Any pharmaceutical product manufacturer, requires a quality control which is one of the Pre- requisite to regulatory compliances. A significant portion of the cGMP regulations and all pharmacopeia methods such as USP, IP, EP, JP, BP and In-house methods pertain to the quality control testing of products. Shiva provides expert analytical services in all areas of testing from raw materials, excipients, APIs, Bulk drugs, intermediates to finished products. Shiva's sophisticated pharmaceutical testing lab operates as an extension of your QC and Analytical R&D laboratories.

Data Integrity is being handled in compliant with (21 CFR Part 11) regulations subsections (a) to (g). All the data acquisition systems are linked through ECM software ensuring data security from generation till archival of electronic data.

Our services include

Pharmacopeial Testing:

• Raw materials
• Excipients
• Active pharmaceutical ingredients(APIs)
• Bulk Drugs
• Finished products
• Herbal product analysis
• Medical Devices

Analytical R&D:

• Analytical method development and validation as per ICH guidelines
• Development of Stability-indicating methods
• Impurity identification and quantification
• Method Development and Validation for Heavy metal estimation by ICP-OES and ICP-MS
• Cleaning validations
• Dissolution studies
• Extractable and Leachable studies
• Stability studies as per ICH guidelines

Apart from Pharmacopeial testing of finished products, some of the analysis carried out as per validated methods on raw materials are:

Chemical:

• Residual Solvents
• Residual Ethylene Oxide, Ethylene Glycol & Ethylene Chlorohydrin
• Heavy Metal analysis by ICP-OES and ICP-MS
• Residual Pesticides
• Ochratoxins
• Aflatoxins B1:B2:G1:G2 & M1
• Physico-chemical properties
• BET surface area

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, Beta lactoglobulin, DON etc.by ELISA
• Mycotoxins by ELISA
• Preservatives Efficacy / Antimicrobial Effectiveness Testing
• Bioburden Testing
• MLT, BET, Bioburden, Sterility method Validations
• Microbial assays
• Environment monitoring for clean rooms
• Sampling and analysis of water for pharmaceutical microbiology
• Chemical disinfectant testing and cleaning studies
• Microbial identification
• Minimum Inhibitory Concentration (MIC)

For further information about how partnering with Shiva can benefit your organization, please feel free to contact us. Discover why Shiva is also the preferred partner for Minerals & Ores, Materials, Food & Beverages, Industrial Hygiene and Fuels & Oils testing.

Pharma Lab Capability Presentation

Extractable and Leachable Studies