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QUALITY CONTROL

Cooper Pharma Ltd is a WHO-GMP and ISO Certified global pharmaceutical company, which has been serving customers in more than 25 countries since 1959. We are USFDA, UKMHRA and TGA compliant and abide by the highest standards of quality.

At Cooper Pharma, our mission is to provide reliable, safe and affordable medicines to patients worldwide, thus helping people to live healthier lives. Right from the procurement to the completed formulations, our stringent procedures ensure that the products are safe, effective and compliant with the International standards.

Efforts are underway to get our fully equipped laboratories accredited as the Research & Development Center by the Government of India.


QUALITY POLICY

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Our quality policy stands committed to maintaining the good manufacturing practices, conform to the International standards and ensure a timely supply of goods with cost-effectiveness. We believe in achieving the highest level of customer satisfaction and market leadership in domestic, as well as overseas markets, by implementing the Quality Management Systems (QMS) on a continual basis.

QUALITY CONTROL

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Quality control begins at the time of material planning and continues through the process of receiving the APIs and other material for the production, which is sourced from approved, reputed vendors. The process of monitoring the stability of the product during the shelf life continues until the release of the finished goods for sale and expiry of the product.

We have an in-house modern testing laboratory, which is equipped with all the necessary instruments and a highly-qualified technical staff. An area of over 10,000 sq ft and a team of over 25 skilled employees is dedicated especially for QC activities.

With an aim to preserve the high quality of the products, we do not compromise on the APIs. We import quality raw materials from reliable sources in Germany, Italy, and other European countries. We operate in total compliance with the G.M.P. norms set by the W.H.O. and the latest international guidelines set by the USFDA/ UKMHRA/ EUGMP. These norms are controlled by superior quality laboratories that are divided into three sections:

• Chemical Laboratory: Has adequate, qualified technical staff and well-laid out Standard Operating Procedures (SoPs) for operation

• Instrumentation Laboratory: The fully equipped QC department has the latest state-of-the-art equipment, such as 6 HPLCs, 2 IRs, GCs, ToC, 4 stability chambers & incubators among instruments

Microbiological Laboratory: The products are subjected to a series of microbial tests during production and post production. The environment and utilities are continuously monitored on a real-time basis here.

We have achieved many awards and acclamations at the state, national and international levels for keeping our promise of excellent quality.

 

QUALITY MANAGEMENT & ASSURANCE

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We use ultra-modern technology and strict operating procedures. The technically skilled team maintains the highest standards of safety and utilizes environmentally-friendly and clean processes for quality management.

We have received approvals from various ministries of health & regulatory agencies for the sales & distribution of our products.

Key elements for effective quality controls

• Our state-of-the-art manufacturing facilities are cGMP compliant (current Good Manufacturing Practices) and conform to national and international standards. Our hi-tech machineries are designed to achieve a high level of precision.

• Our quality control laboratories have the latest equipment that offer excellence at every stage of processing. We have a dedicated pool of talent that consistently retains the safety standards.

• We maintain world-class quality for our products and services across domestic and overseas markets, thus ensuring that every patient has access to the best medicines in the world.

• We upgrade our manufacturing facilities, adapt to the technological innovations and provide medicines at an affordable price.

NEW DRUG DISCOVERY

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Formulation research and development is carried out by experienced scientists, technicians, and chemists. The team specializes in creating alternate processes for generic formulations. It is equipped to conduct the following processes for formulation development:

• Product and process optimization

• Analytical method development

• Analytical method validation

• Evaluation and techno-marketing studies

• Technology transfer

Our team of scientists is equipped to create the best combination of materials and manufacturing methods. These experts have a pre-formulation insight and proficient knowledge in pharmaceutical ingredients.

The facility is geared towards the development of technologically challenging products. Over the years, our team has created several distinctive items, delivery methods, and latest formulations, which help patients recover faster. Some examples of value-added generics include dispersible tablets, chewable tablets, extended-release tablets, multi-layered tablets, etc.