Preparation for a Regulatory Pre-Approval Inspection

Abstract

A pre-approval inspection (PAI) is defined as a visit by one or more health agency investigators to review the adequacy and accuracy of the information provided in a regulatory submission seeking registration of a drug product to introduce into commerce. In this article a brief description with regard to critical elements of a PAI is provided in addition to a detailed description of Food and Drug Administration (FDA) requirements. PAI may also be generated by a centralized EMEA filing or a mutual recognition procedure.

Key words: :

• PAI-Pre Approval Inspection
• CTD-Common Technical Document
• Change Management System
• Drug Development
• Analytical Development
• Quality Assurance/Quality Control
• Audits

Notes

[1] Human and Veterinary Drugs, Current Good Manufacturing Practices in Manufacture Processing, Planning and Holding, preamble to the current Good Manufacturing Practices (cGMP),; 43, (190):45014–89

[2] Guidelines on the Preparation of Investigational New Drug (IND) Products (Human and Animals), 1991

[3] New Drug Evaluation Pre-Approval Audit Inspection. The FDA Compliance Program Guidance Manual on Pre-Approval Inspections/Investigations (7346.832), 1994, previous edition 1990) ID FDA 06698 and 06750)

[4] ICH Guideline M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use

[5] Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls section of an application, February 1987, FDA

[6] Draft Guidance for industry, Drug Product, Chemistry, Manufacturing and Controls information, January 2003, FDA

[7] 21CFR part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals¹—Office of the Federal Register National Archives and Records Administration, Subpart I, sections 211.160–211.194, April 2002;129–35

[8] Human Drug CGMP Notes, (2), 2Q/2002;10 (2): 2

[9] Human Drug CGMP Notes, 2Q/2001; 9 (2): 8