Quality Control & Assurance

is one core attribute to which we attach with & give highest priority, and on which we will not compromise. Read about our quality standards here.

Our Quality Vision

Our vision is to globalize, harmonize and simplify GxP processes to ensure a sustainable quality culture. At SPL, we work towards continuous improvement of our Quality Management System (QMS) and all its elements. We are building and maintaining a strong culture of quality through the on-going development, training, and empowerment of our personnel. We believe that producing safe, high-quality product is everyone’s responsibility.

Quality Management System

We ensure its implementation across different functions, including research & development, quality and technical operations. The Quality Manual covers all the quality system elements of the QMS as they are applicable throughout our lines of business. We use the best practices to ensure consistent, high-quality products are delivered to the patients.

Harmonization of Compliance Processes

We have established documentation structure to ensure harmonized processes, methods and strategies throughout the organization. This concept enables planning, monitoring, and facilitating continuous improvement of product quality supporting regulatory compliance.

“Lessons Learned” Strategy

“Lessons Learned” strategy is an integral part of our quality culture. The process includes identification of gaps, their analysis, risk mitigation and taking corrective actions. This approach not only addresses the issues but leads to actions to prevent similar occurrences in the future, and at the same time identifies what went well and how similar processes may benefit from this information.

Quality Metrics

The quality metrics represent a selection of statistical analysis which have been agreed to at a global level. As part of innovation and continuous improvement, the selected quality indicators are monitored, measured and analysed on a routine basis.

Quality by Design Principles (QbD) for Sustainable Quality

The basic concept of QbD is that “Quality cannot be tested into the product, but it should be built into it”. We are implementing a “21st Century Quality Initiative” across the organization including R&D, technical and quality operations to perform quality, risk and knowledge management assessments.

We believe that the key to strengthening the foundation of a responsible brand lies in consistently achieving high standards of quality in everything we do. Quality is embedded at every stage of our operations, including procurement, manufacturing, delivery and safe product disposal. Our focus over the past few years has been to enhance our Quality Management Systems to meet and exceed the current expectations of regulatory authorities such as WHO, DRAP etc.

We’re committed to achieving zero-defect and implement strict quality controls to ensure that every product released from its manufacturing facility adheres to all applicable quality and regulatory standards. This reputation of delivering consistently high-quality products has helped us to be considered as one of the key partners of choice for Government and Non-Government institutions. We conduct regular vendor audits to ensure adherence to relevant quality standards across its value chain. The Quality by Design (QbD) team and Development Quality Assurance (DQA) team work closely with the R&D function to monitor quality during each stage of development.

During the manufacturing process, the Quality Control (QC) team establishes and implements robust practices to ensure quality. Post manufacturing, this is reinforced through safe destruction of defective and expired products as well as stringent pharmacovigilance.

We have successfully overcome challenges such as growing regulatory pressures, demanding compliance requirements and stringent quality standards as a result of our robust Quality Control systems. The Company functions on a business model with a futuristic outlook that envisions the anticipated regulatory developments. This prepares us to adapt readily to the changing environment and ensure business continuity.

ENSURING QUALITY

We understand that adequate and timely investment in strengthening our quality management protocols promise long-term benefits in terms of eliminating cost of failure, enhancing stakeholder confidence and bolstering legal compliance.

We have state-of-the-art manufacturing facilities that are cGMP compliant in conformity with national and international standards. Additionally, GLP has been implemented across the Quality Control and QA Laboratories which significantly improve compliance in our laboratories’ data management as all the instruments are 21 CFR Part 11 compliant. The analytical instrument used for testing of APIs and Pharmaceutical Products include

1. Ultra High Performance Liquid Chromatography (Waters USA)
2. High Performance Liquid Chromatography (Waters USA, Shimadzu Japan)
3. Total Organic Carbon Analyzer (Analytik Jena Germany)
4. Liquid Particle Counter (PMS USA)
5. Fourier Transform Infrared Spectrophotometer (Bruker Germany)
6. UV – Visible Spectrophotometer (Shimadzu Japan, Mettler Toledo Switzerland)
7. Karl Fischer Titrator (Metrohm Switzerland)

Our facilities ensure quality through constant up-gradation of equipment, adoption of technological advances and implementation of industry benchmarked practices. We have developed a robust system to manufacture products that adhere to stringent specifications & in-process controls subsequently leading to high product quality.