cGMP and Regulatory Updates

PREAMBLE This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. This guideline merely demonstrates an appropriate write-up format for acquired data. However, applicants can modify, if needed, to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration. Throughout the ACTD, the display of information should be ...

1 INTRODUCTION To exert an optimal therapeutic action an active moiety should be delivered to its site of action in an effective concentration for the desired period. To allow reliable prediction of the therapeutic effect the performance of the dosage form containing the active substance should be well characterised. In the past, several therapeutic misadventures related to differences in bioavailability (e.g. digoxin, phenytoin, primidone) testify to the necessity of testing the performance of dosage forms in delivering the active substance to the systemic circulation and thereby to the site of action. Thus the bioavailability of an active substance from a pharmaceutical product should be known and reproducible. This is especially the case if one product containing one certain active substance is to be used instead of its innovator product. In that case the product should show the same therapeutic effect in the clinical situation. It is generally cumbersome to assess this by clinical ...

VALIDATION OF ANALYTICAL PROCEDURES 1. Introduction The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. This guideline is to provide the guidance and recommendation of validation of the analytical procedures for submission as part of registration applications within ASEAN. The document mainly adopts two ICH guidelines “Q2A: Validation of Analytical Methods: Definitions and Terminology, 27 October 1994” and “ICH Q2B: Validation of Analytical Procedure: Methodology, 6 November 1996. The methodology applied for biological and biotechnological products may be approached differently than chemical entities. All relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate. Well-characterized reference materials, with document purity, should be used throughout the validation study. The degree of purity depends on the intended use. In prac...