Project Description
FDA cGMP microbiology laboratory needed for microbiological and sterility testing of generic drug products (tablets, capsules, and injections) including EP European Pharmacopoeia microorganisms parameter assays, microbial enumeration tests, total aerobic microbial count (TAMC) CFU/g or GFU/ml, total combined yeasts/molds count (TYMC) CFU/g or GFU/ml, microbiological identification, Escherichia coli, Salmonella, Pseudomonas aeruginosa, and Staphylococcus aureus.
Project Information
Number:17-00911
Other pharmaceuticals and biopharmaceuticals laboratory services.
Other Pharmaceuticals and Biopharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :
- Drug Discovery Testing
- Drug Development Testing
- Non-Clinical Study Testing
- Preclinical Study Testing
- Clinical Trials Testing
- Pharmacokinetics (PK) Testing
- Pharmacodynamics (PD) Testing
- ADME Testing
- Sterility Testing
- Pyrogens Testing
- Endotoxins Testing
- Raw Material Testing
- Finished Product Quality Control Release Testing
- Real-Time Stability Testing
- Accelerated Stability Testing
- Method Development Testing
- Method Validation Testing
- Drug Release/Dissolution Testing
- Extractable Testing
- Leachable Testing
- Elemental Impurities Testing
- Packaging Testing
- Child-Resistant Packaging Testing
- Container Closure Integrity Testing (CCIT) Testing
- High Throughput Screening Testing
- Reverse Pharmacology Testing
- Excipients Testing
- Active Pharmaceutical Ingredient API Testing
- Toxicology Testing
- Toxicity Testing
- Microbiology Testing
- Strength Testing
- Quality Testing
- Purity Testing
- Consistency Testing
- Acid Insolubles Testing
- Acid Solubles Testing
- Alkali Solubles Testing
- Alkalinity Testing
- Appearance Testing
- Boiling Point Testing
- Congealing Temperature Testing
- Flash Point Testing
- Melting Point Testing
- Freezing Point Testing
- Hardness Testing
- Heat of Combustion Testing
- Preservatives Testing
- Loss on Drying (under Vacuum) Testing
- Loss on Ignition Testing
- Melting Point Testing
- Mineral Analysis Testing
- Non-aqueous Titration Testing
- Normality Testing
- Organic Acids Testing
- Organic Extractives Testing
- Oxidizing Substances Testing
- Peroxide Value Testing
- Pour Point Testing
- Reactivity Testing
- Reactivity to Water Testing
- Reducing Substances Testing
- Refractive Index Testing
- Residue on Evaporation Testing
- Residue on Ignition Testing
- Saponification Value Testing
- Sieve Analysis Testing
- Silver Reducing Substances Testing
- Silicon Testing
- Sulfur Testing
- Sodium Testing
- Specific Gravity Testing
- Specific Rotation Testing
- Sugars Testing
- Sulfur Compounds Testing
- Surfactants Testing
- Talc Testing
- Titration Curve Testing
- Total Halides Testing
- Total Reducing Compounds Testing
- Unburned Carbon Testing
- Uncarbonized Constituents Testing
- Unsaponifiable Matter Testing
- UV Absorption Testing
- Volatile Matter Testing
- Volatile Suspended Solids Testing
- Weight Variation Testing
- Cytotoxicity Testing
- Elution Testing
- Agar Diffusion Testing
- Bioburden Testing
- Antimicrobial Effectiveness Testing
- Particulates Testing
- Total Combined Mold & Yeast (TYMC) Testing
- Total Aerobic Microbial Count (TAMC) Testing
- Testing
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