GMP News - Analytical Quality Control


FDA Warning Letter: No Adequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.



FDA Warning Letter for not Adequately Testing Components prior to Use in the Manufacture

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.



Pyrrolizidine Alkaloids: USP Proposal for Contaminant Analysis

In addition to the new USP Chapter <1567> Pyrrolizidine Alkaloids announced recently, the USP is proposing a new chapter entitled <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs).



2-Step Process for Implementation of Pharmacopoeial Procedures

A new Ph. Eur. draft chapter 5.26 proposes a two step implementation process for the use of pharmacopoeial procedures.



Herbal Medicinal Products: HMPC's Statement on Pyrrolizidine Alkaloids

The Herbal Medicinal Products Committee (HMPC) of the EMA has published the draft of the updated public statement of the HMPC on pyrrolizidine alkaloids (PAs). The document contains, among other things, the limits for the maximum daily intake of PAs.



Eurasian Pharmacopoeia Available

The Eurasian Economic Commission published Volume 1 of the EAEU Pharmacopoeia. This Volume contains 157 general texts and general monographs.



New USP Draft Chapter on Plastic Components Used in Manufacturing

In the current Pharmacopeial Forum revised drafts of the two previously published USP Chapters <665> and <1665> on plastic materials used in pharmaceutical manufacturing have been published for comment.



USP publishes draft of new chapter <1220> Analytical Procedure Life Cycle

The USP published the long awaited draft of the new chapter on the Lifecycle of Analytical Methods in the Pharmacopoeal Forum.



Questions & Answers: Semi-Automated Visual Inspection

The webinar on semi-automated visual inspection of parenteralia on June 16, 2020 met with great interest. In addition to many basic questions regarding visual inspection, specific questions about semi-automated inspection were asked and answered during the webinar. Here you can find a short selection.



A Lifecycle Approach for Analytical Instrument and Systems Qualification

In July 2018, the ECA Analytical Quality Control Group published version one of its guideline on Analytical Procedure Lifecycle Management (APLM) in support of the development of USP <1220> and the ICH revision of Q2(R2) and the newly proposed Q14.



Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a firm that manufactures and distributes OTC products. The Warning Letter summarizes significant violations of current Good Manufacturing Practice (CGMP). The company failed, amongst others, to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. Furthermore, the laboratory management could not provide an adequate explanation for several unofficial HPLC injections.



Herbal Drugs: USP Proposes New General Chapter on PAs

USP´s Expert Committee for Botanical Dietary Supplements and Herbal Medicines proposes a new general chapter on Pyrrolizidine Alkaloids (PAs).



Mexican API Manufacturer receives Warning Letter

The US Food & Drug Administration (FDA) explicitly explains the deficiencies in the area of quality control in its Warning Letter for the company "Signa SA de CV".



FDA Warning Letter to Homeopathic Product Manufacturers due to Quality Issues

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.



FDA Warning Letter: Lack of Lab Data Integrity

Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.


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