IMPD Headings

The table of contents for a full IMPD follows the headings as given by the relevant guidelines. The IMPD headings are based on the assumption that detailed information will be provided by the Investigational Brochure.  Only relevant information will have to be provided and several headings can in general remain empty.

2.1.S                      DRUG SUBSTANCE

2.1.S.1                   General Information

2.1.S.1.1               Nomenclature

2.1.S.1.2               Structure

2.1.S.1.3               General Properties

2.1.S.2                   Manufacture:

2.1.S.2.1               Manufacturer(s)

2.1.S.2.2               Description of Manufacturing Process and Process

2.1.S.2.3               Control of Materials

2.1.S.2.4               Controls of Critical Steps and Intermediates

2.1.S.2.5               Process validation and/or Evaluation

2.1.S.2.6               Manufacturing Process Development

2.1.S.3                   Characterisation:

2.1.S.3.1               Elucidation of Structure and Other Characteristics

2.1.S.3.2               Impurities

2.1.S.4                   Control of Drug Substance:

2.1.S.4.1               Specification

2.1.S.4.2               Analytical Procedures

2.1.S.4.3               Validation of Analytical Procedures

2.1.S.4.4               Batch Analyses

2.1.S.4.5               Justification of specification

2.1.S.5                   Reference Standards or Materials

2.1.S.6                   Container Closure System

2.1.S.7                   Stability

2.1.P                      INVESTIGATIONAL MEDICINAL PRODUCT UNDER TEST

2.1.P.1                  Description and Composition of the Medicinal Product

2.1.P.2                  Pharmaceutical Development:

2.1.P.2.1               Components of the Medicinal Product

2.1.P.2.2               Medicinal Product

2.1.P.2.3               Manufacturing Process Development

2.1.P.2.4               Container Closure System

2.1.P.2.5               Microbiological Attributes

2.1.P.2.6               Compatibility

2.1.P.3                  Manufacture:

2.1.P.3.1               Manufacturer(s)

2.1.P.3.2               Batch Formula

2.1.P.3.3               Description of Manufacturing Process and Process Controls

2.1.P.3.4               Controls of Critical Steps and Intermediates

2.1.P.3.5               Process Validation and/or Evaluation

2.1.P.4                  Control of Excipients

2.1.P.4.1               Specifications:

2.1.P.4.2               Analytical Procedures

2.1.P.4.3               Validation of Analytical Procedures

2.1.P.4.4               Justification of Specifications

2.1.P.4.5               Excipients of Human or Animal Origin

2.1.P.4.6               Novel Excipients

2.1.P.5                  Control of Medicinal Product:

2.1.P.5.1               Specification(s)

2.1.P.5.2               Analytical Procedures

2.1.P.5.3               Validation of Analytical Procedures

2.1.P.5.4               Batch Analyses

2.1.P.5.5               Characterization on impurities

2.1.P.5.6               Justification of Specification(s)

2.1.P.6                  Reference Standards or Materials:

2.1.P.7                  Container Closure System:

2.1.P.8                  Stability:

2.1.A                      APPENDICES

2.1.A.1                  Facilities and Equipment

2.1.A.2                  Adventitious Agents Safety Evaluation:

2.1.A.3                  Novel Excipients:

2.1.A.4                  Solvents for Reconstitution and Diluents: