| 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 |
