API and Finished Pharmaceutical Manufacturing
GMP Audit of Facilities & Operations
HPLC Analysis
Environmental Control Monitoring Systems
Aseptic Dry Powder Filling Operations
Sterility Testing
Lab Equipment Qualification
Sterile Processing Equipment Qualification
Manufacturing Equipment Qualification
Process Validation
GMP Training Program Development
QMS Gap Analysis
Process Documentation
Cleaning Qualification
Performance Monitoring Reports
Write policy and procedures
Insure Compliance with Applicable Local and IRB / IEC Requirements
Protocol and SOP Writing and Tracking
Provide training for Investigation & documentation of OOS Events
Document Collection, Review and Maintenance
Identify, Monitor, Document and Track Out-Of- Scope Activities
System Life Cycle Validation Documentation of Computer & Automation Systems
Investigate & Identify Anomalies & Abnormalities – testing including GC, LC, UV AND IR spectrophotometer tests
Host Workshops on Investigation Techniques & Documentation for Manufacturing Atypicals
Write Effective Investigations, Corrective Actions and Preventative Actions to close out Existing Deviations
Please contact us at (540) 432-1514
57 South Main Street Suite 606 Harrisonburg, VA 22801 Fax: (540) 801-8397
Charlie Hildebrand: President / CEO Sean Ryman: VP Operations / CFO