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.

Our commitment to implementing a robust, quality management system is based upon our desire to sustain a culture of operational excellence, meeting and exceeding the expectations of all global customers and Government regulators.

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.

Quality Mission Statement

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

Quality Management Principles

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.

We adhere to the following principles when implementing our Quality Policy

  • 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.

Quality Organisation Structure

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.

Quality Management System

Our quality system comprises both Quality System Controls and Quality Management Controls.

Quality System Controls

Quality System Controls assure that the development, manufacture, release and distribution of products take place through well-defined and well-documented quality systems and procedures.

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

GMP Document Management

Our document management hierarchy is outlined in the pyramid shown below.

Inclusive and Motivating Principles

We ensure the processes of our business partners comply with national and international regulatory standards that are in alignment with those of our own. We have implemented a well-defined and thoroughly documented set of quality systems and procedures for our business partners.

Quality means continuous improvement. Our Quality Standards are constantly benchmarked against best practices and so these are continually upgraded to keep pace with the changing dynamics of the global environment.

We remain committed to the highest levels of professionalism and integrity and will ensure that our facility continue to meet the exemplary standards that are expected of a global pharmaceutical company.