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The regulations in the GMP area, and thus also the framework conditions for your company, are constantly changing.
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Every week we monitor more than 50 websites, including the most important authorities worldwide, international organizations and industry associations.
In addition, we gather information on international news portals on current pharmaceutical topics.

Any relevant information about new and revised regulations or new trends are then published on our news portal "News about GMP/cGMP".

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News about GMP/cGMP

20.06.2017

Counterfeit Harvoni® Entered German Supply Chain

According to a press release by the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the German Federal Institute for Drugs and Medical Devices), a counterfeit pack of Gilead Sciences’ hepatitis C drug Harvoni® has entered the legal supply chain in Germany. The “falsified medicinal product” was identified by a patient who noticed a change in colour which was orange instead of white.

13.06.2017

CFDA: 2016 Report on Drug Inspections

The China Food and Drug Administration (CFDA) released a detailed report on inspections conducted throughout the last year. A total of 431 inspections including pre-approval inspections, GMP certification inspections, GMP follow-up inspections, unannounced inspections, overseas inspections, GSP unannounced inspection and inspection observations are analysed therein.

13.06.2017

EMA: Regulatory Guidance on Brexit for the Pharmaceutical Industry

Following a Notice to MAHs (Marketing Authorisation Holders) based in the UK the European Medicines Agency EMA and the European Commission have now released a Q&A document regarding the withdrawal of the UK from the European Union. It should help the pharmaceutical industry to prepare for the upcoming changes.

06.06.2017

Swissmedic publishes Annual Report 2016

According to the Swiss Therapeutic Products Agency Swissmedic, the agency achieved its objectives last year. Regulatory approval was granted for more than 40 innovative medicinal products partially due to a fast-track procedure.

06.06.2017

FDA: Toolkit for Supply Chain Security of Medicinal Products

In collaboration with APEC (Asia Pacific Economic Cooperation), the US FDA has created a Supply Chain Security Toolkit for Medicinal Products. The intention behind this new tool is to maximize available global resources and to deliver quality trainings and best practices in order to secure the global supply chain. It covers the entire supply chain and lifecycle from raw materials to use by patients.

26.05.2017

FDA-Warning Letter for Chinese API Manufacturer

On May 11, 2017 the US FDA issued a warning letter to Jintan Qianyao Pharmaceutical Raw Material Factory in Changzhou, China, for significant deviations from cGMP for APIs. The findings can be summarized as a complete lack of written procedures, quality-related procedures or an overall quality system.

23.05.2017

FDA: Comments on Draft Biosimilar Interchangeability Guidance

In January 2017, the FDA issued the long-awaited Biosimilar Interchangeability Guidance for public consultation. In this guidance, the Agency details its expectations for demonstrating biosimilar interchangeability.

The deadline for commenting the draft guidance ended on 19 May, with a number of 45 comments being received. Comments came from big pharmaceutical manufacturers like Pfizer, Boehringer Ingelheim, Sandoz, Johnson and Johnson or Genentech or from organisations, e.g the American Society of Clinical Oncology, the Academy of Managed Care Pharmacy, the Combination Products Coalitions or the Biosimilars Forum.

16.05.2017

British MHRA Published Trends on GMP Deficiency Data

The GMDP Inspectorate of the British MHRA (Medicines & Healthcare products Regulatory Agency) has published its yearly report on inspection deficiency findings. This time the method of gathering the data has been improved, thus introducing new data trending.

05.05.2017

EMA Should Clarify Role in Collaboration on Non-EU Drugs, Officials Say

The European Medicines Agency plans to clarify its role regarding drugs manufactured in the EU solely for the export market.

EMA officials met with delegates from European and African nations to discuss the issue in a recent workshop in Malta.

02.05.2017

PIC/S reaffirms position on proposed EU ATMP GMP Guidelines

Following PIC/S strong criticism on the proposed stand-alone ATMP (Advanced Therapy Medicinal Product) GMP Guidelines of the European Commission (we reported), PIC/S has now published a second letter to the EC on its website.

21.04.2017

EMA/FDA: Report from the EMA-FDA Quality by Design pilot program

Following the introduction of ICH Q8, Q9 and Q10, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) launched a joint pilot program for the parallel assessment of applications containing Quality by Design (QbD) in 2011. To facilitate the exchange of information between the two agencies the program was laid down under US-EU Confidentiality Arrangements. Both agencies have now issued a report that addresses the outcome of the 5-year-program so far.

21.04.2017

CDER List for 2017 Guidance Documents Updated

This month the FDA has updated its yearly list of the new and revised draft guidances CDER is planning to publish in 2017.

31.03.2017

FDA: Industry Reactions on Quality Metrics

In July 2015, US FDA released a draft guidance on quality metrics. The intention behind the introduction of quality metrics was described as a measure to improve drug quality and to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system. The document aroused a storm of criticism by the pharmaceutical industry and its organisations as soon as it appeared.

28.03.2017

FDA: More Warning Letters for Lack of Data Integrity

In 2017, the US FDA has already listed the impressing number of 73 Warning Letters on its website. One topic that emerges again and again is the violation of data integrity, with rising tendency. Remarkably often, those violations are found in China and India. This time, the following pharmaceutical manufacturers are involved:

21.03.2017

EMA: Concept Paper on the Revision of Note on Quality of Water for Pharmaceutical Use

Last week the EMA (European Medicines Agency) published a concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V) which addresses the need to update and revise the guidance which originally went into effect on 1st June 2002.

14.03.2017

PIC/S: New Strategic Plan for 2017-2019

During its February Meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) unveiled a new road map for the next two years.

 

03.03.2017

US and EU: Final Mutual Recognition Agreement for GMP Inspections

Following a three-year-process, the United States (represented by the US FDA) and the European Union (represented by the European Commission) have now finally announced their agreement to mutually recognise each other's GMP inspections of pharmaceutical facilities.

 

28.02.2017

China Food and Drug Administration: What's new?

This news summarizes the latest regulatory changes for medical devices in China and the newly issued five year-plan of the CFDA (China Food and Drug Administration).

24.02.2017

Training Presentation to ICH Q11 Draft Q&A

The ICH (International Council for Harmonisation) has developed a training presentation on the ICH Q11 Q&A document Selection & Justification of Starting Materials. Therein the Expert Working Group gives answers to the following questions:

21.02.2017

EMA: New Concept Paper for Combination Products

14.02.2017

ICH: Meeting Minutes of Osaka

The ICH has now published the Meeting Minutes of the ICH Assembly meeting which was held in Osaka, Japan in November 2016. Following you will find the key points on guidance progress in the area of GMP and on new members and observers in brief:

 

31.01.2017

FDA: Warning Letter for UK Drugmaker

The US Food and Drug Administration (FDA) already issued 7 Warning Letters in 2017, one of which went to Porton Biopharma Limited in Salisbury, United Kingdom. The UK-government owned manufacturer of biopharmaceutical products was inspected from March 7 to 18, 2016 and previously on January 12 to 23, 2015. Both inspections resulted in similar violations and a Form 483.

 

24.01.2017

PIC/S GMP Guide revised

The following chapters of the PIC/S GMP Guide have been revised based on the equivalent chapters of the EU GMP Guide:

24.01.2017

FDA: Final Guidance on CGMP for Combination Products

The US Food and Drug Administration released a 59-page final guidance on the CGMP requirements for combination products. The guidance describes and explains specific provisions from 21 CFR Part 4 (final rule on CGMP for combination products) that was released in 2013. A draft version of this document was issued in January 2015.

 

17.01.2017

CDER List for 2017 Guidance Documents

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to publish in 2017. A total of 102 planned guidance documents have been set out.

 

17.01.2017

EMA: Q&A-Draft on Exposure Limits

The EMA has released a Q&A draft document with its focus on setting health-based exposure limits for risk identification and the risk-based prevention of cross-contamination. The draft covers 14 questions and answers relating to the “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”, which was published in November 2014 and has been in force since June 2015.

 

13.12.2016

FDA: Warning Letter for Spanish API Manufacturer

The US FDA (Food and Drug Administration) released a warning letter sent to Interquim S.A., Barcelona, Spain. The drug manufacturing facility was inspected in May 2016. It summarizes significant deviations from current GMP for active pharmaceutical ingredients (APIs).

 

05.12.2016

ICH Q11: Draft Q&A Document Reaches Step 2b

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) regarding the selection and justification of starting materials, reached Step 2b of the ICH process and enters the consultation period.

 

05.12.2016

Final: ICH Q3C Guideline for Residual Solvents

The ICH Q3C(R6) Guideline “Impurities: Guideline for Residual Solvents” reached Step 4 of the ICH Process in November 2016 and now enters into the implementation period (Step 5).

 

29.11.2016

FDA releases Guidance on Contract Manufacturer Quality Agreements

On 22 November, 2016, the US Food and Drug Administration (FDA) finalized its long awaited Guidance on Contract Manufacturer Quality Agreements.

 

29.11.2016

FDA: Revision 1 of Quality Metrics Guidance

On 23 November 2016, the US Food and Drug Administration (FDA) released a Revision 1 of the draft guidance to Quality Metrics which was initially published in July 2015. The revision with the new title “Submission of Quality Metrics Data” came on short notice and is open for comments and suggestions until 24 January 2017.

 

18.11.2016

ICH: Assembly Meeting in Osaka, Japan

On 5-10 November 2016, the International Council for Harmonisation (ICH) met in Osaka, Japan, for its assembly meeting and has now published a press release.

 

03.11.2016

US/EU-Negotiations on GMP Inspections

In October, the 15th round of negotiations for TTIP (Transatlantic Trade and Investment Partnership) took place in New York. The European Commission has now published a report, which covers inter alia the mutual recognition of US/EU-GMP-inspections.

 

21.10.2016

CFDA: Draft Guidance on Data Management

According to RAPS, the CFDA (Chinese Food and Drug Administration) has released a draft guidance on drug data management practices. The paper is addressed to manufacturers, developers and distributors of pharmaceutical products and aims at an accurate, timely and traceable recording of data.

 

10.10.2016

EMA: Concept Paper on GMP and Marketing Authorisation Holders

On 4 October 2016, EMA published an interesting Concept Paper on Good Manufacturing Practice and Marketing Authorisation Holders (MAH). The document aims at giving clarity and a better understanding as to what the responsibilities of MAHs actually are in their  totality, and what they mean at a practical level.

 

07.10.2016

EDQM: New Agreement with Japanese Health Authorities

The European Directorate for the Quality of Medicines and Healthcare (EDQM) announced a new agreement with Japanese authorities. The intention is to share more information on the outcome of GMP inspections of manufacturing sites of active pharmaceutical ingredients (APIs) that are of interest to both Europe and Japan.

 

04.10.2016

CDER: Report on Drug Safety Priorities

FDA’s Center for Drug Evaluation and Research (CDER) published a comprehensive Report on the Drug Safety Priorities 2015-2016: Initiatives and Innovation. It highlights the key safety priorities and details FDA’s mission for ensuring drug safety and the protection of public health.

 

18.09.2016

Importation of APIs: Version 7 of Q&A Document

The European Commission has published a revised Version 7 of its Question and Answers Document that sets out frequently asked questions on importation of active substances for medicinal products for human use. This document is continuously updated and further supplemented.

 

12.09.2016

Annex 17: Responses to the public consultation

Almost one year ago, on 15 September 2015, the European Commission published a comprehensive draft version of Annex 17: Real Time Release Testing (we reported). The seven-page document was open for public consultation until December 2015. All in all 12 responses were received which have now been published on the Commission's website.

 

09.09.2016

ICH: Additional Training Modules to ICH Q3D

As previously announced, the International Council on Harmonization (ICH) has now published the additional two training modules to ICH Q3D Elemental Impurities on its website. The modules 8 (case studies) and 9 (FAQs) are part of a comprehensive training programme prepared by the ICH Implementation Working Group (our news of March 2016).

02.09.2016

Indian CDSCO plans recruitment of 500 GMP inspectors

According to pharmabiz.com, the Indian Central Drug Standards Control Organization (CDSCO) is planning to recruit 500 more drug inspectors by the end of 2017. Up to now 147 inspectors have already been trained to enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP).

 

02.09.2016

Indian CDSCO plans recruitment of 500 GMP inspectors

According to pharmabiz.com, the Indian Central Drug Standards Control Organization (CDSCO) is planning to recruit 500 more drug inspectors by the end of 2017. Up to now 147 inspectors have already been trained to enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP).

 

26.08.2016

FDA: Updated CDER List for 2016 Guidance Documents

On 8 August 2016, the U.S. Food and Drug Administration (FDA) updated the list of new and revised draft guidances CDER is planning to publish until the end of this year.

 

26.08.2016

EMA issues Q&As on Data Integrity

EMA has added the topic of Data Integrity to its list of Q&As regarding the overall area of EU-GMP.

 

22.08.2016

EMA: Draft Q&A on WFI Production by Non-Distillation Methods

The EMA has just published a draft for a questions and answers paper on production of water for injections (WFI) by non-distillation methods. The Ph.Eur. monograph for WFI was revised to include, in addition to distillation, reverse osmosis (RO) coupled with suitable techniques, for the production of WFI.

 

02.08.2016

PIC/S Committee Meeting and Seminar 2016

From 4 to 8 July 2016, the MHRA hosted the following events in Manchester (UK): PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar.

 

26.07.2016

MHRA: Consultation Document to GxP Data Integrity

The international hot topic of data integrity continues to develop. Eighteen months after releasing its GMP data integrity guidance, the MHRA (Medicines and Healthcare Products Regulatory Agency, UK) has now published a revision thereof. The draft document entitled GxP data integrity definitions and guidance for industrycomprises 14 pages and can be seen as the next phase of MHRA guidance.

 

18.07.2016

WHO: Draft Guidance on Validation

WHO has recently issued a 21-page draft document “Guidelines on Validation” which covers the main principles of validation and qualification. The guidelines are not intended to be prescriptive in specific validation requirements but focus on the overall concept of validation. The principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs) as well as other areas. Validation of specific processes and systems, e. g. sterile product manufacture, are beyond the scope of the guideline.

 

12.07.2016

FDA: Draft Guidance on Elemental Impurities

FDA has published an 11-page draft guidance on elemental impurities that provides recommendations regarding their control in human drug products marketed in the United States. The draft document is set up in consistence with ICH Q3D, published in August 2015 by the ICH (International Council for Harmonisation). The FDA draft guidance intends to help manufacturers to comply with ICH and United Pharmacopeial Convention (USP) standards.

 

08.07.2016

ICH: Meeting News from Lisbon

The International Council for Harmonisation (ICH) met in Lisbon, Portugal in June 2016. Two new members were accepted and 14 new observers welcomed.

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