GMP News

Examples of Analytical Method Implementation

Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures, the EDQM published some examples to provide users with practical guidance. How can the critical factors potentially affecting the analytical procedure performance be identified?

More

FDA Warning Letter: Potentially Carcinogenic Contaminants in Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.

More

EDQM publishes FAQs on revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation Techniques

A revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023. Due to numerous queries received through the EDQM HelpDesk, selected questions and answers have now been published. These complement the series of existing FAQs dealing with the European Pharmacopoeia and international harmonization.

More

Revision of USP Chapter <541> Titrimetry

In the Pharmacopeial Forum, PF 48(5), a revision of USP chapter <541> Titrimetry is being proposed. Comments can be submitted until November 30, 2022.

More

USP: Third Instrument Qualification Stimuli published for Comments

As of early September 2022, the Stimuli Document "Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process" has been posted for comments on the USP Pharmacopeial Forum website.

More

EMA/CHMP: New Active Substance Guideline? Concept Paper published for Comments

Since the end of July, the "Concept paper on the revision of the guideline on the chemistry of active substances" of the CHMP's (Committee for Medicinal Products for Human Use) Quality Working Party (QWP) is available for public comments. This document aims to clarify the need to revise and update the guideline "Guideline on the chemistry of active substances (EMA/454576/2016)".

More

How to Submit Documents with Real-World Data to FDA

To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.

More

Charging for IMPs? FDA has some Answers

The FDA issued a revised Q&A document on charging for investigational medicinal products (IMPs). The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances.  

More

FDA publishes Answers to GCP Questions

The FDA addresses inquiries from stakeholders related to Good Clinical Practice on an ongoing basis and has now published responses to questions received from 2017 to 2021. One of the interesting questions asks: Is it possible to have a Remote Location ("satellite site")?

More

Labeling Requirements for IMPs Amended

The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.

More

GDP in the US: New USP Chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas

A proposal for USP chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas has been published for comments in the Pharmacopeial Forum, PF 48(5). It will apply to every link in the supply chain, such as manufacturers, wholesale distributors and third-party logistics providers. The new chapter should be viewed in the context of the United States Pharmacopeia's (USP) efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.

More

GDP Audit Check List for Air Freight Operations

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for air freight operations.

More

GDP Non-Compliance Report: No GDP conform Quality System

The competent authority of Germany (Thuringian State Authority for Consumer Protection) has entered a new GPD Non-Compliance Report dated 21 July 2022 into the EudraGMDP database. The wholesale distribution authorisation (WDA) of the company concerned was suspended. Among other things, the authority criticized the lack of a GDP-compliant quality system.

More

GDP Non-Compliance Report: No WDA without Responsible Person

On 12 July 2022, the competent authority of Germany (Regierungspräsidium Karlsruhe) added a new GDP Non-Compliance Report to the EudraGMDP database. The reason given is the fact that there is no responsible person.

More

FDA Requirements for the "Worst Case" Product during Cleaning Validation

Bracketing approaches are certainly allowed in the context of cleaning validation. First, for the products themselves, so that a "worst case" substance can be used for validation, second, for devices of the same design, the effort can be reduced by bracketing. In this way, a device can be selected. So how to define these "worst cases"? Read more here about FDA's view on this.

More

FDA Warning Letter: Lab Data Integrity disregarded

In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company "Jost Chemical Co." after having inspected its site in January 2022. The Warning Letter mentions the list of cGMP observations for Active Pharmaceutical Ingredients (APIs).

More

ANVISA´s Q&A on Medical Cannabis for Clinical Investigations

The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. One of the important questions addressed is: How can batch reproducibility be demonstrated?

More

Pharmaceutical Industry: FDA Data on the Level of Quality

The FDA has published a report on the state of drug quality - and the results are mixed. However, if one takes a closer look, the reasons can be quickly identified.

More

FDA's recommended Font and Font Size for Instructions for Use Labeling

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?

More

UK changes SUSAR Reporting for IMPs

The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.

More

USP General Chapter <621> Chromatography: Delay of the Implementation of Two New Requirements

The revised USP General Chapter <621> Chromatography is scheduled to be official on 01 December 2022. The Chemical Analysis Expert Committee has now announced that the implementation of the sections titled "Peak Sensitivity" and "Peak Symmetry" under "System Suitability" will be delayed.

More

How is Room Air Humidification of GMP Areas Performed?

Typically, the room humidity is also regulated and controlled in cleanrooms. For this purpose, the outside air is dehumidified in summer and humidified in winter, especially in dry cold weather, to ensure a minimum humidity in the cleanroom. So, how exactly is the room humidification for GMP-regulated areas carried out? What quality should the evaporated water or its condensate have? These questions are frequently asked and controversially discussed.

More

Air-Tightness of GMP Cleanrooms

There are various directives and standards that define the air-tightness of rooms and their testing in different ways. For example, for the tightness of ventilation ducts there are the tightness classes A to D according to DIN EN 15727, which have nothing to do with the EU GMP cleanroom classes A to D according to Annex 1. VDI Guideline 2083 Sheet 19 lists leakage classes from 0 to 7. So, how tight do rooms or ventilation systems actually have to be for GMP production?

More

Ph. Eur. Survey for DEHP Plasticiser Alternatives

Due to a change in REACH, the Ph. Eur. is considering to replace the plasticiser DEHP and is therefore seeking information from manufacturers. The deadline for replies is 30 September 2022.

More

EMA Publishes Comments Received on ICH Q2(R2) and Q14

In March 2022 the European Medicines Agency (EMA) published the ICH guidelines Q2(R2) on validation of analytical procedures and the ICH Q14 on analytical procedure development for public consultation. End of August, an overview of the comments received was provided.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics