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  Tất cả | GMP EU | GMP PIC/S | GMP WHO | GMP Nhật Bản |

69 chủ đề
Phụ lục 3 - GMP WHO cho dược phẩm chứa hoạt chất nguy hiểm

Phụ lục 3 - GMP WHO cho dược phẩm chứa hoạt chất nguy hiểm

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Phụ lục 1 - GMP WHO cho sinh phẩm

Phụ lục 1 - GMP WHO cho sinh phẩm

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Validation of Aseptic processes

Validation of Aseptic processes

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Technical interpretation of revised Annex 1 to PICS GMP

Technical interpretation of revised Annex 1 to PICS GMP

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Recommendation on sterility testing

Recommendation on sterility testing

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Recommendation on risk-based inspection planning

Recommendation on risk-based inspection planning

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Isolators used for aseptic processing and sterility testing

Isolators used for aseptic processing and sterility testing

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Guidlines for the preparation of medicinal products in healthcare establishments

Guidlines for the preparation of medicinal products in healthcare establishments

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Guidlines for computerised systems in regulated GXP environments

Guidlines for computerised systems in regulated GXP environments

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Guidelines to inspections of source plasma establishments and plasma warehouses

Guidelines to inspections of source plasma establishments and plasma warehouses

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Guidelines to GDP for medicinal products

Guidelines to GDP for medicinal products

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Guidelines on GDP of active substances for human use

Guidelines on GDP of active substances for human use

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Guidelines on exposure limits

Guidelines on exposure limits

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Guidelines on excipient GMP risk assessment

Guidelines on excipient GMP risk assessment

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Guide for blood establishments

Guide for blood establishments

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Guidance on parametric release

Guidance on parametric release

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Guidance on GMP inspection reliance

Guidance on GMP inspection reliance

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Guidance on classification of GMP deficiencies

Guidance on classification of GMP deficiencies

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GMP Guide Intro

GMP Guide Intro

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GMP Guide Annexes

GMP Guide Annexes

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