GMP News

EMA publishes ICH Q14 Guideline on Analytical Procedure Development - Step 5

On 26 January 2024, the European Medicines Agency (EMA) has published the ICH Q14 Guideline on analytical procedure development - Step 5. The date for coming into effect is 14 June 2024.

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New FDA Warning Letter because of inadequate Quality Oversight

The FDA recently issued a Warning Letter to a pharmaceutical company in Thailand for violating CGMP regulations and expectations on Quality Oversight.

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EMA/CMDh: Nitrosamine Q&A Document revised

The EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" was updated again in January 2024 and is now available in revision 20. Like the three appendices, the Q&A document is published on the EMA website and can be viewed under "Questions and answers".

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EDQM: Overview of Reference Substances updated

The list of available reference standards is revised and published at regular intervals on the website of the EDQM. This comprises more than 3100 substances, including not only chemical reference substances but also herbal reference standards and biological reference preparations as well as reference spectra for carrying out tests and trials in accordance with Ph. Eur. methods.

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EDQM: Comments on the Nitrosamine Monograph possible

The updated text of the monograph "2.5.42. N-Nitrosamines in active substances and medicinal products" has been published on the website of the EDQM in the Pharmeuropa section and can be commented on until 31 March 2024, along with several other new drafts.

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Two FDA Warning Letters: Identity Testing of Incoming Components

The U.S. Food and Drug Administration (FDA) has published two new Warning Letters to companies registered as a manufacturer of over-the-counter (OTC) drug products in the United States. In both cases, the firms did not demonstrate that they adequately tested each shipment of each lot of the incoming components at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination.

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Cleanroom Pressure Control: Where should the 0 Reference be measured?

The protection concept in pharmaceutical cleanrooms is realised by the different cleanroom classes, zones and their separation by pressure levels. A frequently asked question here is: where and how should the reference, i.e. the 0 value, be measured?

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EMA publishes new questions and answers on Annex 1

At the beginning of 2024, the EMA added 4 new questions and answers to its catalogue of frequently asked questions from the GMP and GDP area.

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FDA seeks Participants for the next Phase of the Quality Manufacturing Maturity Programme

The FDA wants to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements!

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FDA Office of Compliance - Annual Report FY 2023 Published

The FDA Office of Compliance Annual Report Fiscal Year 2023 provides a detailed overview of various initiatives, primarily focused on inspections, quality, and Good Manufacturing Practice (GMP) compliance. Read more in our GMP News article.

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"Bracketing" during Process Validation

"Bracketing" in process validation has become common practice. In the USA, bracketing has been practiced for some time, and the topic was included in the Annex 15 revision in 2015 (Chapter 5.4.). However, the bracketing concept must be well justified. This is shown by a recent Warning Letter issued by the US FDA.

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New Ph. Eur. Chapter Comparability of Alternative Analytical Procedures

Following the draft chapter published in 2022, the new Ph. Eur. general chapter Comparability of alternative analytical procedures (5.27) has now been published in Supplement 11.5.

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Use of Digital Health Technologies (DHTs) to Acquire Data Remotely

Following the draft guideline published in March 2022 the FDA issued the final guidance that provides industry, investigators and others with recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical trials.

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FDA Exception from the Requirement to obtain Informed Consent

The FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of trial participants. The rule provides an exception from the requirement to obtain informed consent when a clinical trial poses no more than minimal risk to the participants.

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EMA recommends Suspension of Medicines following GCP Inspection of a CRO in India

Following a good clinical practice (GCP) inspection which showed irregularities in study data, the EMA has recommended the suspension of marketing authorizations of a number of generic medicines tested by a contract research organisation (CRO) located in India.

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Revision of USP Chapter <1053> Capillary Electrophoresis Published for Comments

In the Pharmacopeial Forum, PF 50(1), a new version of USP Chapter <1053> Capillary Electrophoresis was published. Comments can be submitted until 31 March 2024.

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GDP Non-Compliance Report for Austrian API Distributor

The Austrian Agency for Health and Food Safety has entered a new GDP Non-Compliance Report into the EudraGMDP database. This affects an active substance (API) distributor.

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Falsified Medicines in the Legal Supply Chain

Falsified medicines do not meet the standards of safety, efficacy and quality as are required and may pose a serious risk to public and animal health. That is why the topic is explicitly addressed in the EU GDP guidelines. Despite all precautions, several examples have recently come to light in which counterfeit medicines have entered the legal supply chain. 

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Checklist for Implementation of GDP Principles - Part 3: Premises and Equipment

According to Chapter 3 of the EU GDP Guidelines, wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. In this article, you will find a checklist to verify the minimum implementation.

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The GDP Non-Compliance Reports of 2023 - 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. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports published in 2023 and the respective reasons for issuing these reports.

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FDA Warning Letter: Testing of incoming Goods

In January 2024, the U.S. FDA issued a Warning Letter to the company "Prime Lab LLC" after having inspected its site in July and August 2023. According to the WL, the firm failed to do proper incoming control tests for identity of their raw materials.

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Failure to Respond to Multiple FDA Requests leads to Warning Letter

Not responding to FDA requests for records related to drug manufacturing and product quality is not a good idea, as can be seen by a recently published Warning Letter.

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FDA Warning Letter to Turkish Manufacturer of Drugs, Cosmetics and Detergents

Even with increasing distance to the pandemic situation, manufacturers of disinfectant products still seem to be relying on less stringent controls. After a large number of Warning Letters regarding hand sanitizers with contaminated or poorly analyzed products in the Americas and Southeast Asia, a Turkish company is now affected. The company Sudesan in Istanbul received a Warning Letter from the FDA listing several deviations.

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Cloud Computing: Can an automated Deployment Chain replace an IQ?

Financial and organizational advantages 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 17: Can an automated deployment chain replace an IQ? If so, what information must the deployment chain provide?

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Now Available: Reference Standards for the new Ph. Eur. Cannabis/CBD Monographs

The new Ph. Eur. Cannabis Flower and CBD Monographs require the use of specific reference standards/substances. These reference standards/substances are now available.

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