Table of Contents
ICH Q7A GMP Guidance for APIs and its Use During Inspections
Processes Covered During API Inspections Abroad - FY 2001
Program Objectives
Agenda
Agenda
Agenda
Questions on ICH Q7A?
What Is ICH?
What Is ICH?
ICH Members
ICH Technical Topics
PPT Slide
The ICH Process For Harmonization Of Guidance
For Additional Information On ICH
Availability of Q7A Guidance on the Internet
What Is an Intermediate?
What Is an Active Pharmaceutical Ingredient?
What Is an Active Pharmaceutical Ingredient?
Regulatory Status of APIs Abroad
Regulatory Status of APIs in the United States
Regulatory Status of APIs in the United States
Regulatory Status of APIs in the United States
API GMP Guidance Initiatives Incorporated Into Q7A
Importance of Q7A
Importance Of Q7A
PPT Slide
PPT Slide
Characteristics of API Processes
Characteristics of Drug Product Processes
PPT Slide
Uniqueness of API Processes
When Inspecting or Auditing API Manufacturers
Implementation Of Q7A
Implementation Of Q7A
Implementation Of Q7A
Implementation Of Q7A
Q7A Industry Guidance Disclaimer
FDA’s Implementation of Q7A
FDA’s Implementation of Q7A
Status Of Q7A With Respect To Other Documents
Use of Q7A During API Inspections
Use of Q7A During API Inspections
Section 1.3 Scope
Section 1.3 Scope
Section 1.3 Scope
Section 1.3 Scope
Q7A Does Not Address
Section 1.1 Meaning Of “Should”
Section 1.1 Meaning Of “Should”
Table 1 Applying Q7A
Applying Q7A
Applying Q7A
Designating Where API Production Begins
Designating Where API Production Begins
Definition API Starting Materials
Definition API Starting Materials
Important Clarification!
Why Initiate GMP Controls With Use of API Starting Materials?
Spectrum of CGMP Controls in API Manufacturing
USP Expectations Process Water Quality
Section 4.3 Process Water Quality
Section 4.3 Process Water Quality
Section 4.3 Process Water Quality
Section 8.4 Blending of Intermediates/APIs
Section 8.4 Blending of Intermediates/APIs
Section 8.4 Blending of Intermediates/APIs
Section 8.4 Blending of Intermediates/APIs
Sections 8.4 Blending of Intermediates/APIs
Sections 8.4 Blending of Intermediates/APIs
Section 8.4 Blending of Intermediates/APIs
Section 8.4 Blending of Intermediates/APIs
Section 8.4 Blending of Intermediates/APIs
Section 8.1 Critical Operations
Section 8.1 Process Deviations
Section 8.2 Time Limits
Section 8.2 Time Limits
Section 8.3 In-Process Sampling & Controls
Section 8.3 In-Process Sampling & Controls
Section 8.3 In-Process Sampling & Controls
Section 8.3 In-Process Sampling & Controls
Section 8.3 In-Process Sampling & Controls
Process Validation Dosage Forms Vs. APIs
Definition Of Critical
Section 12.1 Validation
Examples of Process Parameters
Section 12.4 Prospective Validation
Section 12.4 Concurrent Validation
Section 12.4 Concurrent Validation
Section 12.4 Retrospective Validation
Section 12.4 Retrospective Validation
Section 12.4 Retrospective Validation
Section 12.4 Retrospective Validation
Section 12.6 Periodic Review-Validated Systems
Section 19.6- Validation of APIs Used In Clinical Trials
Section 19.6 – Validation of APIs Used In Clinical Trials
Section 11.2 Impurity Profiles
Section 11.2 Impurity Profiles
Section 11.2 Impurity Profiles
Section 11.2 Impurity Profiles
Reprocessing And Reworking
Definition of Reprocessing
Definition of Reworking
Reprocessing Vs. Reworking
Section 14.2 Reprocessing
Section 14.2 Reprocessing
Sections 14.3 Reworking
Sections 14.3 Reworking
Sections 14.3 Reworking
Section 14.4 Recovery Of Materials/Solvents
Definition Of Mother Liquor
Section 14.4 Recovery Of Materials/Solvents
Section 14.4 Recovery Of Materials/Solvents
Q7A Summary
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