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picture1_Technology Development Pdf 86633 | Production Quality Control Medicinal Products Derived Recombinant Dna Technology En


picture2_Technology Development Pdf 86633 | Production Quality Control Medicinal Products Derived Recombinant Dna Technology En picture3_Technology Development Pdf 86633 | Production Quality Control Medicinal Products Derived Recombinant Dna Technology En

 88x       Filetype PDF       File size 0.06 MB       Source: www.ema.europa.eu


File: Technology Development Pdf 86633 | Production Quality Control Medicinal Products Derived Recombinant Dna Technology En
_______________________________3AB1a PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY Guideline Title Production and Quality Control of Medicinal Products derived by recombinant DNA Technology Legislative basis Directive ...

icon picture PDF Filetype PDF | Posted on 14 Sep 2022 | 2 years ago
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...Aba production and quality control of medicinal products derived by recombinant dna technology guideline title legislative basis directive eec as amended date first adoption adopted june this version december entry into july force status last revised previous titles other iii references additional notes note for guidance is intended to facilitate the collection submission data support applications marketing authorisation within polypeptide based rdna use in man it concerns application part sections a e annex with view granting new product contents introduction points consider development genetics cell banks fermentation or culture purification active substance consistency routine batch bulk final specification reference materials finished pharmaceutics developments molecular nucleic acid chemistry enable genes coding natural biologically proteins be identified analysed fine detail transferred between organisms expressed under controlled conditions so obtain synthesis which they code su...
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