Quality Control

• 

• Quality Control Policies

  A key component in quality control in pharmaceutical industry is helping customers by providing a quality product. We achieve this by ensuring that all our facilities operate efficiently and to the latest quality, safety, and productivity standards.

  An integrated API quality control development approach and quality by design (QbD) principles have been adopted to develop a robust and scalable manufacturing process for consistent quality profile and effective process development with high-quality standards to meet regulatory requirements. By implementing current good manufacturing practices (CGMP) across our API manufacturing sites, we can produce high quality products and supply to our customers as per global requirements.

• 

• Quality Management

  Dr. Reddy’s has continued to manufacture and deliver APIs following global regulations because of the processes and the analytical methods developed by our experts to avoid nitrosamine and azido impurities and follow stringent quality control of drugs and pharmaceuticals. We stay committed to ensuring that we continue to provide high-quality and safe APIs to our partners.

  An extensive range of analytical techniques elucidate and demonstrate the chemical and physical attributes. All the potential and degradation impurities are thoroughly evaluated, identified, characterized, and controlled to meet the quality standards of the APIs as per the ICH guidelines.

• 

• Quality Assurance

  The pharmaceutical quality assurance (QA) team at Dr. Reddy’s continually monitors various facets of the quality management system. We are committed to maintaining highest quality standards in cGMP manufacturing through periodic reviews and continuous improvement of quality management system. All our manufacturing units have undergone multiple cGMP audits by various regulatory authorities, and numerous quality audits by various customers. As a result, our high-quality APIs meets all the formulation needs for various global markets.

• 

• Review Meetings in terms of Quality control

  With continuous monitoring through regular internal review meetings, cross functional audits, knowledge transfers, and harmonization of procedures across the organization. As a result, we are able to maintain and update our quality system. All our API manufacturing units are operated in accordance with cGMP regulations. Our customers recognize us for our proven regulatory track record including Drug Master File (DMF) or Chemistry, Manufacturing and Controls (CMC) section, Investigational New Drug Application (IND) and New Drug Application (NDA) filing, and deep experience with regulatory authorities such as the USFDA, WHO GMP, KFDA, PMDA, Health Canada, ANVISA and European Medicines Agency (EMA).