MOD 3 Quality of Assurance for Biotechnology

quality management systems

Quality system

organizational structure that ensures the quality of a prodcut or service. (Company does what it promises)

Quality Systems in Research Labs

Self monitored/Per reviewed. Already inherent quality. will be rejected by community if it is poor quality.

CGMP

General principles that must be observed during manufacturing.

GLP

regulations for animal studies of pharmaceutical products. applies to all nonclinical safety studies supporting new drugs, biologic drugs, , veterinary drugs, some food additives

GCP

For hospital and clinician’s clinical studies on new drugs in humans. Ensure quality of data submitted and protect the welfare of humans during clinical trials

ISO

International Organization for Standardization. Global standards for trusted goods an services

ISO 9000

established fundamentals and vocabulary

ISO 9001

Requirements for ISO certifcation,

ISO 9004

Guidlines of rperformance improvement

ISO 14000

environmental management

What’s the difference between CGMP and ISO

One is federal and required, ISO is voluntary. ISO applies to any kind of organization and CGMP applies to any company producing drugs or medical devices

Six Sigma

improve profitability by reducing variability in processes and product. DMAIC.

Lean Manufacturing

focuses on waste removal. Defective parts, excessive production of parts, excessive inventory, unnecessary activities/steps, unnecessary movement, unnecessary handling of materials, people waiting

5s

Sort, set in order, shine, standardize, sustain

8 fundamentals for quality management

Customer focus, process improvement, Fact based decision making, systems apporach, leadership commitment to excellence, involvement of all employees, continuous improvement, mutually beneficial supplier relationship