What are the WHO guidelines for quality control laboratory?
2.1 The laboratory or organization management should establish, implement and maintain a quality management system appropriate to the scope of its activities, including the type, range and volume of testing and/or calibration, validation and verification activities it undertakes.
What is quality control guidelines?
Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. QC is similar to, but not identical with, quality assurance (QA).
How do you do quality control in a lab?
Other ways of managing quality control include peer testing and alternative monthly review of QC trends. Clinical laboratories are frequently enrolled in clinical laboratory proficiency testing (PT) programs that are used to validate their testing protocols.
What are CGMP guidelines?
The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
What are the good practices in quality control?
To help you get started, follow these quality control best practices for automating, inspecting, and tracing products from start to finish….3. Trace
- Provide timely reporting.
- Track supplier performance.
- Troubleshoot quality problems.
- Predict patterns.
- Improve production scheduling.
- Increase customer service levels.
What are the 3 main objectives of quality control?
Following are the important objectives of quality control: 2. To discover flaws or variations in the raw materials and the manufacturing processes in order to ensure smooth and uninterrupted production. 3. To evaluate the methods and processes of production and suggest further improvements in their functioning.
What is QC sample?
Quality control samples are special specimens inserted into the testing process and treated as if they were patient samples by being exposed to the same operating conditions. …
What are the two methods of quality control?
This article throws light upon the top two methods of quality control. The methods are: 1. Inspection 2. Statistical Quality Control (SQC).
What are the requirements for laboratory quality control?
General requirements for testing laboratories can be found in ISO/IEC 17025. JULY 2004 18-1 MARLAP Laboratory Quality Control This chapter addresses the control of the analytical process in the laboratory, as distinct from meeting the typical analytical needs of a specific project.
Are there government regulations for a QC laboratory?
Dr. Sharon Ehrmeyer returns with an section for our Basic QC Practices series. If you’re operating a laboratory in the U.S., there’s a government agency out there that wants to regulate you – do you know which one? In this article, Dr. Ehrmeyer details all the various bureaucracies and their regulations.
What are the regulations for clinical laboratory testing?
One way or another, you have to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88), which establish the minimum standards for all laboratory testing, including specific regulations for quality control [1].
Are there any specific requirements for a QC test?
No specific QC requirements are identified. Good laboratory practice would dictate that controls be run and results documented and reviewed for correctness before reporting patient results. The tests that are waived include the following (current September 29, 1997 list of Waived Tests):