Pharma and Biotech Support
Introduction
In the ever changing world of drug manufacturing it is critical that the quality of the products supplied or purchased must be an absolute. GovMojo’s principle has over 25 years of worldwide validation and auditing experience within the pharmaceutical and biotechnology industries. We can provide you engineers and project managers to support validations and audits for small and large scale facility qualifications.
Services
- Full Spectrum Validation Support (IQ / OQ / PQ / Process Validation)
- Project Management
- CAPA Investigations
- 483 Observation Remediation
- Consent Decree Remediation
- Internal and External Audits
- Equipment Specification Development
- Factory Acceptance Testing
- Training Programs for Staff
Experienced In
- Small and large molecule formulation
- Sterile and non-sterile product presentations
- Tablet and capsule production
- Lyophilization
- Packaging
- Media Fills
- Shipping and Storage
- ETO Finished Product Processing
- Terminal Sterilization
- Facilities and Utilities
Autoclaves
Recognized as a leading expert on autoclave usage and the instructor of the PDA’s course on Technical Report No. 1 (2007) Revision, Validation of Moist Heat Sterilization Process: Cycle Design, Development, Qualification and Ongoing Control
Certifications
