FDA Issues Technical Conformance Guide for Quality Metrics
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.
WHO: Final Version of Good Data and Record Management Practices
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.
Brexit and EMA
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.
Two Indian API Manufacturers Refuse FDA Inspection
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.
GMP MANUAL receives SIPAward
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.
Operation PANGEA IX combats illegal drug import
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.
TTIP and GMP
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.
WHO: Draft for Supplementary Guidelines on GMP for HVAC Systems
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.
MRA EU/Switzerland to be amended
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.
EMA: Process Validation for Biotechnology-derived APIs
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.
Data Integrity: Once Again the Hot Topic
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.
FDA: Draft Guideline on Data Integrity
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.
FDA: Approvement of Second Biosimilar
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.
FDA: Draft Guidance on Biosimilar Labeling
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.
IPEC Europe Publishes „HOW-TO” Guide for Risk Assessment
Meeting of EU-China Working Goup on Pharmaceuticals
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).
CDSCO India Publishes Draft to Biosimilars
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.
Importation of APIs: Version 6 of Q&A Document
WFI: Ph. Eur. adopts revised monograph on Water for Injections
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.
New Annex 1 to Appear in Autumn
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.
12-Month Transition Period for ISO 14644
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.
WFI Soon Obtainable from Reverse Osmosis (RO)
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.
Robert Califf Confirmed as New Head of U.S. FDA
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.
ICH Publishes Training Modules for Q3D Elemental Impurities
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.
Risk Assessment of Excipients: On Track?
EC: Delegated Regulation on Safety Features
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 – A New Approach
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.
CDER List for 2016 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 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.
WHO: Guidance on GMP for Biological Products
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.
PIC/S: Hong Kong SAR and Croatia new members
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.
ICH: TGA Australia latest Observer
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: Work Plan of GMP/GDP Inspectors Working Group for 2016
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.
WHO Plans a Centre of Excellence in India
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.