GMP News

Updated ICH E2B(R3) Q&As on ICRs

The updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. The update includes a new Q&A regarding information about vaccine reporting.

More

Dosage versus Dose

The U.S. FDA published a draft guidance on the dosage and administration labeling section for certain medicinal products. The guidance is one of several FDA guidance documents addressing labeling for human prescription drugs.

More

Format and Content of a REMS Document

The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products including a separate guide that contains a REMS Document Template.

More

ICH Q9 Quality Risk Management published as Revision 1

In December 2020, you could already read about the ICH announcement to revise the ICH Q9 Quality Risk Management Guidelines. The final version has now been published.

More

Restrictions for PTFE used in Pharmaceutical Plant Engineering?

Fluoropolymers have an extremely high chemical stability. However, this stability also means that once they enter the environment, they can remain there for a very long time and cause environmental damage. The EU plans to restrict or ban perfluorinated and polyfluorinated alkyl substances (PFAS), which include PTFE, for example, in the future. This would have serious consequences for plants in the pharmaceutical industry, for example, where PTFE is used as a material for seals.

More

Cloud Computing: Reasons for choosing the particular Cloud Model?

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 3: What are the reasons for choosing the particular cloud model (private cloud, community cloud, public cloud)?

More

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.

More

Does Heating in a Vaporizer Reduce the Microbial Load in Cannabis?

There is currently an ongoing discussion about the microbiological quality requirements for medical Cannabis depending on the route of administration. To move forward authors from the FDA recently published an article about a microbiological study of bulk Cannabis.

More

Nitrosamine Impurities: EDQM completes General Monographs 2034 and 2619

The two pharmacopoeial monographs (2034) and (2619) have recently been revised. Read more about the requirements that manufacturers of APIs need to follow with regard to possible nitrosamine contamination in their products.

More

Revision of USP Chapter <621> Chromatography Concerning Signal-to-Noise Ratio

The Chemical Analysis Expert Committee intends to revise the USP General Chapter <621> Chromatography. Changes to the subsection on the signal-to-noise ratio are planned.

More

FDA Warning Letter caused by Lab Data Integrity issues

In December 2022, the U.S. FDA issued a Warning Letter to the Brazilian company "Nortec Quimica SA" after having inspected its site in Rio de Janeiro in July 2022. Significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs) are listed and a long list of Data Integrity remedation activies is required.

More

USP: Further Updates on "Residual Solvents" published for Comments

The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.

More

Recommendations of Notified Bodies on Hybrid Audits in the Medical Device Sector

In a 3.5 pages position paper, Notified Bodies have presented their views on hybrid audits of medical device and IVD manufacturers. What does it say?

More

Update of the EMA Q&As on GDP Requirements

Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging? This is one of three new questions answered by the European Medicines Agency (EMA) on its website. The other two questions relate to the activities of brokers with parties outside the EEA.

More

What are the Requirements for Premises and Storage Facilities?

Wholesale distributors must have suitable and adequate premises and storage facilities. But what are actually the specific requirements according to the EU GDP Guidelines?

More

FDA Warning Letter due to Inadequate Storage Conditions and Repacking/Relabeling Operations

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.

More

GDP in the US: FDA warns Company for Violation of Drug Supply Chain Security Act

The U.S. Food and Drug Administration (FDA) has published a so-called untitled letter to a US company. The FDA states that the firm violated the Drug Supply Chain Security Act (DSCSA). Specifically, the letter concerns a former subsidiary of the company that was a licensed pharmacy and wholesale drug distributor.

More

The GDP Non-Compliance Reports of 2022 - An Overview

If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. We have prepared an overview of the GDP Non-Compliance Reports published in 2022 and the respective reasons for issuing these reports.

More

FDA publishes Lists of planned Medical Device Guidances 2023

In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?

More

ICH Q13: Final Version of Guideline for Continuous Manufacturing published

Already in 2018, the ICH had started working on a Guideline entitled "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS - Q13". A draft was published in mid-2021. Now ICH has approved the final version.

More

Risk Analyses do not always help - Example of Cross-Contamination

With ICH Q9 Quality Risk Management becoming effective, risk analyses have become the "magic word" in the GMP environment. But risk analyses do not always help. An example of this can be found in an FDA Warning Letter on the subject of cross-contamination.

More

ICH M10 Guideline on Bioanalytical Method Validation and Study Sample Analysis

The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.

More

Revision of USP Chapter <1236> Solubility Measurements Published for Comments

In the Pharmacopeial Forum, PF 49(1), a proposal for a revised USP General Chapter <1236> Solubility Measurements was published. Based on comments received, some revisions were made in addition to those proposed in PF 48(2).

More

Australia Amended its Cannabis Regulation regarding GMP Requirements

Australia´s Therapeutic Goods Administration (TGA), which regulates Medicinal Cannabis in Australia, has put out its latest Compilation regarding the production and import regulations (TGO 93). As of July 2023, all imported medicinal cannabis products released for supply in Australia will have to present evidence to be produced under GMP.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics