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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

Product description

  • Dosage form and characteristics
  • Describe accompanying reconstitution diluents (if any)
  • Type of container and closure used for dosage form and reconstitution diluents (if applicable)

Product composition

  • Name, quantity stated in metric weight or measures (overages, if any), function and quality standard reference (pharmacopoeia/manufacturer’s) of all materials used in the vaccine formulation
  • To indicate minimum titer of the vaccine antigen(s) per mL and per dose.

Please refer:

ICH Q6B: Specifications: Test procedures and acceptance criteria for biotechnological/ biological products

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
P5.7 : Viral Inactivation / Removal Studies
P5.8 : Plasma Master File (PMF)
P5.9 : Certificate of Fitness for Purpose / Compliance Certificate / Plasma Quality Certificate
P5.10 : Batch Release Certificates
P5.11 : Summary Lot Protocol
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 (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

DISCLAIMER

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.

Site Last Modified

  • Last Modified: Khamis 10 Oktober 2024, 15:18:19.

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