Quality Assurance

Pharmaceutical, Quality Assurance Testing Laboratory in India

Quality Assurance, an undeniable field, may affect a drug’s quality during its research, development, manufacturing, and sales phases. QA is essential for ensuring that pharmaceutical products that are manufactured to a safe and consistent standard in the pharmaceutical industry.

We have a dedicated Quality Assurance Department to ensure that your projects will receive the highest level of quality by implementing Quality Management Systems. Our Quality Assurance Department is equipped with a comprehensive set of standard operating procedures. Our quality assurance team has the competency of predicting and preventing all non-compliances at the early stages of development to ensure data integrity and accuracy. Our quality assurance team has the approach to implement the quality management system by understanding the need for required compliance as per regulatory requirements.

This department is completely independent and provides support to project teams to conduct high-quality clinical research. QA departments often assist in laying down standards, identifying service providers to be audited, for instance, laboratories, drug packaging, and supply vendors. They have all the required technical expertise to ensure that the appropriate quality systems are in place to provide utmost data quality and integrity in accordance with ICH GCP, Protocol, SOP, and regulatory requirements.

QA departments also identify the internal procedures of the trial that will be audited from initial study design, site and data supervision, statistical evaluation, and the final CSR. This is accomplished by internal audits coupled with site audits to ensure compliance with ICH GCP, Protocol, SOP, and regulatory requirements.

We are specialized in managing the following quality assurance activities during the entire project management cycle:

  • Management of The Quality Systems
  • Conduct and Reporting of Clinical Trial on Site Audits
  • Vendor Qualifications
  • Conduct and Reporting of Mock Regulatory Onsite Inspections
  • Investigator Training for Management of Inspections by Regulatory Agencies
  • SOP Preparation
  • CAPA Implementation and Compliance