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Quality Leadership and Excellence by Design

At Modern Laboratories, our mission is to provide trusted medicines 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 – Patients.

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

We are committed to fulfilling the spirit and intent of our Global Quality Philosophy at all locations where we conduct regulated research, development, manufacture, testing and/or distribution of pharmaceutical products. Our objective is sustained compliance with internationally defined good practices, collectively known as GxP. This includes Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GPVP).

Our commitment to GxP regulatory excellence supports our objective of providing safe and efficacious pharmaceutical products to our customers worldwide. Our alignment with these standards provides the assurance that patient safety is protected and that the data provided to the regulators is of the highest accuracy, integrity and quality.

Quality Mission Statement

We partner with our stakeholders to assure high quality development, manufacture and distribution of reliable and safe medicines through:

  •                Qualified, responsible, and motivated employees
  •            Integrity of our behaviour and actions
  •            Effective and efficient GxP 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 medicines 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 Global Quality Policy:

  •    Individual Responsibility – Quality is a part of our culture at Modern Laboratories. Every employee is focused on quality
  • $1·         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 GxP 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 Modern Laboratories’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 global quality organisation is independently structured and resourced to fulfil organisational responsibilities and global objectives as defined by our quality management system to ensure the achievement of established product quality standards.

Quality System Management

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 drug 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 Labelling System
  •          Laboratory Controls Systems
  •          Quality Systems

Quality Management Controls

Quality Management Controls enable us to proactively analyse and manage the performance of our global quality system. Our Quality Management Controls include QA/GxP processes for:

  •          Resource Management
  •          Employee Training
  •          Quality and Compliance Data Trending and Analysis
  •          Quality System Management Reviews

GxP Document Management

Our global document management hierarchy is outlined in the pyramid shown below:

Inclusive and Motivating Principles

We ensure that 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 Global 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 all our facilities continue to meet the exemplary standards that are expected of a global pharmaceutical company.