→ Sustainability:
Environmental responsibility is a fundamental principle guiding our operations. Our R&D facilities prioritize sustainable manufacturing processes, adhering to eco-friendly practices that contribute to a greener and more sustainable pharmaceutical industry.
→ Global Regulatory Compliance:
With a deep understanding of international regulatory frameworks, our R&D facilities ensure that our APIs meet the diverse regulatory standards of markets worldwide, providing confidence to our partners and customers.
→ Collaborative Partnerships:
We actively foster collaborations with renowned academic institutions, research organizations, and industry experts. These partnerships create a culture of open innovation, enabling us to leverage collective expertise and stay at the forefront of pharmaceutical advancements.
Through unwavering commitment to innovation, quality, sustainability, and global compliance, we are shaping a healthier future for patients worldwide, one API at a time.”
“At our advanced analytical laboratory, we have an experienced and qualified team of scientists who are deeply committed to their work. Their expertise encompasses a wide range of critical functions.”
1. Analytical Method Development, Calibration, and Validation:
Our scientists are adept at developing, calibrating, and validating analytical methods to ensure the precision and reliability of our results.
2. Structural Identification and Elucidation:
They excel in identifying and elucidating the structures of various compounds, a crucial aspect of drug development.
3. Impurity, Byproduct, and Metabolite Isolation:
Within our laboratory, we have the capability to isolate and characterize impurities, byproducts, and metabolites, which is essential for maintaining the purity of pharmaceutical products.
4. Analytical Technology Transfer and Documentation:
We facilitate seamless technology transfer and maintain meticulous documentation practices to meet stringent regulatory standards.
5. Stability Studies as per ICH Guidelines:
Our laboratory conducts stability studies following the guidelines established by the International Council for Harmonisation (ICH), ensuring the consistent quality of our products over time.
Our Analytical Development laboratory is equipped with state-of-the-art specialized equipment including High- Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Liquid Chromatography-Mass Spectrometry (LCMS), Gas Chromatography-Mass Spectrometry (GCMS), Flash-Chromatography, Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Particle Size Analyzers, Nuclear Magnetic Resonance (NMR) spectrometers, and various other essential tools such as colourimetry, auto-titrators, and stability chambers.
This comprehensive infrastructure empowers our team to deliver precise and high-quality analytical services, playing a pivotal role in pharmaceutical development and ensuring the highest standards of product quality and safety.”
Process Safety Studies
We prioritize the creation of inherently secure procedures. To facilitate this, our state-of-the-art Process Safety Laboratory, complementing our Process Chemistry lab, plays a pivotal role. This specialized facility is equipped with cutting-edge capabilities and infrastructure, including:
1. Health And Environment Hazards:
- Health and environmental hazards are identified through the in-house SDS generated through GHS-compliant software.
2. Chemical Reaction Hazards data generation and its interpretation :
A dedicated team equipped with advanced laboratory equipment conducts different process safety studies.
3. Fire and Explosion Hazards:
- We carry out thermal stability tests and other fire and explosion tests, especially for powder safety testing.
4. Material Safety Management and Product Stewardship:
- At Shree Harikrushna International, our commitment to safety extends to our comprehensive Safety Data Sheet (SDS) database, encompassing all GHS-compliant products and chemicals in use. In line with our ‘Responsible Care’ ethos, we’ve developed in-house capabilities to efficiently retrieve and generate new Material Safety Data Sheets (MSDS) for our developmental products. This capability not only reinforces our dedication to responsible material safety management but also plays a pivotal role in establishing robust product stewardship practices for both existing and new products. It empowers our employees and customers with the necessary information and guidelines to ensure safe and responsible handling of our chemicals and products, underlining our commitment to their well-being and safety.”
Waste Pre-treatment Studies :
Our waste pre-treatment studies aim to reduce the environmental load at the process design stage while targeting various environmentally important parameters such as:
1. COD
2. BOD
3. TSS
4. TDS
5. pH
6. Ammoniacal Nitrogen content
1. Bromide content
2. Chloride content
3. Sulphate content
4. Metal content
Standard Operating Procedures :
This SOP applies to all personnel involved in the manufacture of pharma APIs. Responsibilities:
→ The Quality Assurance (QA) Manager is responsible for approving and maintaining this SOP.
→ The Production Manager is responsible for ensuring that all personnel involved in the manufacture of pharma APIs are trained on this SOP and that manufacturing operations are conducted in accordance with this SOP.
→ All personnel involved in the manufacture of pharma APIs are responsible for following this SOP.
Procedure
Records:
- All records related to the manufacture of pharma APIs must be maintained and retained for a specified period of time in accordance with all applicable regulations.
Approvals:
- This SOP must be approved by the QA Manager and the Production Manager.
Revisions:
- This SOP will be reviewed and revised on an annual basis or as needed.