GMP & CLEANROOM SERVICES
Assistance in meeting regulations of the WHO, FDA and other organizations
Proper understanding of site specific Good Manufacturing Practices
Proper understanding of site specific Standard Operating Procedures
Knowledge and understanding of chemical requirements and use
Knowledge and understanding of equipment requirements and use
Compliance with access control and proper entry - exiting flow of areas
Compliance with logbook and other document control
Continuous training on any procedure or policy changes
Class 1 to Class 10,000 control
Compliance with site specific gowning and uniform procedures
We understand the importance of every single item produced meeting compliance. Even the smallest mistake can result in contamination and a loss in product quality. An emphasis is placed on the complete following of all Good Manufacturing Practices to meet WHO and FDA guidelines.
We aim to continually support all improvements and changes to your operating procedures and work as a team to ensure 100% compliance throughout the process.
At startup, critical care is taken during the transition period. Management works along side crew supervisors and your team to create a bullet proof plan ensuring the transition does not result in any deviations.
Train crew on sites GMP and SOP standards
Review of site specific GMP requirements
Initiate Quality Control program to verify compliance
Retrain crew on changes to ensure continual compliance
Develop strategy to ensure a deviation free transition
Management works with crew to verify 100% compliance through transition period
Work with site contacts to support any SOP changes
GET YOUR FREE QUOTE
Schedule a walk through, after reviewing your facilities requirements we'll create a scope of work and provide you with a written proposal good for 90 days.