Global regulatory and quality standards (such as ICH Q7, 21 CFR Part 210, 211, EU GMPs, and GMP guidelines from TGA, PMDA, TPD, WHO) have been used while designing the quality systems and compliance standards at Sai as evidenced by more than 300 successful client/third party audits (full cGMP audits, regulatory audits; USFDA, Mexican authorities, QP audits, etc). The quality standards are harmonized across all Sai’s units and governed by Corporate QA policies.
The quality systems are continuously monitored and reviewed, with the involvement of Senior Management, to identify areas for improvement.
Key quality factors at Sai include:
- Adherence to Quality Agreements
- Stringent and systematic controls on data generation, review and product release.
- Scientific approach in investigation of deviations/our of spec (OOS) and customer complaints leading to a conclusive CAPA (Corrective and Preventive Actions)
- Document control
- Vendor management
- Change Management
- CAPA management
- Annual Product Quality Reviews for established products
- Management Reviews
- Quality Risk Management
- Validation Master Plan (e.g. Facilities, equipment, manufacturing process, cleaning processes, etc.)
- Equipment qualification, calibrations
- Analytical methods development and Validation
A well-structured team of professionals, with significant experience within the pharmaceutical sector, coordinates regulatory affairs at Sai. This team is located at the corporate office and supported by on-site QA/RA heads. The RA department takes care of managing regulatory submissions and amendments; communications with Regulatory Agencies (USFDA, EU MS etc.) as well as continual training in the regulatory requirements. With a strong track record of dealing with variations, additional requests, enquiries, onsite pre-approval inspections and renewal inspections by respective agencies, the team is also able to smoothly handle NDAs, INDs, DMFs, ANDAs, MAAs and other regulatory submissions.
Health, Safety and Environment (HSE)
Sai views HSE as an integral part of our business and one which continually impacts our decision making process. Our mission is to stand among the best within the pharmaceutical sector in terms of HSE and we are led by our guiding principles: “All incidents are preventable” and “Good HSE means Good Business”.
Sai’s policy on HSE and sustainability clearly communicates the organization’s aspirations in these key areas and provides guidance and direction to help our associates in spearheading best in class standards.
We show utmost care for our associates and continually endeavour to provide a safe and healthy workplace. It is understood that attaining safety excellence requires the consistent focus and attention of every associate. We nurture employee awareness through periodical training programs based on internal training assessment exercises and implemented as part of an annual training plan.
We have established procedures for Risk Assessment and Hazard Operability Studies and put in place an HSE assessment mechanism.
We foster the concept of inherent safety and ensure that the facilities are ‘safe’ by design. Action follows a hierarchal series of Occupational Health and Safety controls from Elimination through Substitution, Engineering and Administrative controls with Personal Protective Equipment only necessary as a last resort.
Our capabilities within Occupational Safety & Health include:
- In-house thermal process safety laboratory, wherein we evaluate thermal process safety using Reaction Calorimeter and Thermal Screening Unit
- Facilities are equipped with fire detection and notification systems
- Facilities are equipped with firefighting systems
- Emergency planning implemented and practiced in regular drills.
- Fully equipped Occupational Health Centers
- Industrial hygiene and Occupational health – Workplace emission monitoring carried out and periodical health check-up of associates
- Trained First-aiders and Emergency Response Teams
- HSE Committees at all locations and at the Corporate level
- HSE Audits / inspections
Any incident is followed up on through a structured investigation process and outcome is shared across the locations to avert recurrence.
We are committed to protecting the environment and actively seek to identify means of minimizing water use, energy use, greenhouse gas emissions & waste generation.
We adopt the concept of Green Chemistry through selection of best synthetic route. Raw materials are carefully vetted so as to minimize potential hazards.
Our capabilities in the area of Environment control include:
- Full-fledged and advanced Effluent Treatment Facilities
- Scrubbers for management of process emissions
- Air pollution control devices for stack emissions
- Control measures for fugitive emissions
- Air Handling Units for process areas
- Facilities in place for handling hazardous waste
Careful measurement and monitoring are key steps to continually improving HSE performance, through:
- Data collection and verification
- Internal audits by a cross functional team
- Management system reviews
Employees are encouraged to take an active part in the promotion of HSE.
We recognize that we are part of the communities where we do our work, and strive to focus our efforts into positively contributing by reducing our environmental footprint and achieving sustainable development.