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GMP: New Q&A Document of the CMDh gives Answers to Essential Questions on the ASMF Procedure

31.10.2013
The Co-ordination Group of Mutual Recognition and Decentralised Procedures (CMDh) has published a Questions & Answers document regarding the Active Substance Master File (ASMF) procedure. In this ...

GMP: New USP Draft on Plastic Materials

31.10.2013
The current revision of General Chapter \"Plastic Materials of Construction\" should demonstrate when materials are considered as well-characterised. ...

EMA: Draft reflection paper on the risk of antimicrobial resistance transfer from companion animals

24.10.2013
Antimicrobials are important tools for the therapy of infectious bacterial diseases in companion animals. Loss of efficacy of available antimicrobial substances can seriously compromise animal ...

EMA: Draft reflection paper on injection-site residues: considerations for risk assessment and residue surveillance (revision 1)

24.10.2013
Residues in injection-site muscle for some products tend to be dramatically higher than residues in non-injection-site muscle (as well as in fat, liver and kidney). The result is that a single ...

EMA: Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle

24.10.2013
This revised guideline is intended to provide guidance on the conduct of efficacy studies and their evaluation for veterinary medicinal products that are administered via the teat canal to cattle. ...

EMA: Concept paper on the revision of the note for guidance on the approach towards harmonisation of withdrawal periods

24.10.2013
The Committee for Medicinal Products for Veterinary Use (CVMP) note for guidance: approach towards harmonisation of withdrawal periods was published in 1996. While the approach recommended for ...

FDA: Draft guideline: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

17.10.2013
The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors associated with their products. This guidance focuses on safety aspects of ...

GMP: The ECA and the PQG publish two draft chapters on GDP interpretation

17.10.2013
The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) announce the availability of two draft chapters on the interpretation of the new EU GDP Guideline. ...

FDA: Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 14 Bacterial Endotoxins Test General Chapter

17.10.2013
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their ...

GMP: Cleaning Validation Requirements in Asia

10.10.2013
The cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and APIs manufacturers. On Singapore\'s Health Authority site you can find a ...

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