| Pharmaceuticals Testing Laboratory |
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Basic Purpose of Laboratory:
Analysis of prescription and 'over-the counter' pharmaceutical samples and raw and drug precursor materials to determine identity, purity, packaging accuracy, dosage, source, extraneous material, constituents and hazardous materials present.
Range and Types of Samples:
All types of samples obtained from manufacturers, government customs and regulatory inspection agencies.
Scope of Work and Supply:
Identification of the analytical procedures to be used; determination of the instruments, equipment, and laboratory information management systems specifications, and consumables, supplies, spare parts required for the operation of a fully functioning Pharmaceutical Testing Laboratory. Thermo's scope can include project management, procurement, delivery, installation, and commissioning, training, warranty and product support, and preventive maintenance agreements to provide a fully functioning laboratory on a "turnkey" basis.
Identification of Analytical Methods to be used and determination of recognized legal authorities:
Based on analytical procedures recognized by the US FDA and listed in the U.S. Pharmacopoeia and National Formulary. Other reference methodologies can be used if required by geopolitical considerations.
Sampling Techniques, Frequencies and Handling:
Covers the identification, implementation of government and industry recognized techniques for the safe and proper taking of samples for analysis, estimation of required sampling frequency for target confidence levels and the proper temporary/long-term storage conditions of samples.
Recommended Instrument / Equipment Lists:
Develop and specify instruments, equipment lists based on the selected analytical testing methods for the types of pharmaceutical samples to be analyzed, includes: standard instruments for physical, microbiological and chemical testing, standard lab equipment, lab information management systems, supplies and consumables.
Laboratory Layout:
Layout and design of laboratory furniture and equipment placement that takes into consideration the space available (or defining the space), sample flow, utility requirements and distribution, special requirements for hazardous sample handling, storage, sterilization, sample retention, and office/clerical/supervisory office space. Mobile, or field self-contained testing units are also considered and planned.
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