Friability

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract anlytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Analytical Laboratory services includes ICP-OES (Inductively Coupled Plasma-optical emission spectroscopy), High Performance Liquid Chromatograph, Fourier Transform Infrared Spectrophotometry, UV/Visible Spectrophotometry, Gas Chromatography, Dissolution Profiling, Stability Testing as per ICH Guidelines, Quality Assurance by conducting Audits, Documentation, Regulatory Documentation Characterisation of API, Excipients and Drug Product, Impurity Profiling, Residual Solvents analysis in API and Drug Products, Microbiological Analysis, Contract Stability Services, Stability Indicating Method Development and Method Validation, Stability Protocol Preparation, Analysis & Monitoring, Assigning Shelf-life, Physical, Chemical, Microbiological, Instrumental analysis, Determination of Dissociation constants, Polymorph Studies based on differences in Solid Phase IR, Solubility Profile Evaluation at different pH, Material Compatibility Study, Analysis of Starting Materials, Preservative Efficacy Test, Dissolution Profile, UV Assay, FT-IR, Stability Testing, Stability Indicating method development, validation, & testing, Cleaning Validation, Photostability, Microbial methods, Disintegration, Elemental Analysis, Residue on Ignition (ROI), Loss on Drying (LOD), Material Identification, Moisture, Hardness, Osmolalility, Method Validation, Excipient Identification and Quantitation, Forced Degradation, Chromatographic Purity, Related Substances and Impurities, Dose uniformity, OVIs, Determination of actives/excipients, Investigative Study, Comparability Study, Cleaning Validation, Dissolution USP 1, 2, and 4 etc. Quality Compliance testing is done a wide variety of raw material and finished product forms including Active Pharmeceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc. CHEMICAL AND PHYSICO-CHEMICAL TESTING also involves Assays (e.g. UV/Vis, IR, AAS, etc.), Chromatographic tests (e.g. HPLC, GC, IC, ICP-MS), Identification of active ingredients and Impurities, Physical and physico-chemical determinations (e.g. pH, viscosity,bmelting point, particle size, osmolality band osmolarity, flash point, loss onbdrying) Limit tests (e.g. heavy metals, ash, anions), Residual solvents (volatile organic compounds [VOC], organic volatile impurities [OVI]), Solid oral dosage QC tests (e.g. disintegration, dissolution, hardness, friability), Sampling and analyses of water for pharmaceutical purpose and controlled process environments (e.g. TOC, conductivity). Many testing capabilities of CRO’s also involve Particle Size by Sieve Analysis, Friability, Moisture determination, Viscosity, Total Organic Carbon (TOC), Trace Metal analysis, Water Content, Specific Rotation, Melting Point, Particle Size determination, Microscopic analysis, Titration, Mercury determination, Pharmaceutical X-Ray, Diffraction (XRD), H1 and C13NMR, Nutritional supplements analysis. The FDA Guidance (July 2015) on Analytical Procedures and Methods Validation for Drugs and Biologics serves as a complement to ICH Q2(R1).6 Other useful guidance documents include ICH Q3A – Q3D Impurities and ICH Q6A – Q6B Specifications.7 The FDA not only expects drug developers to follow the guidelines, but also to provide greater analytical details on drugs and process development as demonstrated in CMC data.4 Experienced analytical service providers with a track record of regulatory compliance can be of great aid to help drug developers prepare CMC documents with sufficient data for regulatory submissions.