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S.No. Category Code Title
1 ICH Guidelines-Quality Q4B ANNEX 9(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON TABLET FRIABILITY GENERAL CHAPTER
2 ICH Guidelines-Quality 4B ANNEX 8(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON STERILITY TEST GENERAL CHAPTER
3 ICH Guidelines-Quality Q4B ANNEX 7(R2) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON DISSOLUTION TEST GENERAL CHAPTER
4 ICH Guidelines-Quality Q4B ANNEX 6(R1) Step 2 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER
5 ICH Guidelines-Quality Q4B ANNEX 5(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON DISINTEGRATION TEST GENERAL CHAPTER
6 ICH Guidelines-Quality Q4B ANNEX 3(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON TEST FOR PARTICULATE CONTAMINATION: SUB-VISIBLE PARTICLES GENERAL CHAPTER
7 ICH Guidelines-Quality Q4B ANNEX 2(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS GENERAL CHAPTER
8 ICH Guidelines-Quality Q4B ANNEX 1(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON RESIDUE ON IGNITION/SULPHATED ASH GENERAL CHAPTER
9 ICH Guidelines-Quality Q4B ANNEX 4C(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE GENERAL CHAPTER
10 ICH Guidelines-Quality Q4B ANNEX 4B(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS GENERAL CHAPTER
11 ICH Guidelines-Quality Q4B ANNEX 4A(R1) Step 4 EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS:MICROBIAL ENUMERATIONS TESTS GENERAL CHAPTE
12 ICH Guidelines-Quality Q3C(R5) Step 4 IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS
13 ICH Guidelines-Quality Q3B(R2) Step 4 IMPURITIES IN NEW DRUG PRODUCTS
14 ICH Guidelines-Quality Q3A(R2) Step 4 IMPURITIES IN NEW DRUG SUBSTANCES
15 ICH Guidelines-Quality Q2(R1) Step 4 VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY
16 ICH Guidelines-Quality Q1F Step 4 STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN CLIMATIC ZONES III AND IV
17 ICH Guidelines-Quality Q1E Step 4 EVALUATION FOR STABILITY DATA
18 ICH Guidelines-Quality Q1A(R2) Step 4 STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
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      (From: 21-06-2012)
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