Part II, Section P: Drug Product (Finished Product)

Section A: Quality Overall Summary (QOS)

The Quality Overall Summary (QOS) is a summary that follows the scope and the outline of the Body of Data in Module 3. The QOS should not include information, data or justification that was not already included in Module 3 or in other parts of the CTD. The QOS should include sufficient information from each section to provide the Quality reviewer with an overview of Module 3. The QOS should also emphasise critical key parameters of the product and provide, for instance, justification in cases where guidelines were not followed. The QOS should include a discussion of key issues that integrates information from sections in the Quality Module and supporting information from other Modules (e.g. qualification of impurities via toxicological studies discussed under the CTD-S module), including cross-referencing to volume and page number in other Modules. This QOS normally should not exceed 40 pages of text, excluding tables and figures.

 

Reference ICH Guidelines:

-    The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Quality – M4Q(R1)

Section B: Table of Contents

To prepare the Table of Contents based on completed Print Form (Section P – Product Information)

Section C: Body of Data

To attach the Print Form (Section P – Product Information) once all the documents are completed prior to submission

P1 : Description & Composition of Finished Product

A description of the drug product and its composition should be provided. The information provided should include, for example:

·      Description2 of the dosage form;

·      Composition, i.e., list of all components of the dosage form, and their amount on a per-unit basis (including overages, if any) the function of the components, and a reference to their quality standards (e.g., compendial monographs or manufacturer’s specifications):

·      Description of accompanying reconstitution diluent(s); and

·      Type of container and closure used for the dosage form and accompanying reconstitution diluent, if applicable.

 

2 For a drug product supplied with reconstitution diluent(s), the information on the diluent(s) should be provided in a separate part “P”, as appropriate.

 

Reference ICH Guidelines:

-    Specifications – Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products – Chemical Substances (Q6A)

P2 : Pharmaceutical Development
P2.1 : Information on Development Studies
P2.2 : Components of the Drug Product
P2.3 : Finished Products
P2.4 : Manufacturing Process Development
P2.5 : Container Closure System
P2.6 : Microbiological Attributes
P2.7 : Compatibility
P3 : Manufacturer
P3.1 : Batch Formula (information based on section B1.1)
P3.2 : Manufacturing Process & Process Control
P3.2.1 : Manufacturing Process Flowchart (if any)
P3.3 : Control of Critical Steps and Intermediates
P3.4 : Process Validation and/or Evaluation
P4 : Control of Excipients
P4.1 : Specifications of Excipients
P4.2 : Analytical Protocol (Excipients)
P4.3 : Validation of Analytical Protocol (Excipients)
P4.4 : Justification of Specifications (Excipients)
P4.5 : Excipients of Human or Animal Origin (Excipients)
P4.6 : Novel Excipients (if any)
P5.1 : Specifications of Finished Product
P5.2 : Analytical Protocol
P5.3 : Validation of Analytical Protocol
P5.4 : Batch Analysis
P5.4.1 : Certificate of Analysis (COA)
P5.5 : Characterisation of Impurities
P5.6 : Justification of Specification
P6 : Reference Standards or Materials
P7 : Container Closure System
P8 : Stability Data
P9 : Product Interchangeability / Equivalence Evidence (If any)

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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