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 guarantee 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 right from the procurement of APIs to the distribution. The predefined Standard Operating Procedures are strictly implemented to meet cGMP norms formulated by the National and International Regulatory Bodies. Our laboratories are equipped with modern and necessary instruments and qualified staff. Our QA and QC professionals make sure that standard guidelines are followed and the product quality is uncompromised. Therefore, 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 emphasizes on quality aspects of every product being manufactured at the facility. We are committed to comply with the quality standards set by the USFDA, UKMHRA and TGA. We are a WHO-GMP and ISO 9001:2000 certified medicine manufacturing company and have a very strong and robust QA/ QC infrastructure with a strong focus on quality and efficacy. Therefore, we ensure that our medicines efficiently qualify the predetermined quality norms 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 processand subsequent shelf life of the product. We also take steps for raising 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
Quality 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 specialized to operate modern lab equipments to test the quality and efficacy 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 & Quality Optimization
Quality optimization is a continuous process that we always take care of. It is necessary to optimize product quality at a reduced cost. The installation of any new process, facility, system and/or equipment is a part of this optimization. It is achieved through certain steps like:
- Technology transfer
- Analytical development
- Evaluation process
- Innovative developments
- Automation installation
Our researchers and technical staff use the best possible equipments and manufacturing methods to deliver international standard products. Moreover, new device/equipment/machinery is examined through Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) before making it a part of the production process. 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.