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

Section A: Quality Overall Summary (QOS)

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

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:

  • Descriptionof the dosage form;
  • A batch formula should be provided that includes a list of all components of the product to be used in the manufacturing process, the amounts per unit dose, including overages (if any), and a reference to their quality standards.
  • Description of accompanying reconstitution diluent(s); and
  • Type of container and closure used for the dosage form and accompanying reconstitution diluent, if applicable. 

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
P3.1 : 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
P4.1 : 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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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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