Module 3 - Strategic case studies in practice

SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES

TABLE OF CONTENTS TRANSMISSION TO INTERESTED PARTIES....................................................................1 1. INTRODUCTION.........................................................................................................3 1.1 O BJECTIVE OF THE GUIDELINE ........................................................................................3 1.2 B ACKGROUND ................................................................................................................3 1.3 S COPE OF THE GUIDELINE ...............................................................................................3 2. GENERAL CONCEPTS...............................................................................................4 2.1. P ERIODIC OR SKIP TESTING .............................................................................................4 2.2. R ELEASE VS . SHELF - LIFE ACCEPTANCE CRITERIA ...........................................................4 2.3 I N - PROCESS TESTS ..........................................................................................................5 2.4. D ESIGN AND DEVELOPMENT CONSIDERATIONS ...............................................................5 2.5. L IMITED DATA AVAILABLE AT FILING .............................................................................5 2.6 P ARAMETRIC RELEASE ...................................................................................................5 2.7 A LTERNATIVE PROCEDURES ...........................................................................................6 2.8 P HARMACOPOEIAL TESTS AND ACCEPTANCE CRITERIA ..................................................6 2.9 E VOLVING TECHNOLOGIES .............................................................................................6 2.10 I MPACT OF DRUG SUBSTANCE ON DRUG PRODUCT SPECIFICATIONS .............................7 2.11 R EFERENCE STANDARD .................................................................................................7 3. GUIDELINES ...............................................................................................................7 3.1 S PECIFICATIONS : D EFINITION AND JUSTIFICATION .........................................................7 3.1.1. D EFINITION OF SPECIFICATIONS ......................................................................................7 3.1.2. J USTIFICATION OF SPECIFICATIONS .................................................................................7 3.2 U NIVERSAL TESTS / CRITERIA ..........................................................................................8 3.2.1. N EW DRUG SUBSTANCES ................................................................................................8 3.2.2. N EW DRUG PRODUCTS ....................................................................................................9 3.3 S PECIFIC TESTS / CRITERIA .................................................................................................10 3.3.1. N EW DRUG SUBSTANCES ..............................................................................................10 3.3.2. N EW DRUG PRODUCTS ..................................................................................................12 4. GLOSSARY (THE FOLLOWING DEFINITIONS ARE PRESENTED FOR THE PURPOSE OF THIS GUIDELINE) .....................................................................................19 5. REFERENCES ...............................................................................................................21 6. ATTACHMENTS: DECISION TREES #1 THROUGH #8.......................................21

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