GMP News - Analytical Quality Control

23.01.24

The New Ph. Eur. Monographs Cannabis Flower and CBD are now Published

The Ph. Eur. Suppl. 11.5 is now available containing the new Ph. Eur. Cannabis Flower monograph and the new Ph. Eur. monograph Cannabidiol (CBD). The Ph. Eur. CBD monograph now clearly defines: CBD is isolated from the Cannabis sativa L. plant.

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17.01.24

FDA Warning Letter: Missing Stability Studies

In December 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023. According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product.

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10.01.24

The new ECA Guide on Analytical Instrument Qualification and System Validation (AIQSV)

The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. Version 1 of the new document is now available for download free of charge in the AQCG members' area.

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10.01.24

FDA Form 483: Calibration of Analytical Instruments

On 29 November 2023, a new FDA Form 483 that goes back to an inspection in October at a company in India was published. The 23-page report lists a total of 10 observations. Beside others, laboratory equipment including HPLCs, GCs, and UV Spectrophotometers used in commercial release and stability analysis were observed not meeting the calibration specifications.

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10.01.24

ICH Guidelines Q2(R2) "Validation of Analytical Procedures" and ICH Q14 "Analytical Procedure Development" published

After the final texts of the ICH Guidelines Q2(R2) and Q14 were adopted at the ICH Assembly Meeting on 31 October and 01 November 2023, the documents are now available for download on the ICH website.

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10.01.24

EMA/CMDh: Update Q&A Document for Nitrosamines

The current version of the EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", dated October 2023, contains Annex 1 and three further appendices (Appendix 1-3). In December 2023, Appendix 1 was updated and now contains five additional substances.

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09.01.24

Outcome of the AQCG Board Meeting in November: New Board Member and Approval of the AIQSV Guide

The ECA Analytical Quality Control Group (AQCG) met in-person on 20 November 2023 in Düsseldorf/Neuss, Germany. During this Board Meeting, several decisions were made concerning both the composition of the Board and the work program for the coming months.

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13.12.23

FDA 483s due to Deficiencies in the Stability Program: Evaluation of Fiscal Year 2023

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2023. As in previous years, we have again performed an evaluation with regard to deficiencies in the stability programme.

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06.12.23

FDA Warning Letter: Inadequate Testing of BZK and Many General GMP Violations

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. Beside a whole series of general GMP violations, the authority in particular blames the company for failing to test the incoming component benzalkonium chloride (BZK).

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30.11.23

New Ph. Eur. Cannabis Reagents

Following the previously pre-published Ph. Eur. Cannabis Flower Monograph and the announced Ph. Eur. CBD Monograph, four new Ph. Eur. cannabis reagents are needed for quality control purposes. The description of these Cannabis reagents will be published in the European Pharmacopoeia (Ph. Eur.) Supplement 11.5.

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29.11.23

FDA Warning Letter: Lack of Identity Testing and Stability Program

The U.S. Food and Drug Administration (FDA) has sent a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. Based on a review of record, the authority found several CGMP violations. These concern inadequate identity testing of incoming components and finished drug products. Furthermore, an adequate stability testing program was not implemented.

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21.11.23

FDA Warning Letter: Inadequate Quality Systems

The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.

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21.11.23

ICH adopts final Text of Q2(R2) and Q14 Guidelines

The final text of the ICH Q2(R2) Revised Guideline on “Validation of Analytical Procedures” and the new Q14 Guideline on “Analytical Procedure Development” were adopted by the ICH Assembly Regulatory Members.

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21.11.23

News on CEP 2.0: Specifications

The EDQM has once again published further information on its website with regard to the "CEP 2.0". The presentation and content of section 3.2.S.4.1 Specification are now discussed and explained.

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21.11.23

WHO Draft Working Document on Bioanalytical Method Validation published for Comments

The World Health Organization (WHO) has published a draft working document entitled Bioanalytical Method Validation and Study Sample Analysis (QAS/23.925). Comments should be submitted by 21 January 2024.

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