EMA: Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: biological medicinal products

Product- or Population-Specific Considerations II: biological medicinal products. ...

RAPS: Proposed Rule Would Revise Regulations on Fixed-Combination Drugs

The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and ...

RAPS: FDA Warns Sun’s India Plant Over Sterility Concerns

Serious aseptic and sterility violations, including water damage and leaks in parenteral manufacturing areas, were documented by the US Food and Drug Administration (FDA) in the latest warning ...

RAPS: FDA: Explosions at Chinese Chemical Warehouse Contaminated Drugs

The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive ...

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 ...

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