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 Finished Product. The QOS should not include information, data or justification that was not already included in the Body of Data. The QOS should include sufficient information from each section to provide the Quality reviewer with an overview of the Finished Product. The QOS should also emphasize 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 part and supporting information from other parts, including cross-referencing to volume and page number in other Parts This QOS normally should not exceed 40 pages of text, excluding tables and figures.

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
  • Description
  • Dosage form and characteristic
  • Describe accompanying reconstitution diluents (if any)
  • Type of container and closure used for dosage form and reconstitution diluents (if applicable)
  • Composition
  • Name, quantity stated in metric weight or measures (overages, if any), function and quality standard reference  (pharmacopoeia/manufacturer’s) of all materials used
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
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 : Control of Finished Products
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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  • Last Modified: Rabu 13 November 2019, 15:37:47.
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