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News about GMP/cGMP

24.02.2017

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:

14.02.2017

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

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

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

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

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

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

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

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

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

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

 

29.11.2016

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

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

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

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

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

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

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

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

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

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

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

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

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

 

22.08.2016

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

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

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 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 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

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

04.07.2016

The FDA has issued a 10-page technical specifications document providing recommendations on the submission of data to support quality metrics as part of the process validation lifecycle and pharmaceutical quality system assessment. The guide serves as the technical reference for implementation of the draft FDA guidance “Request for Quality Metrics” that was published in July 2015 and can be seen as a supplement.

 

04.07.2016

Almost one year after publishing the draft, the WHO has now issued the final version of the Guideline to “Good Data and Record Management Practices”. The document is part of the Technical Report Series No. 996, 2016 and is therein listed as Annex 5.

 

28.06.2016

With the U.K. voting to leave the EU, the speculation about a new headquarter for the European Medicines Agency EMA have started. The London-based EMA approves medicines for all EU countries. With a full-time staff of around 750, it is the largest EU body in Britain.

 

24.06.2016

According to the US FDA, two Indian manufacturing facilities have been added to the Red List of foreign firms that are now banned from shipping product to the US. Cheryl Laboratories, Mumbai, producing active pharmaceutical ingredients (APIs) and Phalanx Laboratories, Visakhapatnam, producing APIs and intermediates both refused FDA inspections without giving any comment.

 

20.06.2016

On 7 June 2016, Maas & Peither-GMP Publishing received a SIPAward in Washington, DC, USA, at the 40th SIPA Annual Conference. The GMP MANUAL was nominated out of 228 applications in the special category "Best New Success Story" and was awarded 3rd place. The GMP MANUAL is the world’s largest GMP knowledge database for the pharmaceutical industry and impressed the jury with “Save Drugs through Better GMP Understanding”. Prizes in a total of 25 categories were awarded.

14.06.2016

From May 30 to June 7, 2016, the Ninth Annual International Internet Week of Action took place. This global cooperative effort, led by INTERPOL, aims at fighting the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet. The operation involved regulatory authorities, custom agencies and law enforcement form more than 100 countries.

 

06.06.2016

In April 2016, the Transatlantic Trade and Investment Partnership „TTIP” , negotiated between the EU and the US, was taken one step further. The 13th round of negotiations took place in New York. The European Commission has now published a detailed report on the three negotiated areas market access, regulatory cooperation and rules. Furthermore the EU has released a 7-page EU-proposal for an annex on medicinal products containing details for the pharmaceutical sector.

 

27.05.2016

The WHO has revised its Technical Report Series, No. 961, 2011, Annex 5: Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms. A draft has been published for public consultation.

 

20.05.2016

The European Commission is about to adopt an amendment to the Mutual Recognition Agreement (MRA) with Switzerland. The amendment would cover the mutual recognition of GMP inspections in third countries as well as products manufactured outside Switzerland.

 

13.05.2016

The European Medicines Agency (EMA) has finalized a guidance that covers process validation including process characterization and process verification in the manufacture of biotechnology-derived active substances. This document provides guidance on the data to be included in a regulatory submission to demonstrate that the manufacturing process is in a validated state.

 

29.04.2016

Another Indian drug maker received a warning letter issued by the US FDA. Once more the hot topic is data integrity – a common feature nowadays.

18.04.2016

Data manipulation and data integrity issues are topics that constantly appear in the press. In recent years, cGMP violations involving data integrity have been increasingly observed, especially in China and India. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy and quality of drugs. Following the MHRA and the WHO, that have both released draft documents on this subject in 2015, the US Food and Drug Administration (FDA) has now published a Draft Guidance on Data Integrity and Compliance with cGMP, as well.

 

11.04.2016

The US Food and Drug Administration (FDA) approved a second biosimilar, Inflectra (infliximab-dyyb), biosimilar to Janssen Biotech’s arthritis treatment Remicade (infliximab). Inflectra, coming from Celltrion and Pfizer, is a monocional antibody biosimilar. The European Medicines Agency already approved Celltrion’s Remicade biosimilar in 2013. Other countries that already gave their approval are Canada, Japan and Korea.

11.04.2016

Following the three final guidances on quality considerations, scientific considerations and Q&As about biosimilars, the FDA has now released a 15-page draft guidance for industry on Labeling for Biosimilar Products. The guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing draft labeling for submission in proposed biosimilar product applications.

 

01.04.2016

21 March 2016 marked the date on which Manufacturing Authorisation Holders (MAHs, also known as pharmaceutical product manufacturers) needed to be compliant with the “Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use”. IPEC Europe has developed and published a 36-pages "How-to" documentto help explain how a company might perform a risk assessment to determine the appropriate GMPs necessary for each excipient they use in drug products.

01.04.2016

On 9 March 2016, a meeting of the EU-China Working Group on Pharmaceuticals was held in Beijing. A delegation of the CFDA met with Andrzej Rys, Director of DG Sante of the European Commission and Guido Rasi, Executive Director of the EMA (European Medicines Agency).

 

 

30.03.2016

The Central Drug Standard Control Organization CDSCO of India has published a new Guideline on Similar Biologic. The 58-pages document will replace the previous guidance issued in 2012. The new version is now open for discussion until April 30, 2016.

 

18.03.2016

The European Commission has published a revised Version 6 of its Question and Answers Document that sets out frequently asked questions on importation of active substances for medicinal products for human use.

 

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