GMP News

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.

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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.

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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?

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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.

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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.

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Guidance for Industry on the Topic of Cross-Contamination

The topic cross-contamination is very important in the GMP environment. For example, Chapter 5 of the EU GMP Guide was adapted in this regard a few years ago. Annex 15 also paid more attention to the topic with the 2015 revision. However, the topic is also an issue in the USA.

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FDA also does not accept creative Arguments for Lack of Validation

In the GMP rules there are many undefined terms, such as regular, adequate, etc. Inspection reports that interpret these undefined legal terms sometimes help here. In this case it is about insufficient process validation. What happened?

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USP Article: In Vitro Test Methods for Continuous Manufacturing

The continuous manufacture of medicinal products is a young, spreading type of modern pharmaceutical production. In contrast to classical batch manufacturing, these processes run continuously, i. e. dosing and product withdrawal run uninterrupted and are continuously monitored. A recent USP article discusses what release testing might look like.

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Finalised: The revised EU Annex 1 is published

After more than five years and two public drafts for comment, the European Commission this week published the final version of the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". Learn more about deadlines and changes compared to the 2nd draft version for comment from 2020.

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EU-GMP Adjustments in the next Years

The EMA has published a three-year plan. This plan of the GMDP Inspectors Working Group (IWG) also includes plans to revise the EU GMP guidelines.

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FDA Form 483: Sampling Obviously Documented Incorrectly

The U.S. Food and Drug Administration (FDA) issued a Form 483 to India-based manufacturer Sun Pharmaceutical following an inspection of its Mohali facility in August 2022. Among other observations, it came out that employees responsible for collecting samples did not enter the buildings where the samples were documented to have been collected. In other cases, based on building access records, the employee was in a different building at the time the sample was documented to have been collected.

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Medical Device Information available on EMA's Website

We have already reported about information regarding medical devices available on the EU Commission's website. Recently, a chapter on in vitro diagnostics (IVDs) was added. Also, the EMA website has a dedicated page for medical devices. What can be found there?

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FDA draws consequences for poor quality of hand disinfectants and UV Wands

In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.

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Great Britain plans a New "Mark" for Medical Products as a Replacement to the CE Mark

With UK's exit from the EU (Brexit), a transition period also started with regard to medical devices. The MHRA has now published plans on how to proceed after this transition period.

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GDP Audit Check List for Ocean Freight Operations

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

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GDP in the US: The USP <1079> Series of Chapters on Good Storage and Distribution Practices

The United States Pharmacopeia (USP) continues its efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices. But what is the current status?

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Amazon Receives Warning Letter from FDA

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.

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FDA Warning Letter: Testing, Stability Program and Quality Oversight

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an over-the-counter (OTC) drug product manufacturer in Los Angeles. Several GMP violations were identified in the area of laboratory testing, stability program, and quality oversight. In a previous inspection in 2018, similar observations were made. Therefore, the FDA considers the executive management oversight and control over the manufacture of drug products as inadequate.

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China GMP: New Annex 13 for IMPs

In May, the Chinese National Medical Products Administration (NMPA) published their new Annex 13 "GMP for Investigational Medicinal Products (IMPs)", which was incorporated into the Chinese GMP guidelines on July 01, 2022.

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Refusal to Permit Inspection - What are the Consequences?

Inspections are a regulatory requirement in the GMP environment. This also applies to the USA. But what happens if a manufacturer simply refuses to permit a GMP inspection?

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FDA publishes ICH Q9 Draft Document

Since the end of last year, the ICH Q9 document on quality risk management has been in stage 2 of the ICH process for publishing ICH documents as a draft revision 1. Now, the draft document has also been published by the FDA on its website and is available for comments.  

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China GMP and Registration of APIs - Q&As

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers team.

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Nitrosamine Impurities: Extension of the Deadline for the Submission of Variations

EMA's Question and Answer document on nitrosamine impurities is addressed to marketing authorisation holders. This document describes the approach to review the manufacturing processes for chemically-synthesised and biological medicinal products and to do the risk assessments accordingly. Read more about which new deadlines for variations have to be observed and what has changed in the forms.

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CMC: FDA publishes Guideline with questions on post-approval modification of single-use materials

With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).

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Data Integrity Problems as Main Topic of an FDA Warning Letter

Data integrity is still one of the major topics in FDA inspections. Missing controls to ensure the integrity of electronic data as well as inadequate access controls were some of the reasons why a Warning Letter to American company Vi-Jon was issued.

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