Quality Leadership and Excellence by Design
At Alta, our mission is to provide good quality of APIs to our global customers that help people lead healthier lives. Our philosophy and intent are to create and maintain world-class business practices to ensure that our products are safe, effective and compliant with all internationally defined good practices. Our passion for quality goes beyond business and statutory requirements. We have only one focus –end user should be satisfied with our quality.
We are committed to fulfilling the spirit and intent of our Quality Philosophy at Khopoli location where we conduct regulated research, development, manufacture, testing and/or distribution of API products. Our objective is sustained compliance with internationally defined good practices includes current Good Manufacturing Practice (cGMP), ICH Q7, WHO guidelines and Good Laboratory Practice (GLP), SHE ( safety, health and environment ) policy.
We partner with our business partners to assure high quality development, manufacture and distribution of reliable and safe products through
- Qualified, responsible, and motivated employees
- Integrity of our behavior and actions
- Effective and efficient compliant quality systems
- Continuous quality improvement
Each of us is dedicated to contributing to the process of developing, manufacturing and distributing the company’s products in a manner that meets the safety, efficacy and compliance expectations of both customers and Government regulators.
- Our Quality policy states that “Better quality for better tomorrow”.
- Individual Responsibility – Quality is a part of our culture at Alta. Every employee is focused on quality.
- Management Responsibility – Management allocation of appropriate resources for effective implementation of all required quality management systems designed to support and sustain a culture of continuing GMP compliance and operational excellence.
- Accuracy and Ethics – Every employee shall generate and accurately document all required quality data in accordance with the highest ethical standards and Alta’s Code of Conduct principles.
- Continuous Improvement – Quality performance indicators shall be measured and assessed with outcomes designed to drive continuous improvement in our quality systems and employee performance.
Our quality organisation is independently structured and resourced to fulfill organisational responsibilities and objectives as defined by our quality management system to ensure the achievement of established product quality standards. Quality Management System Our quality system comprises both Quality System Controls and Quality Management Controls.
Our quality system comprises both Quality System Controls and Quality Management Controls.
Key elements for Quality System Controls include
- Facilities and Equipment System
- Materials System
- Production System
- Packaging and Labeling System
- Laboratory Controls Systems
- Quality Systems
Quality Management Controls
Quality Management Controls enable us to proactively analyse and manage the performance of our quality system. Our Quality Management Controls for
- Resource Management
- Employee Training
- Quality and Compliance Data Trending and Analysis
- Quality System Management Review
- GMP Document Management
Manufacturing
Alta understands the critical necessity for quality APIs and works hard to ensure that customers receive products of the highest standard. Thus, the Alta family adheres to stringent policies through each step of the production process. Our manufacturing facility meets cGMP requirements and has been given the GMP Certification by the State Drug Control Authority. All our manufacturing facilities employ the latest technologies and make use of modern plant and machinery in the production process.
We have fully equipped in-house testing facilities where-in rigorous quality and testing standards are applied before an input goes into production of APIs. It undergoes inspections by Alta staff under a self-inspection plan and annually the areas are frequently audited, inspected, and approved by our business partners and overseas business partner where we export to. The manufacturing process begins with the careful selection of raw materials that are processed under completely hygienic conditions. All the processes are regularly validated, calibrated and upgraded as and when necessary. Quality control is a rigorous, painstaking process by itself, followed religiously for every product.
Alta is continuously investing in the latest equipment to ensure that our manufacturing facility is enhanced with modern, state of the art technologies. Our employees are trained and assessed by experienced professionals from all over the world to hone their skills and gain expertise on cutting edge techniques. In this way, each APIs is produced with precision to provide you and your loved ones superior products.