Azithromycin Injection

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.