GMP News - Analytical Quality Control

16.03.22

Proposal for Slightly Revised USP Chapter <711> Dissolution Published

In the Pharmacopeial Forum, PF 48(2), a proposal for a slightly revised Chapter <711> Dissolution was published. The purpose of the revision is to include an option of using a new USP Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.

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09.03.22

USP: Second Stimuli Article on Instrument Qualification published for Comments

In the beginning of March 2022, the stimuli document "Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification - The Role of Measurement Uncertainty Concepts within the AIS - PF 48(2)" has been published on the USP Pharmacopeial Forum website for comment.

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09.03.22

USP: Proposed Addition to Chapter <1236> Solubility Measurements

It is proposed to add the porcine simulated gastric and intestinal fluids in the subchapter on solubility measurements in biorelevant media. The new version of the chapter has now been published in the Pharmacopeial Forum, PF 48(2) for public comments.

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02.03.22

Plastic Components Used in Manufacturing: USP extends Official Date for <665>

To address inquires and to give USP more time to engage with stakeholders regarding the suitability of making <665> an applicable general chapter, the USP intends to extend the official date for <665> to May 1, 2026.

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02.03.22

WHO publishes Draft Working Document on Chromatography

The World Health Organization (WHO) has published a proposal for a new chapter 1.14.1 Chromatography for inclusion in The International Pharmacopoeia. Comments on this draft working document can be submitted until 25 March 2022.

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16.02.22

What is a 702(b) Portion?

The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled Collecting and Providing 702(b) Portions of FDA Official Samples. The draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act).

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02.02.22

FDA Warning Letter: Combination of Returned Capsules from Various Lots into New Batches

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian drug manufacturer. During an inspection, it was observed that the firm combined returned capsules from various lots into new batches, resulting in new lots with no uniform character and quality. The FDA also criticizes the firm’s stability programme and validation activities.

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02.02.22

Dissolution Testing in Pharmaceutical Analysis (Part 3)

The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. This article provides a brief overview about the automation in dissolution testing.

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26.01.22

Inadequate OOS Investigations lead to FDA Warning Letter

Recently the U.S. Food and Drug Administration (FDA) issued a warning letter due to inadequate investigations into out-of-specification (OOS) test results.

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26.01.22

USP: Analytical Instrument Qualification Stimuli published for Comments

Since the beginning of 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" has been published for comment on the USP Pharmacopeial Forum website.

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25.01.22

Proposal for New General USP Chapter on Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides

In the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> was published. According to the Expert Committee, the aim of the new chapter is to provide an overview of the minimum quality attributes required for starting materials used in the manufacture of synthetic therapeutic peptides.

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19.01.22

Approved USP Chapters on Plastic Components used in Manufacturing

The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.

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12.01.22

New Ph. Eur. Draft for COC

A revised draft for the new Ph. Eur. chapter 3.1.17. Cyclo-Olefin Copolymers (COC) has been published for comment in Pharmeuropa.

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15.12.21

Herbal Reference Standards - What are Active and Analytical Markers?

Active and analytical markers are used  for release and stability testing of herbal substances, preparations and HMPs. The EMA provides guidance on the selection of markers in a reflection paper on markers used for quantitative and qualitative analysis.

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08.12.21

Dissolution Testing in Pharmaceutical Analysis (Part 2)

The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. There are many requirements laid down in dissolution guidances and associated documents. To get an overview, take a look here

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