GMP: Validation - Revision of Annex 15: How does the Industry see the Changes? - Results of an ECA Survey

With the publication of a draft on the revision of Annex 15 at the beginning of February 2014, changes in the area of validation/qualification were to be expected. Even then, the ECA Academy ...

GMP: Genotoxic impurities: the new ICH M7 addendum to calculation of compound-specific acceptable intakes

The final document of the ICH-Guideline M7 was published in June 2014. It describes the procedure for evaluating the genotoxic potential of impurities in medicinal products (see also our news ...

GMP: Has GMP Inspection Report of Slovenian GMP Inspectors caused FDA and Health Canada Import Alerts?

In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. The Inspectors found 17 GMP deviations of which 5 ...

GMP: FDA Inspections at API Manufacturers - current Warning Letter Trends

Taking a look at the Warning Letters the FDA issued after inspections of activesubstance manufacturers in the 2015 fiscal year, which ended on 30 September 2015, it is first of all striking that ...

RAPS: FDA Finalizes Guidance on Donor Screening for Syphilis Infection

The US Food and Drug Administration (FDA) has finalized its guidance to establishments that screen human tissue and cell donors for various communicable diseases on screening for Treponema ...

RAPS: FDA Looks to Develop Regulatory Strategies for Genomic Testing

To further the president\'s Precision Medicine Initiative (PMI), the US Food and Drug Administration (FDA) is working to develop regulatory systems for diagnostics using next generation sequencing ...

EMA: Draft qualification opinion on the ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials

Proteus Digital Health Inc. intends to have its Proteus technology approved as a ‘qualified method’ for measuring adherence to medication in clinical trials by associating relevant physiologic ...

EMA: Draft concept paper on requirements for the production and control of allergen products for use in animals

Recent developments require the revision of the existing CVMP/IWP Guideline on allergen products. Since the revision of this guideline in 1994, the scientific knowledge on structures, ...

EMA: Draft qualification opinion on the paediatric ulcerative colitis activity index (PUCAI)

The paediatric ulcerative colitis activity index (PUCAI) measures disease activity in pediatric ulcerative colitis (Turner D. et al., 2007). It was developed to act as an accurate non-invasive ...

FDA: Nonclinical Evaluation of Endocrine-Related Drug Toxicity

This guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug Evaluation ...

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