PHARMACEUTICAL GRADE LABS & CLEAN ROOMS

AUDIT PREPARATIONS

• We will guide the lab through the process, performing a thorough mock inspection and give valuable feedback to   ensure the lab is fully prepared.

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• We are proficient in:

  • ISO  14644-2 Cleanrooms and associated controlled environments

  • ISO 13485 – Medical devices Quality management systems Requirements for regulatory purposes

  • ISO-9001:2015 - Quality Management Systems

INSTRUMENT/EQUIPMENT & ENVIRONMENTAL VALIDATION

• Assist the lab with creating a validation plan for new instrumentation and equipment.  We offer comprehensive assay validation support to ensure the new instruments meets the necessary requirements and standards.

ENVIRONMENTAL MONITORING

• Monitoring:  Air, Surface, Water, Climatic conditions study

• Assist with:  Room classifications as it relates to ISO requirements

  • Room validation

  • Implementation of Monthly Monitoring Plan

  • Temperature Mapping validation