QualPharm offers a wide range of consulting services and expertise that support all facets of pharmaceutical manufacturing. As a consortium, we have worked together on multiple projects and therefore we can provide you with a true team of experts. Whether your firm is under regulatory action requiring remediation or you are seeking means of continuous improvement, QualPharm has the expertise to work side-by-side with your staff to take your company to the next level.

Quality System Development/Implementation

Quality Management
Quality Metrics Development
Deviation Investigation and Reporting
CAPA Management and Effectiveness
Change Control
Product Disposition
Internal Assessment/Audit Systems
Supplier/Vendor Quality Program

Remediation

Agency Response Assistance
Focused and Integrated Quality System Assessment
Comprehensive Remediation Planning with Focus on Sustainability
Management and Staff Mentoring
Development of Metrics to Track Improvement
Follow Up to Ensure Sustainability

Manufacturing Support/Validation

Process Qualification/Validation
Continued Process Verification/Process Control and Monitoring
Aseptic Manufacturing and Sterility Assurance
Cleaning Validation
Technology Transfer and Commercialization

Quality Control

Analytical Method Validation and Transfer Processes
Data Collection, Review, Reporting and Integrity Assurance
OOS, OOT and OOE Investigation and Review
Instrument Qualification
Stability Program

Auditing

GMP Internal Audits and Audit System
Raw Material Supplier Audits
Third Party and Contract Manufacturer/Contract Laboratory Audits
Process Development and Technology Transfer

Policies and Procedures

Evaluation/Recommendation for Hierarchy of Policies and Procedures
Document Preparation
Document Review and Implementation

Training

Inspection Planning and Readiness
CGMP – General and Specific Topics