GMP News - Analytical Quality Control

22.03.23

New JP Ultraviolet-Visible and Infrared Reference Spectra Published

In March 2023, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published the "JP Drafts (March 2023) No.2 ". In this context, five new Ultraviolet-visible and Infrared reference spectra were published.

22.03.23

Four JP Drafts Related to Balances Published for Public Comments

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Balances. Comments can be submitted until 31 March 2023.

15.03.23

USP: New General Chapter Supplier Qualification <1083>

On August 01, 2023, the new USP Chapter "<1083> Supplier Qualification" will officially enter into force. In the USP Forum, the draft chapter could be viewed and commented on until the end of November 2021.

15.03.23

Another FDA Warning Letter to US Manufacturer of Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has once again published a Warning Letter to a US manufacturer of hand sanitizers. During an inspection, several CGMP violations were found. In addition to inadequate release testing in general, the finished products are likely to be contaminated with methanol.

08.03.23

EDQM: Supplement 11.2 of the European Pharmacopoeia available

Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.

08.03.23

FDA Warning Letter to Turkish OTC Manufacturer

The U.S. Food and Drug Administration (FDA) sent a Warning Letter to a drug manufacturer in Istanbul. During an inspection, several CGMP violations were found. Among other things, this concerns identity testing of incoming components, process validation and stability testing.

01.03.23

EDQM: Updated List of Reference Substances

On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at regular intervals. It indicates which reference substances have been replaced by new batches and which standards have been removed from the list of reference substances (since January 2023) or will be deleted in the future (as of April or July 2023).

22.02.23

The Series of Warning Letters to Manufacturers of Hand Sanitizers does not stop

Even after many pandemic measures have expired, and although shortages in hand sanitizer supply are no longer of such high concern, the aftermath still seems to linger in the form of poor quality management in manufacturing, according to a new warning letter from the FDA.

15.02.23

Comments on FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence published

In December 2022, the U.S. Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence". Comments and suggestions could be submitted until 04 February. After this deadline, the comments received have now been published.

15.02.23

USP is Announcing a Proposal to Modify the Glass General Chapter <660>

Due to the current shortages of glass vials the USP is announcing a proposal to modify General Chapter <660> Container— Glass. In particular, the revision is anticipated to remove the glass classifications based on composition.

15.02.23

Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology Procedures

The European Directorate for the Quality of Medicines & HealthCare (EDQM) issued a press release indicating that public consultation on two Ph. Eur. chapters on pharmaceutical technology procedures has been started. These are the revised general chapter 2.9.3 "Dissolution of tablets and capsules" and the new general chapter 2.9.55 "Characterisation of powder behaviour during compression".

15.02.23

The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

08.02.23

FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has published two Warning Letters to manufactures of hand sanitizer drug products. In both cases, acetaldehyde and acetal impurities at unacceptable levels were found in several lots. The agency is concerned, because acetaldehyde is considered to be genotoxic, and potentially carcinogenic.

08.02.23

USP Proposes to Add Flexibility in the Selection of Parenteral Packaging

To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass.

01.02.23

Revision of USP General Chapter <661.1> Plastic Materials of Construction

The USP revised the general chapter <661.1> Plastic Materials of Construction. In particular the sections on Polycarbonate and PVC have been updated.

Page 1 of 32

1
2
3
4
5
6
7
Next
Last »

Recommended Event

Munich, Germany

10-12 October 2023

GMP SEARCH ENGINE

GMP News - Analytical Quality Control

New JP Ultraviolet-Visible and Infrared Reference Spectra Published

Four JP Drafts Related to Balances Published for Public Comments

USP: New General Chapter Supplier Qualification <1083>

Another FDA Warning Letter to US Manufacturer of Hand Sanitizers

EDQM: Supplement 11.2 of the European Pharmacopoeia available

FDA Warning Letter to Turkish OTC Manufacturer

EDQM: Updated List of Reference Substances

The Series of Warning Letters to Manufacturers of Hand Sanitizers does not stop

Comments on FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence published

USP is Announcing a Proposal to Modify the Glass General Chapter <660>

Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology Procedures

The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers

USP Proposes to Add Flexibility in the Selection of Parenteral Packaging

Revision of USP General Chapter <661.1> Plastic Materials of Construction

Recommended Event

Product Transfer Organisation of a GMP-compliant Site Change

GMP News - Analytical Quality Control

New JP Ultraviolet-Visible and Infrared Reference Spectra Published

Four JP Drafts Related to Balances Published for Public Comments

USP: New General Chapter Supplier Qualification <1083>

Another FDA Warning Letter to US Manufacturer of Hand Sanitizers

EDQM: Supplement 11.2 of the European Pharmacopoeia available

FDA Warning Letter to Turkish OTC Manufacturer

EDQM: Updated List of Reference Substances

The Series of Warning Letters to Manufacturers of Hand Sanitizers does not stop

Comments on FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence published

USP is Announcing a Proposal to Modify the Glass General Chapter <660>

Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology Procedures

The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers

USP Proposes to Add Flexibility in the Selection of Parenteral Packaging

Revision of USP General Chapter <661.1> Plastic Materials of Construction

Recommended Event

Product Transfer Organisation of a GMP-compliant Site Change

GMP Newsletter

GMP Conferences by Topics