ASEPTIC Operation Evaluation & Remediation

MEDVACON will perform a targeted assessment or an overall end-to-end assessment of the aseptic manufacturing operation identified in the bullets below. For end-to-end assessments, Medvacon Senior Consultants will observe manufacturing operations on all shifts over a multi-week period. During this initial observation period, the consultants will observe and learn how the technicians perform and execute the processing steps during the observation and learning period, the consultants will provide monitoring and mentoring of the technicians. After the multi-week period, the MEDVACON consultants will provide an overall assessment of the operation to senior management along with recommendations for improvement. These recommendations will cover the FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing.

Current Good Manufacturing Practice:

• Building and Facilities
• Environmental Monitoring & Personal Training
• Qualification & Monitoring
• Endotoxin Control
• Time Limitations
• Validation of Aseptic Processing and Sterilization
• Media Fills
• Laboratory Controls
• Sterility Practice

Following discussions with senior management, MEDVACON will provide new or enhanced training or refresher training for the technicians if needed. Some of this training may be in conjunction with regularly scheduled staff training to reinforce Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Once training is complete, the MEDVACON Consultants will reassess the operators' manufacturing execution progress. Additional shift observations will be conducted post-training as part of the re-evaluation. Further recommendations to senior management will be provided. Medvacon will provide a report of post-training observations and assessment of the mentoring and training effectiveness.