Quality System
Quality at Cooper Pharma
At Cooper Pharma, quality is embedded in every step of our operations, from research and product development to manufacturing and delivery. We adhere to stringent Quality Control and Quality Assurance protocols, ensuring each product meets global standards for safety, efficacy, and reliability. Our dedicated policies and innovative practices drive continuous improvement, while rigorous validation processes ensure consistent performance. By integrating advanced technology with skilled expertise, Cooper Pharma delivers pharmaceutical products that healthcare professionals and patients can trust. Our commitment to excellence underpins every product, reflecting our promise of safe, effective, and high-quality medicines worldwide.
QC Focus
Quality Control
Cooper Pharma follows a firm quality control system that applies at every phase of the production process from the procurement of raw materials (APIs and excipients) through to distribution. The predefined Standard Operating Procedures are strictly implemented to meet cGMP norms set by national and international regulatory bodies. Our laboratories are equipped with modern instruments and staffed by qualified analysts. Our QA and QC professionals make sure that standard guidelines are followed and the product quality is uncompromised. All testing and evaluation activities are carried out in a controlled environment to ensure safety, effectiveness, purity and strength of the products before they reach the end users.
Advanced analytical instruments and validated methods ensure consistency, safety, and efficacy of every batch manufactured.
QA Excellence
Quality Assurance
Cooper Pharma always emphasises quality in every product manufactured at the facility. Our quality systems are aligned with WHO-GMP and international cGMP guidelines. We are a WHO-GMP and ISO 9001:2015 certified medicine manufacturing company and have a robust QA/QC infrastructure with a strong focus on quality. Therefore, we ensure that our medicines consistently meet predetermined specifications and remain safe, effective and acceptable throughout the shelf life.
Our QA team ensures that each product, process, and system remains compliant with international quality and regulatory standards at all times.
Our Commitment
Quality Policy
Cooper Pharma has implemented the standard Good Manufacturing Practices, Good Laboratory Practices, Good Documentation Practices and Monitoring guidelines throughout the manufacturing process and subsequent shelf life of the product. We also take steps to raise quality standards through our research activities keeping customer satisfaction in mind. There is an established Quality Management System (QMS) that helps us in consistently maintaining product quality in every phase of production.
Our Quality Policy drives every decision – from sourcing to manufacturing and distribution – ensuring consistent quality for patients worldwide.
Innovation Driven
Product Innovation
Like many other world-class WHO-GMP pharmaceutical companies, Cooper Pharma also believes in investing in research and development of new formulations to treat diseases more efficiently and effectively. We have a team of scientists and technicians who are trained to operate modern laboratory equipment to test the quality and performance of new and generic formulations.
By integrating innovation into quality, we optimize product performance and deliver better outcomes for patients and healthcare providers.
Validated Systems
Validation & Optimization
Quality optimisation is a continuous process at Cooper Pharma. The installation of any new process, facility, system and/or equipment is part of this work. It is achieved through:
- Process validation
- Cleaning validation
- Analytical method validation
- Equipment qualification
- Technology transfer
Our researchers and technical staff use the best possible equipment and manufacturing methods to deliver international-standard products. Moreover, all new equipment is qualified through Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) before it is released for production. We always strive for total customer satisfaction through continuous improvements in processes and systems.
Our validation and optimization activities ensure that every system, process, and product consistently delivers the intended quality throughout its lifecycle.