Sunday 31 January 2016

Accuracy Vs Precision in Analytical Method Validation





People are always a little confused about analytical validation characteristics like accuracy, precision, intermediate precision, repeatability and reproducibility. Can some differentiate these to terms?




Accuracy is defined as the degree of exactness, and precision means the degree of reproducibility.




Accuracy
The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness.

Precision
The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three  levels: repeatability, intermediate precision and reproducibility. Precision should be investigated using homogeneous, authentic samples. However, if it is not possible to obtain a homogeneous sample it may be investigated using artificially prepared samples or a sample solution. The precision of an analytical procedure is usually expressed as the variance, standard deviation or coefficient of variation of a series of measurements.

Repeatability
Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision.

Intermediate precision
Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc.

Reproducibility
Reproducibility expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology).
 



Saturday 30 January 2016

New Changes to ISO clean room standards






Revision of ISO clean Room Standards




ISO has a series of standards dedicated to clean rooms, outlining the practices and procedures required to manage the risk of contamination. The first two in the series have just been updated to take into account the latest technological developments and market requirements. Revised clean room standards incorporate best practices for contamination control.

ISO 14644-1:2015, Clean rooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration, and ISO 14644-2:2015, Clean rooms and associated controlled environments – Part 2: Monitoring to provide evidence of clean room performance related to air cleanliness by particle concentration, provide the framework for classifying and monitoring the cleanliness of the air in clean rooms.
The new version includes the following changes:
  • The number of measuring points is no longer calculated as the square root of the surface but given in a table.
  • 5 µm particles for ISO 5 has been dropped from the limit value table.
  • No more statistical UCL calculation: there is no need to perform an observation of all measuring points in the room any longer. Each single measuring point is considered individually and has to meet the limit value.
  • The tubing length to the particle counter should be less than 1 m.
  • The classification number, the sample volumes/ measuring period as well as the cancellation criterion remain unchanged compared to the version of 1999.

The revision of ISO 14644-1 and -2 are so critical to the estimated $14 billion clean room industry.


Thursday 14 January 2016

USFDA – Whistle blower Program




US FDA – Whistle blower Program




A whistle blower is a person who exposes any kind of information or activity that is deemed illegal, unethical, or not correct within an organization that is either private or public. Generally whistle blowers are courageous individuals who recognize a wrong practice and are willing to take risks in order to see that the wrongs are corrected.

In United States’ whistle-blower protection laws incentivise and protect people who expose unethical business practices. The whistle blower program has gained an element of popularity in pharmaceutical sector, because of the generous incentives offered by the US drug regulator which ranges between 10 percent and 30 percent of fines assessed. Ranbaxy Debacle is one of the classic example of US whistle-blower protection.
 


A whistle blower at Ranbaxy USA Inc., a subsidiary of India-based generic pharmaceutical company Ranbaxy Laboratories, received an award of $48.6 million for blowing the whistle on the company’s failure to comply with cGMPs. The drug company’s manufacturing facilities were found to have incomplete testing records, as well as an inadequate program to assess the stability characteristics of its drugs. Such testing is used to determine appropriate storage conditions and expiration dates for the drug, as well as to detect any impurities in the drug. The company failed to file timely “field alerts” with the FDA concerning these violations and agreed to settle the lawsuit for approximately $231 million.

It was Mr.Dinesh Thakur, who had served on the board of the drug firm between 2003 and 2005, approached the US Food and Drug Administration and department of justice with proof that the company had indulged in data tampering, supply of falsified data to the regulator and production and sale of substandard drugs.