Drug Products
Qualiance can assist you, including:
- Quality & Regulatory strategic planning and assessment
- Quality System
- Prepare and maintain effective Quality System (Standard Operating Procedures, SOPs) that complies with Good Manufacturing Practices (GMP), and simple and flexible enough to support operational excellence
- Quality Assurance, Quality Control and Regulatory Affairs including leadership support (short term and long term)
- Set up of Quality Assurance/Quality Control department and provide support to clear any backlogs related to quality system and compliance requirements
- Prepare and maintain (as applicable) in process, bulk and finished product specifications to meet the Health Canada requirements
- Prepare and maintain the specifications and release criteria of materials including but not limited to raw materials, ingredients and packaging materials etc
- Change Controls, Risk Assessment & Management
- Deviation, OOS investigations, Incident investigations & CAPA’s
- Product releases as a Quality Control/ Quality Assurance
- Review of product labels, batch records, certificates of analysis, finished product release specifications, sanitation records including other applicable records and final product releases
- Review of analytical methods validations, verifications, and suitability studies as applicable
- Review and support timely closure of batch related deviations, OOS investigations, change controls and CAPAs
- Audits/Inspections
- Quality and Compliance support /Inspections and compliance verifications (remote and onsite) including both pre-Health Canada, post- Health Canada and client or foreign regulatory agency audits
- Host Health Canada, third party, internal audits, or self-inspection program from start to close-out
- Third party audit services for GMP (Good Manufacturing Practices)
- GMP GAP Analysis, recommendation plan & readiness
- Training, Education & Hiring
- Onsite - Virtual training and education including annual GMP and customized trainings
- Employees training effectiveness assessment and verification
- Hiring and training of quality and compliance departments key personnel
- Training for compliance remediation
- Validations/Qualifications
- Validations, Verifications & Qualifications of equipment, process and supporting systems
- Effectiveness of cleaning and cleaning validation
- Temperature Mapping and Transportation Validation/Qualifications Studies
- Environment Monitoring Studies
- Review of validations/qualifications protocols/ reports and their assessment
- Supplier/Vendor and Materials management
- Quality management and audits of vendors
- Periodic evaluation and assessment of vendors
- Materials assessment and recommendation
- Pharmacovigilance & Post-market surveillance
- Ensure Good vigilance practices
- Prepare Annual summary report preparation
- Complaints handling, assessment, investigation and recommendation for applicable preventive and corrective actions
- Complaints trending
- Adverse reaction assessment and reporting
- Technical Services
- Materials assessments, product development, R&D, and formulations review
- NDA, Quality Agreement, Supply Agreement, Pharmacovigilance, and other technical agreements
- Quality System Documentation/Quality & Continuous Improvements
- Quality Assurance and Regulatory Affairs due diligence, strategic, technical consulting, and Project Management
- Mock recall, recall assessment & management
- Stability studies management, trending, review & assessment
- Annual Product Quality Review
- Risk assessment and management
- Business and process analysis
- Licence maintenance & management
- Licence Amendments and Notifications