Analytical Quality Control News

Lack of OOS investigation leads to FDA Warning Letter

Chinese manufacturer of active pharmaceutical ingredients Jilin Shulan Synthetic Pharmaceutical received an FDA warning letter in May 2018. It was criticised in particular that the Company did not record, investigate and solve laboratory OOS results. It was also criticised that the Audit Trails of the electronic laboratory instruments (HPLC, GC, IR) were not enabled. Find out more about the Jilin Shulan Synthetic Pharmaceutical Warning Letter.

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Must each container of a starting material be sampled for identification?

This question has been adopted by Health Canada in their "Good Manufacturing Practices (GMP) Questions and Answers". Read here, what recommendations the Canadian authority gives for sampling APIs and excipients.

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FDA Warning Letter due to not functioning HPLC Audit Trail

The Chinese API manufacturer Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. received an FDA warning letter in April 2018. During the FDA inspection, the deletion of electronic data of HPLC and GC analyses and the mulfunctioning of the Audit Trail of the laboratory instruments were particularly criticised.

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Quality Risk Management: What Inspectors are looking for

ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?

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Can the (√n+1) Rule be accepted in Sampling Plans?

Is a sampling plan based on the (√n+1) rule acceptable for determining the correct number of samples? Health Canada took up this question in their "Good Manufacturing Practices (GMP) Questions and Answers". Read more under which conditions the use of sampling key (√n+1) is possible.

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ECA Data Integrity Task Force issues Version 2.0 of Data Integrity Guide

With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.

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FDA Warning Letter due to Faulty Sampling

Drug manufacturer Shanghai Weierya Daily Chemicals in China received an FDA Warning Letter in February 2018. During the inspection, the inadequate sampling when testing active pharmaceutical ingredients and excipients was criticised. Read more about the recent Shanghai Weierya FDA warning letter.

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Measurement Uncertainty for the Pharmaceutical Industry

The USP recently published a stimuli article regarding the discussion of measurement uncertainty (MU) which is a component of the lifecycle approach to analytical procedures. Read more about the USE OF MEASUREMENT UNCERTAINTY IN THE PHARMACEUTICAL INDUSTRY.

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Warning Letter due to Non-Compliance with Specifications

Drug manufacturer Shanwei Honghui Daily Appliance in China has received an FDA Warning Letter in December 2017. During the review, the FDA criticised the company's failure to check certificates of analysis for compliance with the specifications. Find more information in the recent FDA Warnig Letter to Shanwei.

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FDA Warning Letter due to Non-Compliance with Specifications

The Indian drug manufacturer Kim Chemicals received an FDA Warning Letter in October 2017. During an FDA inspection, it was criticised that not all medicinal products and the active substances they contained had been tested for compliance with the specifications. Find out more about the Kim Chemicals FDA Warning Letter.

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