Séries - WHO Expert Committee on Specifications for Pharmaceutical Preparations

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Collaborative Procedure Between the World Health Organization (WHO) Prequalification Team and National Regulatory Authorities in the Assessment and Accelerated National Registration of WHO-prequalified Pharmaceutical Products and Vaccines. WHO Technical Report Series, No. 996, 2016, Annex 8

An:

2016;

Pages:

42;


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FIP–WHO Technical Guidelines: Points to Consider in the Provision by Health-care Professionals of Children-specific Preparations That Are Not Available as Authorized Products. WHO Technical Report Series, No. 996, 2016, Annex 2

An:

2016;

Pages:

24;


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Guidance on Good Manufacturing Practices: Inspection Report. (Including Appendix 1: Guidance on Good Manufacturing Practices: Inspection Report; Appendix 2: Example of a Risk Category Assessment of the Site Depending on Level of Compliance and Inspection Frequency. WHO Technical Report Series, No. 996, 2016, Annex 4

An:

2016;

Pages:

16;


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Guidelines on the Conduct of Surveys of the Quality of Medicines. WHO Technical Report Series, No. 996, 2016, Annex 7

An:

2016;

Pages:

36;


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WHO General Guidance on Variations to Multisource Pharmaceutical Products. WHO Technical Report Series, No. 996, 2016, Annex 10

An:

2016;

Pages:

12;


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WHO Good Manufacturing Practices for Biological Products. WHO Technical Report Series, No. 996, 2016, Annex 3. (Replacement of Annex 1 of WHO Technical Report Series, No. 822)

An:

2016;

Pages:

38;


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Guidance on the Selection of Comparator Pharmaceutical Products for Equivalence Assessment of Interchangeable Multisource (Generic) Products. WHO Technical Report Series, No. 992, 2015, Annex 8

An:

2015;

Pages:

6;


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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 992 - Forty-ninth Report (Geneva, 13–17 October 2014)

An:

2015;

Pages:

228;


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Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4

An:

2012;

Pages:

76;


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