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Italian Inspectors Find Non-Compliance in Italian and Chinese Plants

The Eudra GMP database indicates that the Italian Medicines Agency issued a statement of non-compliance regarding the I.C.I International Chemical finished pharmaceuticals Cellole, Italy plant in late September. The plant was cited for unauthorized “shadow” production and a lack of product traceability. Equipment maintenance and hygienic practices were also of concern. In late October, the […]

EMA Advises Submission of Type I Variations by December

EMA has advised that companies submitting Type IA variations do so by November 28. The agency states that this will allow them to determine the validity of the submission before the agency’s closure on December 24.

EMA Updates Pre-authorisation Advice

EMA updated their advice document for “pre-authorisation” procedures in October. Changes were made to section 18, dealing with fee waivers and reductions, and section 47, dealing with environmental risk assessment.

Final EMA Guideline Update on Biosimilars

In late October, EMA released a final update to its 2005 Similar Biological Medicinal Products guideline. A draft update was released in May 2013 to clarify how biosimilarity is defined regarding safety, efficacy, quality, and biological activity. Changes from the draft to the final include clarification on the need for similarity to the reference product […]

ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments

The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process....

Guideline on Regulatory Acceptance of 3R testing

EMA issued a draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) for use in animal testing approaches. The guideline describes the submission and evaluation process for 3R testing for drug development and production related to non-clinical/safety testing and batch control.

EDQM Hosted Events International Meeting of World Pharmacopeias

In early October EDQM hosted the 4th WHO International Meeting of World Pharmacopoeias at its Strasbourg France headquarters. The meeting focused on harmonization and strengthening WHO’s role in developing global standards for the production and testing of medicines. That same week EDQM hosted its 50th anniversary meeting that included workshops on QbD, impurities, certification, and […]

Monthly Update, August-September 2014

In focus are: ● a significant proposal from prominent industry experts on revising the CMC submission paradigm to help spur transparency, QbD and continuous improvement, along with FDA reviewer comments on the proposal ● a series of new FDA guidances and an EU initiative on the generic drug review process ● Amgen’s MS-based “multi-attribute methodology” initiative to streamline biotech development and QC, and ● the Rx-360 keys to a strong supply oversight program and how Amgen is applying them....

New Ph. Eur. Policy on Bacterial Endotoxin Testing

In September, Ph. Eur. released a new policy on testing for bacterial endotoxins. The policy now recommends that new monographs include testing without a limit when a specific method has been described – leaving it up to the manufacturer to determine the appropriate limit. Existing monograph test limits will remain the same.

EMA Starting Material Requirements

In September, EMA released a reflection paper on the selection and justification of starting materials. The paper clarifies issues that have arisen in the wake of the implementation of ICH’s API development and manufacturing guideline Q11.
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