Stiriti

The laboratory facilities at Stiriti constitute a hub for wide variety of activities – development, validation, monitoring and supporting the formulation and manufacturing process.

The lab has the most advanced equipment: UPLC, UPLC-MS, ICP, ICP-MS, DSC, TGA and LC-MS. This equipment helps our lab personnel to characterize active pharmacological ingredients (API) and finished products that help in formulating stable and scalable dosage forms.

By establishing coordinated work with the Agricultural Universities every effort is made to source authentic herbs only. Headed by Quality Program Director, the laboratory has completed more than 12 research projects. All processes at the lab are documents and guided by the Non-disclosure Agreement (NDA) signed with our clients. The laboratory is also equipped with

Reactors and extractors to process four 25gms of raw herbs to 5kg of herb.

Dryers for lab scale drying systems for vacuumized drying or controlled spray drying.

The Analytical Lab at Stiriti monitors all incoming raw materials, with focus on heavy metals. The lab analysts are trained by the equipment manufactures to ensure quality work and precision results. The equipment used in the lab is 21 CFR compliant. The final product that goes out of the manufacturing facility is in accordance with Prop 65 regulation. We take third party expertise when deciding on the microbiology per current USP/NF.

The QA and Regulatory functions are performed by a panel of experts. Each expert brings experience in Life Sciences, Biotechnology and Pharmaceutics.

Identity confirmation is achieved by

Assay Development is assured by,

Mineral and heavy metal detection in raw materials
is monitored by

Thin layer chromatography	High performance Liquid Chromatography (HPLC)	Heavy metals by AAS-GF and HVG
Botonical macroscopy and microscopy	Gas Chromatography	Flame photometry
Fourier transform Infra Red Spectroscopy	UV spectroscopy (UV)	Gas chromatography

We ensure that all products and their ingredients are tested for their purity, strength, composition, identity and quality. Our facilities are registered with FDA and are cGMP compliant. Quality control at Stiriti includes adherence to Standard Operating Procedures (SOPs) that comply with the FDA’s Good Manufacturing Practices (GMPs). Quality control takes place at 3 levels.

	Supplier Qualification: Ingredients and raw materials’ facilities are routinely audited by our QA personnel
	In-process QC: Quality checks are done at every stage of the manufacturing process. Each batch of the product is subjected to disintegration, weight variation, thickness, friability and metal detection tests
	Finished products QC: Tests are conducted to know each products purity, strength, composition and physical criteria

We have made a clear demarcation between Quality Assurance (QA) and Quality Control. The former relates to all the process based quality initiatives: GMP Certification, batch records, document control and regulatory. Quality control is related to all lab-based functions: Microbiological testing, assays, identity testing and other facets of technical support.

Stiriti is a 100% Export Oriented Unit (EOU) with total commitment to quality excellence. We adhere to the latest GMP standards, and the client’s compliance norms.