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Microbiology
-
Microbial Limits
-
Sterility testing
-
Spore counts
-
AMET
-
Antibiotic testing
-
Stability
Chemistry
-
HPLC
-
GC
- Wet chemistry
- Vitamin assays
- Degradation studies
- Stability
Validation Documentation
- Protocols(IQ,OQ,PQ, PV)
- Execution of data sheets (including
sampling and sample processing in our laboratory)
- Final reports
- Summary reports
Validation Services
- Process equipment Qualification
- Utility Systems Qualification
- Cleaning Validation
- Process Validation
- Test method validation
- Computer system validation
- PLC validation
- Facility (clean room) Validation
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Quality Assurance Systems
- Policies and Procedures
- Specification
-
Master batch records
- Employee Training
- cGMP Documentation
-
QC/QA Audits
Regulatory Liason
-
cGMP Compliance Evaluations
-
FDA 483 Responses
Design and Engineering
-
cGMP Design Reviews
-
Engineering Documentation System
-
Calibration Programs
-
Change Control Management
Strategic Planning
- Validation Master Plans
- Quality Assurance Master Plans
- Documentation Programs
-
Project Master Plans
-
Milestone development
Other Services
Environmental Monitoring
- Site mapping
- Establishment
of frequencies
- Microbial
(active air)
- Particulate
Raw material/Manufacturer analysis
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