In today's pharmaceutical industry there is a definite need to understand technical and quality issues regarding daily operations, science and regulatory requirements.
PMcG Consulting offers Technical and Quality support to:
- Laboratories
- Manufacturing sites
- Distributors
- Companies who require additional technical understanding during regulatory audits
To assist with technical problem-solving relating to:
- Analytical Procedures (QbD Lifecycle approach, Development, validation, Verification and Transfer)
- OOS Investigations
- Stability studies
- Cleaning validation.
- Facility Validation
- Manufacturing Process Validation
- Analytical Method development and validation
To assist with opportunities for improvement within the Quality Management System:
- Root cause investigations
- Corrective and Preventative Actions
- Trending of Quality System Incidents for continual improvement
- Self-Inspection program
- Training Programs
- Master validation plans
- Data Integrity considerations
- Quality Management Systems
- Quality System Elements
- Compliance with Good Manufacturing Regulations
Technical support is also offered to help prepare for and participate in Regulatory audits.
If you would like to discuss how we can provide technical support or require further information, please: Contact Us