GMP News - Analytical Quality Control


FDA warning letter due to non-compliance with specifications and ID testing

Drug manufacturer IDT Australia Ltd. received an FDA warning letter in May 2018. It was criticised during the FDA inspection that OOS results of assay determinations had not been investigated and that a batch had been released even though three consecutive identity tests had failed. Read more about the IDT Australia FDA warning letter here.



Revised FDA Guidance on the validation of analytical methods

After five years and thorough revision, the FDA Guidance "Bioanalytical Method Validation" has been finalised. Read here what requirements the FDA lays down for a completely validated bioanalytical procedure.



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.



New ICH Guidelines: ICH Q13 on Conti Manufacturing and ICH Q14 on AQbD

In a press release from 22 June 2018 the International Council for Harmonisation (ICH) has announced that they will prepare new topics for the future that are of great importance for the pharmaceutical industry. The Council intends to begin developing the ICH Guidelines Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14)" and "Continuous Manufacturing (Q13)". Find out more about this important ICH Press Release.



New USP Chapter on Moisture Barrier of Plastic Packaging Systems

The USP published a draft of a new general chapter on the Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems. Additionally the general chapter Containers—Performance Testing <671> has been revised and published for comment in the same issue of PF.



Packaging materials: DIN standard on migration published

Together with project partners from industry and research & development, five associations have agreed on a testing method for evaluation of migration from paper and paperboard. Read more about the migration standard.



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.



Warning letter due to non-validated Analytical Methods

Procedures for the analysis of GMP-liable products must be validated. Read here, what deficiencies involving the validation of analytical methods and the handling of OOS results almost inevitably lead to a Warning Letter.



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.



Revised Ph. Eur. Monographs on Excipients due to ICH Q3D

Several Ph. Eur. Monographs on excipients used in semi-solid formulations have been proposed for comment. Read more about the monographs on oils, fats, waxes, emulsifiers.



New USP Chapter <1210> Statistical Tools for Procedure Validation

The final USP General Chapter <1210> has been published. It will become official on May 1, 2018. Read more about  Statistical Tools for Procedure Validation.



Ph. Eur. Packaging Chapters adopted

Several revised Ph. Eur. packaging chapters have been recently adopted by the Ph. Eur. Commission. These general chapters will appear in Ph. Eur. 9.6. Read more about the revised chapters on plasticized PVC materials and glass containers.



New USP Chapter <922> Water Activity

The United States Pharmacopeia, USP, posted the announcement of the elaboration of a new general chapter <922> on Water Activity.



Warning Letter for systematic invalidating of OOS Results

If inspectors find deficiencies in quality control, they usually make sure to go into detail. Find out in which cases the invalidating of OOS results and exceeded bulk hold times are not tolerated in FDA inspections.



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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