CEGIA erepseronsom | RUGS & PHARMACEUTICALS . . . a a a a CEG Test House And Research Centre Pvt. Ltd. B-11(G), Malviya Industrial Area Jaipur - 302017 INDIA Tel:+91-141-4046596 www.cegtesthouse.combees DRUGS & PHARMACEUTICALS AND RESEARCH CENTRE PVT.LTD. 2 Any pharmaceutical product manufacturer, requires a quality control which is one of the foremost requisite with regard to regulatory compliances. A significant portion of the CGMP regulations (21 CFR PART 211) and all pharmacopeia methods such as USP, IP, EP, JP, BP and In-house methods pertain to the quality control testing of products. CEGTH provides expert analytical services in all areas of testing from raw materials, excipients, APIs, Bulk drugs, intermediates to finished products. Data Integi is being handled in compliant with CFR 211 regulations subsections (a) to (g). All the data acquisition systems are linked through software ensuring data security from generation till archival of electronic data. Our services include: PHARMACOPEIAL TESTING: Raw materials, Excipients, APIs, Bulk Drugs, Finished products & others ANALYTICAL R&D: + Analytical method development and validation as per ICH guidelines + Impurity identification and quantification + Heavy metal estimation by ICP OES/MS + Cleaning validations, Dissolution studies * Extractable and Leachable studies (CHEMICAL: * Residual Solvents & pesticides + Heavy Metal analysis by ICP- MS/MS + Myco- & Ochra-toxins -chemical properties + Physi MICROBIOLOGY: + Limit tests as per Harmonised protocol + Sterility Testing + Test for specific micro-organisms + Bacterial Endotoxins Test as per LAL/Gel clot method + Allergens like Gluten, B lactoglobulin, DON etc. by ELISA * Preservatives Efficacy / Antimicrobial Effectiveness Testing * MLT, BET, Bioburden, Sterility method Validations icrobial assays * Chemical disinfectant testing and cleaning studies * Minimum Inhibitory Concentration (MIC) CEG Test House And Research Centre Pvt. Ltd. B-11(G), Malviya Industrial Area Jaipur - 302017 INDIA Tel:+91-141-4046596 www.cegtesthouse.com