighed materials into a suitable container following aseptic techniques.
4. Sterile Preparation
- Dissolution: Dissolve Azithromycin Dihydrate and other soluble excipients in a suitable sterile solvent (e.g., Water for Injection) within a designated area.
- Filtration: Pass the solution through a sterile filter with a pore size that retains microorganisms.
- Filling: Aseptically fill the pre-sterilized vials with the filtered solution using automated or semi-automated filling equipment.
5. Closing and Capping
- Use appropriate equipment to gently close the filled vials with sterile stoppers and secure them with caps.
6. Labeling
- Apply pre-printed labels onto the vials containing all mandatory information as per drug regulations (e.g., product name, strength, batch number, expiry date, manufacturer details).
7. Sterilization
- Autoclave or Lyophilization: To eliminate any microorganisms, subject the sealed vials to a validated sterilization process (e.g., autoclave or lyophilization).
8. In-process and Finished Product Quality Control
- Throughout the process, perform checks on:
- Weight: Verify that dispensed materials meet specifications.
- Appearance: Ensure solution clarity and absence of foreign particles.
- pH: Measure and document the pH of the solution.
- Sterility Testing: Conduct sterility testing on samples to ensure product sterility.
- Assay: Analyze 500mg of Azithromycin injection samples to confirm the declared amount.
9. Packaging and Quarantine
- Pack the finished Azithromycin Injection 500mg vials into cartons with a package insert containing product information.
- Quarantine the finished Azithromycin Injection 500mg batch until the Quality Assurance department reviews and approves all test results.
10. Release and Distribution
- The Azithromycin Injection 500mg batch will be released for distribution upon approval.
- Maintain proper storage conditions as per product specifications.
- Maintain complete batch records for future reference.
Additional Considerations
- Waste Management: Implement a system for safely disposing of waste generated during production.
- Deviation Handling: Document and investigate any deviations from the standard process.
- Audits: Regularly conduct internal and external audits to ensure ongoing GMP compliance.
By following this comprehensive and WHO GMP-compliant process, Den Mark Pharmaceuticals Pvt. Ltd. can ensure the consistent production of high-quality Azithromycin Injection 500mg.