Every manufacturer must ensure their suppliers provide products that are fit for purpose throughout the product lifecycle, from design and development through to supply to the end-user.
Our Quality Services team is responsible for quality-related elements of Customer Inquiries and Customer Communication. We partner with our Technical and Customer Services teams to ensure a seamless support network. In addition, we push industry standards forward and add value to our customers by providing superior quality and regulatory services.
Our customers have different regulatory environments, applications, and documentation requirements. To meet these needs for our products, we provide:
Certificates of Analysis
Safety Data Sheets
Quality Declarations are issued upon customer, business or authority request and are primarily used for our customers’ product-specific risk assessment. The customer is responsible for ensuring the products are suitable for their intended use.
Customer Quality Management is an integral part of our commitment to quality and encompasses all manufacturing sites. Our mission is to support our customers by providing accurate and value-added responses to customer concerns and issues in a timely manner. One of the key components of our Customer Quality Management program is addressing customer issues, experiences and complaints.
Quality Management Reviews are conducted at planned intervals to ensure the continued suitability, adequacy and effectiveness of the Quality Management Systems.
The Quality Manual describes the basic requirements for implementation, maintenance, and improvement of our Quality Management Systems at every level of our organization. The implementation of the Quality Manual ensures the ability to consistently provide products and services that meet or exceed customer, statutory and regulatory requirements.
Training is conducted to ensure the qualification and the competencies of all employees to current and future responsibilities. Training is conducted by qualified individuals on a continuing basis.
We have quality management system to utilize all core business processes, such as Complaint, Change, Deviation and Audit/CAPA management. By implementing QMS .we have built up database for all Quality Processes. Clear roles and responsibilities in streamline workflows optimize efficiency in the daily management of all quality aspects and guarantee full transparency of all current and past events..
Quality Risk Management is consistent with the process outlined in ICH Q9. Risk management is based on scientific knowledge. Continuous improvement is accomplished through the process of collection, monitoring and analysis of quality performance indicators, and is focused on product quality, regulatory compliance, customer satisfaction, resource allocation and subcontractor/supplier management.
Corporate audits, Internal audits and self-inspections are regularly performed across the company to verify compliance with external and internal standards and procedures, identify areas for continuous improvement, and highlight best practices.
Our approach to compliance
Compliance is one of our primary considerations worldwide. As a company with operations in developing, we have extremely stringent requirements for effective compliance management. For us, however, there is more to compliance than simply adhering to regulatory provisions. We consistently aspire to act in accordance with the principles defined in our Values and believe that profitability should go hand in hand with the highest ethical standards.