Aseptic Operations 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.
Example Projects
Aseptic Manufacturing Site GAP Assessment - Pharmaceuticals
MEDVACON Life Sciences was engaged by a pharmaceutical client to conduct a GAP analysis of their manufacturing operational facilities and quality systems for the manufacturing of their Aseptic product against the current requirements and expectations, as well as draft Annex 1 guidance for manufacturing Aseptic Drug Products distributed in the EU and UK. In addition, GAP analysis of the entire manufacturing process from receipt of raw materials through batch testing and release by QP in EU member state was performed. MEDVACON also remediated the Quality System in anticipation of an FDA Pre-Approval Inspection.
Parenteral Drug Product - Aseptic Operations
MEDVACON is currently supporting a client’s new parenteral drug development project at a CMO site. MEDVACON ‘s involvement includes a quality assessment of the Aseptic facility, review of manufacturing procedures, review of Aseptic gowning procedures and personal training, review of environmental monitoring procedures and data, review of media fill batch record, interventions and execution, and review of process validation for the new drug product.
End-to-End Assessment Nucleotides, Nucleoside Triphosphates, and Oligos Manufacturer
MEDVACON Life Sciences was engaged by an Aseptic Nucleotides, Nucleoside Triphosphates, and Oligos Manufacturer to conduct an end-to-end assessment of the facility. In addition, MEDVACON was engaged to provide on the job coaching and classroom training of the technicians to ensure proper Aseptic operation.
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