ICH guidelines hồ sơ kỹ thuật trong đăng ký dược phẩm dùng cho người

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ICH guidelines
ICH guidelines
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ICH guidelines hồ sơ kỹ thuật trong đăng ký dược phẩm dùng cho người

Các tài liệu đính kèm:

Q1A(R2)_STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

Q1B_STABILITY TESTING – PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

Q1C_STABILITY TESTING FOR NEW DOSAGE FORMS Q1D_BRACKETING AND

MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

Q1E_EVALUATION FOR STABILITY DATA

Q1F_Explanatory Note on the Withdrawal of ICH Q1F for the ICH Website

Q2(R1)_VALIDATION OF ANALYTICAL PROCEDURES – TEXT AND METHODOLOGY

Q3A(R2)_IMPURITIES IN NEW DRUG SUBSTANCES

Q3B(R2)_IMPURITIES IN NEW DRUG PRODUCTS

Q3C(R4)_IMPURITIES – GUIDELINE FOR RESIDUAL SOLVENTS

Q4B ANNEX 1_RESIDUE ON IGNITION_SULPHATED ASH GENERAL CHAPTER

Q4B ANNEX 2_TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS GENERAL CHAPTER

Q4B ANNEX 3_TEST FOR PARTICULATE CONTAMINATION-SUB-VISIBLE PARTICLES GENERAL CHAPTER

Q4B ANNEX 4A_ MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS – MICROBIAL ENUMERATIONS TESTS GENERAL CHAPTER

Q4B ANNEX 4B_MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS – TEST FOR SPECIFIED MICRO-ORGANISMS GENERAL CHAPTER

Q4B ANNEX 4C_PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS

Q4B ANNEX 5_DISINTEGRATION TEST GENERAL CHAPTER

Q4B ANNEX 6_UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER

Q4B ANNEX 7_DISSOLUTION TEST GENERAL CHAPTER

Q4B ANNEX 8_STERILITY TEST GENERAL CHAPTER

Q4B ANNEX 9_TABLET FRIABILITY GENERAL CHAPTER

Q4B ANNEX 10_POLYACRYLAMIDE GEL ELECTROPHORESIS GENERAL CHAPTER

Q4B_EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS

Q5A(R1)_VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN

Q5B_ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUCTS

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Q5C_QUALITY OF BIOTECHNOLOGICAL PRODUCTS – STABILITY TESTING OF BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS

Q5D_DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS

Q5E_COMPARABILITY OF BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS

Q6B_SPECIFICATIONS – TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS

Q7_GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS

Q8(R2)_PHARMACEUTICAL DEVELOPMENT

Q9_QUALITY RISK MANAGEMENT Q10_PHARMACEUTICAL QUALITY SYSTEM

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40 1.12 Stability Workshop ICH Q6A C

E6_R1__Guideline

E9_Guideline

Introduction_to_ICH_Website

Q2_R1__Guideline

Q8_R2_Guideline

ICH guidelines hồ sơ kỹ thuật trong đăng ký dược phẩm dùng cho người

Xem thêm tài liệu tại website Cục Quản lý Dược Việt Nam: dav.gov.vn

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