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News about GMP/cGMP

EC: Harmonised Standards for Medical Device Sterilisation
15.03.2024

The European Commission adopted two implementing decisions on the sterilisation of medical devices. These decisions were made in accordance with the regulations governing medical devices and in vitro diagnostics (IVDs) in the EU.

Blog-News aus Europa
08.03.2024

The European Court of Justice (ECJ) has ruled that harmonised technical standards are part of EU law and should therefore be freely accessible to EU citizens (Judgment of 05.03.2024, ref. C-588/21 P).

Cannabis GMP Wiki planned
05.03.2024

Are you involved in the production of medicinal Cannabis? Then the Cannabis GMP Wiki is of interest to you.

EMA: 14 New/Updated Acceptable Intakes for N-nitrosamines
29.02.2024

An update of the EMA's Appendix 1 to the questions and answers for marketing authorisation holders/applicants on nitrosamine impurities in human medicinal products has just been published (EMA/72902/2024 /Rev. 3).

German Bundestag Passes Cannabis Law
26.02.2024

On 23 February, the German Bundestag approved the government's bill on the "controlled use of cannabis". The law allows adults to possess up to 50 grams of cannabis in private and up to 25 grams in public.

ICH: ICH Q12 Module 8 Training Material is Available
22.02.2024

The ICH Q12 Implementation Working Group (IWG) "Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management" Module 8 Training Material is now accessible on the ICH website.

ICH: Revision 9 of ICH Q3C Guideline Finalised
22.02.2024

The ICH Q3C “Guideline for Residual Solvents” has undergone revision to become finalised as version R9 using the Minor Revision Procedure. This revised document was published on 24 January 2024 and reached Step 4 of the ICH Process, which is the adoption of a harmonised guideline.

Blog-News aus Europa
19.02.2024

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the top 10 deficiencies identified in 2023 following the initial evaluation of new applications for Certificates of Suitability (CEP).

MHRA: Designation of Two New UK Approved Bodies
09.02.2024

On 31 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the designation of two new UK Approved Bodies (UKAB) to increase the capacity to certify the performance and safety of medical devices.

WHO: New Edition of the GMP Compendium for Medical Products
09.02.2024

The World Health Organization (WHO) has published the 10th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volume 2, Good manufacturing practices (GMP) and inspection".

FDA: Medical Devices – Quality System Regulation Amendments
07.02.2024

The US Food and Drug Administration (FDA) has released its Quality Management System Regulation (QMSR) final rule after years of development. It is a rework of the Quality System Regulation (QSR) – 21 CFR Part 820.

Swissmedic: Risk Assessment for Nitrosamine Drug Substance-Related Impurities (NDSRI)
02.02.2024

Swissmedic has further specified risk assessment measures for Nitrosamine Drug Substance-Related Impurities (NDSRI). Initially identified in 2018, nitrosamine impurities, including those in antihypertensives, prompted ongoing evaluations and measures by Swissmedic to prevent such impurities.

India: Health Ministry Revised Schedule M for GMP
26.01.2024

The Indian Health Ministry has introduced revised rules under Schedule M of the Drugs and Cosmetics Rules, aimed at ensuring robust quality control for pharmaceutical and biopharmaceutical products. Schedule M outlines Good Manufacturing Practices (GMP) for pharmaceutical products.

Blog-News aus Europa
26.01.2024

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has elaborated a document describing the principles for the declassification of documents pertaining to the CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) procedure while ensuring when necessary, the confidentiality of information.

Swissmedic: Invalid Certification of the Notified Body ECM
22.01.2024

On 9 January 2024, the Swiss Medicines Agency Swissmedic informed about critical deficits in the system of medical device regulation. 

EMA: 3 new Q&As on EU GMP Annex 1
19.01.2024

The EMA has published 3 new or updated questions and answers on Annex 1 of the EU GMP Guide. They deal with bioburden levels and sampling, and open versus closed isolators. The answers are summarised below:

EMA: 7 Q&As on In-use Shelf Life of Sterile Products After Opening/Reconstitution
19.01.2024

The European Medicines Agency (EMA) has added 7 Q&As to their quality of medicines questions and answers. They refer to EMA‘s 1998 guidance on the shelf-life of sterile products for human use after opening or reconstitution (CPMP/QWP/159/96 corr).

EMA: Q&A on Brexit Rules for Centrally Authorized Medicinal Products in Northern Ireland
12.01.2024

The European Medicines Agency (EMA) has answered nine questions on the application of revised Brexit rules to centrally authorised medicinal products for human use in Northern Ireland (Regulation (EU) 2023/1182).

EDQM: Ph. Eur. Reference Standards for Cannabis Flowers now Available
08.01.2024

The EDQM informs that the standards cannabis flower for system suitability HRS (Herbal Reference Standard) and cannabidiol for cannabis CRS (Chemical Reference Substance) that are described in the newly adopted monograph on Cannabis flower (3028) are now available for users under catalogue code Y0002440 and Y0002422 respectively.

MHRA: Alignment With EU on Extention of GMP and GDP Certificates
17.12.2023

On 11 December, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) announced a validity extension of GMP and GDP certificates.

EMA: Validity of GMP and GDP Certificates in 2024
15.12.2023

On 7 December 2023, the European Medicines Agency (EMA) published an important update on the validity of GMP certificates after COVID-19 on its Good Manufacturing Practice website:

The validity of GMP and GDP certificates, which were automatically extended to the end of 2023 under COVID-19, will be extended until 2024. Either the validity date until 2024 or the conclusion of the next on-site inspection applies, whichever comes first unless stated otherwise in the relevant document. The working group of GMP/GDP inspectors decided to continue the extension.

Blog-News aus Europa
15.12.2023

On 5 December 2023, the European Commission (EC) announced that it has adopted an implementing act to designate five EU reference laboratories (EURLs) for class D in vitro diagnostic medical devices (IVDs).

Blog-News aus Europa
12.12.2023

The EDQM pre-published the revised monograph on Propylene glycol (0430) adopted by the European Pharmacopoeia Commission (EPC) at its 177th session held on 21 and 22 November 2023. The revision took part as a response to the public health risk posed by the discovery of ethylene glycol (EG) and diethylene glycol (DEG) contamination in several medicinal products in Africa and Asia and confirmed cases of propylene glycol adulterated with EG with over 190 fatalities in Indonesia.

EMA: Q&A on Use of X-Ray Sterilisation
08.12.2023

On 9 November 2023, the EMA published a 5-page document with three Q&As on the extended interpretation of Annex 12 of the EU GMP Guideline "Manufacture of medicinal products using ionising radiation" for X-ray sterilisation processes. The questions relate to the use of X-ray sterilisation for single-use systems (SUS) in pharmaceutical manufacturing. These processes are becoming increasingly established.

Blog-News aus Europa
04.12.2023

From 6 to 7 November 2023, the PIC/S Committee Meeting took place in Bangkok, Thailand, chaired by Paul Gustafson from Health Canada. The Ministry of Public Health of the Thai Food and Drug Administration (Thai FDA) hosted the meeting.

The meeting was attended by 37 of the 56 Participating Authorities (PAs) as well as various applicants, pre-applicants and partner organisations.

Swissmedic: Technical Interpretation on Annex 1 Published
24.11.2023

On 31 October 2023, Swissmedic published a Q&A with the title "Interpretation of GMP Annex 1 2022 (Rev. 1)". In the 25-page document, the Swiss Agency for Therapeutic Products provides key answers to questions related to Annex 1, which came into force in August 2023, and to repeatedly asked questions from the previous version.

ICH: Q5A(R2) Guideline on Viral Safety of Biotechnology Products adopted
17.11.2023

The Assembly of the International Council for Harmonisation (ICH) has adopted the revised Q5A(R2) Guideline on the Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The guideline describes a general approach to testing and assessing the viral safety of those products and sets out the data that should be submitted in marketing authorisation applications and registration packages. These products include biotherapeutics and biological products derived from characterised cell cultures of human or animal origin (mammals, birds, insects). The term "virus" used therein does not include non-conventionally transmissible pathogens, such as mammalian prion-associated pathogens.

EMA: Update of Q&A on Nitrosamine Impurities
17.11.2023

After only ten days, the European Medicines Agency (EMA) published yet another revised version of the Q&A on nitrosamine impurities for marketing authorisation holders on 12 October 2023. With revision 19, Annexes 2 and 3, among others, were removed from the document and are now available as separate Appendices.

Blog-News aus Europa
17.11.2023

On 7 November 2023, MedTech Europe published a position paper on the Medical Devices Regulation (MDR (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR (EU) 2017/746). In the report, the association presents its vision for a regulated legal framework and outlines possible solutions to the ongoing challenges, which have not been overcome after the implementation phase of the MDR and IVDR.

WHO: Recognition for Swissmedic and two other authorities
14.11.2023

On 30 October 2023, the World Health Organization (WHO) recognized regulatory authorities as "WHO-Listed Authorities" for the first time. WHO-Listed Authorities (WLA) are regulatory authorities that operate in accordance with international standards and fulfil the requirements based on an established benchmarking and performance evaluation process.

ICH: Parallel Guidances Q2(R2)/Q14 on Analytical Procedures adopted
10.11.2023

The Assembly of the International Council for Harmonisation (ICH) adopted the revised Q2(R2) Guideline on the Validation of Analytical Procedures and the new Q14 Guideline on Analytical Procedure Development. They jointly describe the development and validation activities that should be applied during the life cycle of an analytical procedure to assess the quality of medicinal substances and products.

Operation Pangea XVI: Global Illicit Medicines Targeted by INTERPOL Operation
03.11.2023

Every year since 2008, the International Criminal Police Organisation (INTERPOL) has carried out large-scale operations to combat the illegal trade in medicines, known as Operation Pangea.

MHRA: Regulatory ‘Sandbox’ for AI Developers
03.11.2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it is planning to establish a new AI-based "regulatory sandbox" to help artificial intelligence (AI) developers test and provide evidence for their technologies in a virtual space under regulatory monitoring. The so-called AI-Airlock is expected to go into operation in April 2024.

Blog-News aus Europa
27.10.2023

On 24 October 2023, the European Commission adopted steps to prevent drug shortages and increase the security of supply in the European Union.

Submit IVDR Applications for Class D Devices Before the End of 2023
27.10.2023

Team-NB, the European association of Notified Bodies, strongly recommends that medical device manufacturers of Class D devices submit applications for In Vitro Diagnostic Regulation (IVDR) certification this year to ensure timely processing.

ICH: Training materials for the Q9(R1) Guideline
23.10.2023

In October 2023, the International Council for Harmonisation (ICH) published training materials to complement the revised Q9(R1) guideline on quality risk management.

EDQM: Ph. Eur. Pre-Publishes Cannabis Flower Monograph
20.10.2023

The new monograph on Cannabis flower (3028) will be published in Ph. Eur. Supplement 11.5 in January 2024. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information.

New cleanroom standard for particle sampling
13.10.2023

A new part of the ISO 14644 cleanroom series has been published: ISO/TR 14644-21:2023 Cleanrooms and associated controlled environments — Part 21: Airborne particle sampling techniques.

EMA: Q&A on Nitrosamines Updated to Rev. 18
06.10.2023

The EMA Q&A on nitrosamine impurities has been updated on 2 October 2023 and is now available as Revision 18. The update concerns Q&A 3 regarding the “call of review” and how to report steps 1 and 2 to the competent authorities. The update highlights the responsibilities of MAH(s) to control, report, and mitigate the detection of Nitrosamine impurities throughout the product life cycle, using the established procedure.

Swissmedic: FAQ on Pharmacovigilance Updated
06.10.2023

On 25 September 2023, Swissmedic expanded a list of frequently asked questions for marketing authorisation holders submitting adverse drug reaction (ADR) reports under the authority's pharmacovigilance program. The Swiss surveillance authority is thereby preparing manufacturers in its area of application for the additional documentation requirements in individual case reports, which will be mandatory from 1 January 2024.

Blog-News aus Europa
22.09.2023

MedTech Europe, along with 34 national associations, published an open letter to EU Health Commissioner Stella Kyriakides on 14 September 2023.

EMA: Q&A on Biological Medicinal Products
22.09.2023

The EMA has published 14 questions and answers for biological products on its website. The CHMP Biologics Working Party developed the page that provides their agreed positions on issues that typically arise from discussions or correspondence during assessment procedures of biological human medicinal products.

WHO: Draft on Good Practices for Pharmaceutical Quality Control Laboratories
15.09.2023

The WHO has recently published a draft document that will be of interest to all GMP practitioners in the field of pharmaceutical quality control laboratories: WHO good practices for pharmaceutical quality control laboratories. It provides recommendations for a Quality Management System (QMS) within which analyses of pharmaceutical products should be performed by quality control laboratories. The aim is to ensure accurate and reliable analytical results.

Swissmedic: Swiss GMDP database in early 2024
15.09.2023

According to Swissmedic, the independent SwissGMDP database will be launched in the first quarter of 2024. The database will be maintained similar to the European EudraGMDP database of the EMA. The GMP or GDP certificates of every company in Switzerland that has a valid Swissmedic operating licence will be listed. Contrary to the EudraGMDP, the SwissGMDP certificates contain all approved activities, i.e. the GDP activities and Switzerland-specific GMP activities of the Swiss companies will also be listed in the certificates.

Swissmedic: GMP/GDP inspections accreditation for ATMPs
28.08.2023

On 9 August 2023, Swissmedic announced its accreditation for GMP/GDP inspections in the field of ATMPs (Advanced Therapy Medicinal Products). Previously, the authority's competence confirmation was limited to medicinal products.

EMA: Q&A on Nitrosamines Updated to Rev. 17
25.08.2023

To a new one! The EMA Q&A on nitrosamine impurities has been updated again after only three weeks and is now available as Revision 17 corr. The update concerns Q&As 20, 21 and 22 and a correction of the table including the potency score calculation in example 4 for N-nitroso-l-nebivolol. It had been omitted in the previously revised version 17 and has now been re-introduced.

MHRA: Independent Regulation of CE Marking of Medical Devices
25.08.2023

On 1 August 2023, the UK government published a statement on the indefinite extension of CE marking recognition beyond 2024. MHRA clarifies: This extension does not apply to medical devices and in vitro diagnostic medical devices.

FDA: Guidance on Substance-related Nitrosamine Risks
24.08.2023

This month the US FDA issued a 28-page new guidance for immediate implementation, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). It provides drug manufacturers and applicants with a framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA. Ways to predict the mutagenic and carcinogenic risk of NDSRIs and acceptable intake (AI) limits are outlined.

PIC/S: Revision of GMP Guide includes new EU Annex 1
18.08.2023

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has again revised its GMP Guide. Changes have been made to include the new EU Annex 1 on Sterile Manufacturing of Medicinal Products, which enters into force on Friday, 25 August 2023. From this same date, the PIC/S GMP Guide will also be valid.

MHRA: Guidance on Labelling/Packaging of Medicinal Products
04.08.2023

The UK MHRA has released guidance on the labelling and packaging of medicinal products following the Windsor Framework. It introduces a “UK Only” label and the take over of the MHRA to approve and license medicines across the UK. Furthermore, the application of the EU Falsified Medicines Directive (FMD) in Northern Ireland will no longer apply. The Windsor Framework covers the supply of medicines into Northern Ireland and will replace the current Brexit conditions.

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