Auditing an Analytical Quality & Stability Testing Laboratory sample

ثبت نشده
چکیده

• Understand what the GMP requirements are for the analytical quality laboratory and stability testing laboratory • Identify which GMP regulations govern the analytical quality laboratory • Use a range of information tools, from the contents of this training in support of analytical testing and stability testing auditing. • Recognize compliance or non-compliance of analytical quality laboratory and stability testing

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Harmonization of laboratory testing - Current achievements and future strategies.

Harmonization in laboratory testing is more far-reaching than merely analytical harmonization. It includes all aspects of the total testing process from the "pre-pre-analytical" phase through analysis to the "post-post-analytical" phase. Harmonizing the pre-analytical phase requires use of standardized operating procedures for correct test selection, sample collection and handling, while standa...

متن کامل

Determination of the Rate and Reasons of Blood Sample Rejection in the Pre-Analytical Phase in Ruhengeri, Rwanda: A Single Center Study

Background and objectives: All three phases of laboratory testing are equally important for improving total quality management, but the pre-analytical phase is the most error-prone. This study aimed to determine the rate and reasons for blood sample rejection in the pre-analytical phase of laboratory testing in a referral hospital in Ruhengeri, Rwanda. Methods: This study was a cross-sectional...

متن کامل

Process capability and stability of analytical systems assessed from proficiency testing data.

Participation in a proficiency testing (PT) program is a valuable adjunct to laboratory activities dedicated to the maintenance of reliable analytical methods. The PT program may facilitate continuous quality improvement if laboratory performance is presented in the context of expectations espoused by healthcare professionals for optimal patient care. Statistical process control (SPC) and capab...

متن کامل

Application of Statistics to Evaluate Iranian Analytical Laboratories Proficiency: Case of Aflatoxins in Pistachio

The aim of this study was to evaluate the utility of a proficiency testing program among limited number of local laboratories as an alternative to the IUPAC/CITAC guide on proficiency testing with a limited number of participants, specially where international schemes are not accessible. As a sample scheme we planned to determine aflatoxins (B1, G1, B2, G2, total) in Iranian pistachio matrix. A...

متن کامل

Preanalytical variability: the dark side of the moon in laboratory testing.

Remarkable advances in instrument technology, automation and computer science have greatly simplified many aspects of previously tedious tasks in laboratory diagnostics, creating a greater volume of routine work, and significantly improving the quality of results of laboratory testing. Following the development and successful implementation of high-quality analytical standards, analytical error...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره   شماره 

صفحات  -

تاریخ انتشار 2013