Specifications or standards, usually proposed by pharmaceutical manufacturer, official compendiums and regulations promulgated by FDA, are aimed to provide desired characteristics and acceptable tolerances for regarding the four attendant procedures, involving raw materials, manufacturing procedures, finished product testing, and control of identity. On this basis, the criteria provide an objective determination of whether pharmaceuticals are properly constituted. Conformance to these standards assures pharmaceuticals to be eligible and circulating within market.
With regard to the grounds above, two components here are noted to be vital to contribute to such standards: 1) appropriate analytical procedures to permit a comprehensive examination;
In order to meet the standard of identity, strength, quality, and purity and make the end products safe and efficacious with uniform potency and purity, and acceptable color, flavor, and physical appearance, it is important to put time to the process and run rigorous quality control.
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· A wide range of analytical technologies including: HPLC (UV, PDA, FLU, ELSD, RI), UPLC (TUV, PDA, SQD), H-Class HPLC method development, LC/MS/MS, Maldi-Tof, GC, Isolator Technology, APSD (NGI, ACI), ELISA, SDS-PAGE.
· Complete microbiological testing including: Sterility Testing, Bacterial Endotoxin (LAL) Testing, Bioburden analysis – Harmonised Absence of and Total Viable Counts, Microbial Identification, Preservative Efficacy Testing, Microbiological antibiotic assay, Specialist Microbiological Method Development and Validation.
· Complete compendial analysis (BP, EP, JP and USP).
· API, IMP, FP Batch Release Testing and Lot Release Testing for small molecules, inhaled products and biopharmaceuticals.
· Method transfer and analyst exchange.
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