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

COMPLIANCE

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

OUR PARTNERS

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.

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