News about GMP/cGMP

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both released draft documents on this subject in 2015, the US Food and Drug Administration (FDA) has now published a Draft Guidance on Data Integrity and Compliance with cGMP, as well.

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.

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on quality considerations, scientific considerations and Q&As about biosimilars, the FDA has now released a 15-page draft guidance for industry on Labeling for Biosimilar Products.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.

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.

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).

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.

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.

During its 154th Session, the Ph. Eur. Commission adopted a revision of its monograph for Water for Injections (0169). Up to now, the production of Water for Injections (WFI) had been limited to distillation only.

The revised Annex 1 on sterile and aseptic production of the EU GMP Guide is expected to appear this autumn. The draft will be discussed soon in the EMA IWG and the PIC/S. Afterwards it will proceed as an approved draft to public consultation. The document will be completely revised without being restricted to isolated improvements.

According to Andrew Hopkins, MHRA, the new ISO 14644:2015 will be given a 12-month period for implementation. This was explained during the introduction of the contents of the new Annex 1 at a conference in in Frankfurt.

The European Pharmacopoeia envisages the production of water for injections (WFI) in Europe as well with the aid of reverse osmosis. Susanne Keitel, EDQM, reported in Frankfurt that the decision is expected to be made this week.

The U.S. Food and Drug Administration (FDA) announced the confirmation of Dr. Robert Califf, M.D., as next commissioner of the FDA. He fills the position left by Dr. Margaret Hamburg, who stepped down after six years as commissioner.

The International Council on Harmonization (ICH) has published eight training modules on the ICH Q3D Guideline Elemental Impurities. These modules are part of a comprehensive training programme prepared by the ICH Implementation Working Group.

From 21 March 2016 onwards, the new requirement of the Guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use enter into force. These guidelines are part of the EU GMP-GUIDE Part III and were published in their final version a year ago. Basically, the manufacturing authorisation holder is obliged to ensure that the excipients used are safe for drug manufacturing and that an appropriate level of GMP-standards has been applied.

On 9 February 2016 the European Commission published the Delegated Regulation 2016/161 in its Official Journal. The document sets out the details of obligatory “safety features” for the packaging of medicinal products for human use.

Counterfeit drugs are a major threat to public health. Current efforts to guard against counterfeit medicines often focus on serialization of the secondary packaging which - while providing a substantial improvement in patient safety - does not allow tracing of the individual unit.

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to publish in 2016. A total of 102 planned guidance documents are set out. There are a couple of carry overs from 2015, e. g. documents on the drug supply chain security act, on biosimilars or two guidances in the field of GMP.

The WHO has listed a revised guideline WHO GMP for Biological Products which was adopted by the 66thMeeting of the WHO Expert Committee on Biological Standardization. The document is proposed to be published in its final editorial form in the next WHO Technical Report Series.

On 1 January 2016, the Pharmacy and Poisons Board of Hong Kong SAR (PPBHK) as well as the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) became the 47th and 48th PIC/S Participating Authorities.

According to the ICH, the Australian Therapeutic Goods Administration (TGA) has become the latest ICH Observer. In this position the TGA is now allowed to attend ICH Assembly meetings and to participate in ICH activities.

EMA has published the work plan of the GMP/GDP Inspectors Working Group for 2016. The plan covers the different tasks of the group, e.g. harmonisation of inspections, mutual recognition agreements (MRAs) (maintenance, extension of scope) and GMP/GDP topics.

According to pharmabiz.com the WHO expressed strong interest in setting up a centre of excellence (CoE) in regulatory science at the Indian Gujarat FDCA’s (Food and Drug Control Administration) office. This will be the first Asia-Pacific-CoE of the WHO. If things go as planned, all the financial and technical support will be given by the WHO while the state government of Gujarat will provide infrastructural support within the FDCA’s building.