PDA offers comprehensive consulting services:
CAPA- corrective and preventative action
Root cause analysis
Our team can identify main issues on failure and prevention in regards to contamination. Issues may range from raw material not meeting Certificate of Analysis to water systems, production line, environmental issues, human contamination, and a variety of internal process breakdowns.
API and aseptic fill-finish production monitoring and microbial control
cGMP compliance / cGMP Annual Training
Cleaning validation / Method Validation
Disinfection, sterilization and the use of biological indicators
Facility design and qualification
Sterility assurance and aseptic processing
Testing Services - Microbiology / Chemistry
Microbiology / Chemistry development (method and protocol)
Investigations of laboratory and production of microbial excursions and OOS Results and aberrant data
Years Of Experience
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PDA Laboratories, Inc.
6 North Corporate Drive
Riverdale, NJ, 07457