Quality Assurance

Quality Assurance

Quality Assurance System is founded on the ICH Harmonised Tripartite Guideline for Good Clinical Practice (GCP), the MHRA guidance for Good Clinical Practices Laboratories, and FDA principles for quality systems.

Quality control procedures are in place to ensure continuous accurate data recording. In addition, comprehensive internal audits of all departments are conducted annually by our independent Quality Assurance Group.

  • System audits
  • Facility audits
  • Quality systems audits
  • Data integrity audits
  • For cause audits
  • Study audits at request
  • Supplier audits
Quality Assurance

Quality Assurance

Precision and reproducibility of analytical data are ensured by regular monitoring of internal Quality Control results as well as by participation in a number of national and international External Quality Assessment Schemes.

Detailed standard operating procedures (SOPs) governing all critical paths are in effect. All staff have documented training records demonstrating the training received, qualifications and education. Our record-keeping practices, both paper and electronic are fully compliant with GCP, and our electronic systems comply with the FDA 21 CFR Part 11.

Laboratory Services

Importance of Quality Assurance in Laboratory Services

Laboratory support is gradually becoming recognised as an important component of disease management and prevention at both the individual and community levels.As a result, there is a need to ensure quality assurance in laboratories at all levels, from central to the most remote, located at primary health care centres.

  • Accurate diagnosis in a patient
  • Implementation of appropriate treatment
  • Prognosis assessment
  • Confirmation of successful treatment
  • Detection of the source of infection
  • Early detection of an outbreak or epidemic

Importance of Quality Assurance

☆  Selection of appropriate chemoprophylaxis for individual patients and the community

☆ Traceability of infection to regulate it

☆ Identification of the impact of outside factors.

Spinos Life Science and Research Private Limited

SpinoS was established with an aim to build a full-fledge CRO offering end to end service with respect the phase studies, with system and process in compliance with global regulatory standards.

Management Of Quality assurance

It ensures that the desired standards are met by the products and services. A lab is essential for quality assurance because it performs the necessary testing and analysis to ensure that products are up to standard. It also aids in identifying areas for improvement, allowing the product or service's quality to be improved. Laboratory management is critical to ensuring that quality assurance is properly managed and that all processes are completed correctly and efficiently.

  • Incorporating internal quality control (IQC) procedures into laboratory practise
  • raining of personnel and use of standard operating procedure manuals (SOPMs)
  • Participation in national or international external quality assessment schemes (EQAS).
  • Purchasing and maintaining appropriate equipment that is compatible with local facilities and needs.
  • Creating a secure working environment in the laboratory
Management Of Quality assurance

At Laboratory Level

☆  Producing consistent, reproducible, and logical results

☆ Optimal use of laboratory resources

☆ All personnel must be committed to and involved in ensuring quality.

whatsapp