GMP News

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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FDA Publication on Elemental Impurities in Cannabis following Vaporization

Following the previously issued article on microbial contamination, authors from the FDA recently published an article on elemental impurities in cannabis following vaporization. The results indicate that a transfer of heavy metals from cannabis material to cannabis vapor may not occur during the vaporization process under the applied study conditions.

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The New Ph. Eur. Monographs Cannabis Flower and CBD are now Published

The Ph. Eur. Suppl. 11.5 is now available containing the new Ph. Eur. Cannabis Flower monograph and the new Ph. Eur. monograph Cannabidiol (CBD). The Ph. Eur. CBD monograph now clearly defines: CBD is isolated from the Cannabis sativa L. plant.

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Update of the EMA Q&A document on Combination Products

Combination products (the combination of a medicinal product and a medical device) are increasingly "on the rise". However, the regulation governing these combination products is very complex. For the EU area, the EMA Q&A document Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) provides assistance in this regard.  The document was revised at the end of 2023. What is new?

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Notified Body Survey on Certificates and Applications under the Medical Devices/IVD Regulation

The results of a survey of 39 Notified Bodies were published by the EU Commission at the end of 2023. It concerns certifications and applications under the Medical Device/IVD Regulations (MDR/IVDR). What are the results?

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MDCG Guidance on the Responsible Person according to Article 15 MDR Updated

With the implementation of the Medical Device Regulation (MDR), a "responsible person" according to Article 15 MDR also became mandatory. Minimum requirements for this "person responsible for regulatory compliance" are specified in this article.  Further information can be found in the guideline "MDCG 2019-7", which has now been revised. What are the changes?

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Ozempic Falsification also in the US

Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warned consumers not to use counterfeit Ozempic® found in the US drug supply chain.

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FDA Warning Letter: Missing Stability Studies

In December 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023. According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product.

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FDA Launches Electronic Submission Portal for Cosmetics

The FDA issued the final guidance on cosmetic product facility registrations and product listings, as mandated by the MoCRA. Amongst others, the guidance contains information about a new electronic registration and listing submission portal: Cosmetics Direct which is now available.

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