ICH Q7A GMP Guidance for APIs and its Use During Inspections

8/20/2002
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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
Author: Edwin Rivera Martinez
Home Page: http://www.fda.gov/cder/workshop.htm
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Guidance for IndustryQ7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
[PDF version of this document]
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)August 2001ICH
Additional copies are available from:
Office of Training and CommunicationsDivision of Communications ManagementDrug Information Branch, HFD-2105600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573(Internet) http://www.fda.gov/cder/guidance/index.htm
or
Office of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448Internet: http://www.fda.gov/cber/guidelines.htmFax: 1-888-CBERFAX or 301-827-3844Mail: the Voice Information System at 800-835-4709 or 301-827-1800
August 2001
ICH
Table Of Contents
I. INTRODUCTION (1)
A. Objective (1.1)B. Regulatory Applicability (1.2)C. Scope (1.3)
II. QUALITY MANAGEMENT (2)
A. Principles (2.1)B. Responsibilities of the Quality Unit(s) (2.2)C. Responsibility for Production Activities (2.3)D. Internal Audits (Self Inspection) (2.4)E. Product Quality Review (2.5)
III. PERSONNEL (3) 8
A. Personnel Qualifications (3.1)B. Personnel Hygiene (3.2)C. Consultants (3.3)
IV. BUILDINGS AND FACILITIES (4)
A. Design and Construction (4.1)B. Utilities (4.2)C. Water (4.3)D. Containment (4.4)E. Lighting (4.5)F. Sewage and Refuse (4.6)G. Sanitation and Maintenance (4.7)
V. PROCESS EQUIPMENT (5)
A. Design and Construction (5.1)B. Equipment Maintenance and Cleaning (5.2)C. Calibration (5.3)D. Computerized Systems (5.4)
VI. DOCUMENTATION AND RECORDS (6)
A. Documentation System and Specifications (6.1)B. Equipment Cleaning and Use Record (6.2)C. Records of Raw Materials, Intermediates, API Labeling and Packaging Materials (6.3)D. Master Production Instructions (Master Production and Control Records) (6.4)E. Batch Production Records (Batch Production and Control Records) (6.5)F. Laboratory Control Records (6.6)G. Batch Production Record Review (6.7)
VII. MATERIALS MANAGEMENT (7)
A. General Controls (7.1)B. Receipt and Quarantine (7.2)C. Sampling and Testing of Incoming Production Materials (7.3)D. Storage (7.4)E. Re-evaluation (7.5)
VIII. PRODUCTION AND IN-PROCESS CONTROLS (8)
A. Production Operations (8.1)B. Time Limits (8.2)C. In-process Sampling and Controls (8.3)D. Blending Batches of Intermediates or APIs (8.4)E. Contamination Control (8.5)
IX. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES (9)
A. General (9.1)B. Packaging Materials (9.2)C. Label Issuance and Control (9.3)D. Packaging and Labeling Operations (9.4)
X. STORAGE AND DISTRIBUTION (10)
A. Warehousing Procedures (10.1)B. Distribution Procedures (10.2)
XI. LABORATORY CONTROLS (11)
A. General Controls (11.1)B. Testing of Intermediates and APIs (11.2)C. Validation of Analytical Procedures - See Section 12. (11.3)D. Certificates of Analysis (11.4)E. Stability Monitoring of APIs (11.5)F. Expiry and Retest Dating (11.6)G. Reserve/Retention Samples (11.7)
XII. VALIDATION (12)
A. Validation Policy (12.1)B. Validation Documentation (12.2)C. Qualification (12.3)D. Approaches to Process Validation (12.4)E. Process Validation Program (12.5)F. Periodic Review of Validated Systems (12.6)G. Cleaning Validation (12.7)H. Validation of Analytical Methods (12.8)
XIII. CHANGE CONTROL (13)
XIV. REJECTION AND RE-USE OF MATERIALS (14)
A. Rejection (14.1)B. Reprocessing (14.2)C. Reworking (14.3)D. Recovery of Materials and Solvents (14.4)E. Returns (14.5)
XV. COMPLAINTS AND RECALLS (15)
XVI. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES) (16)
XVII. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS (17)
A. Applicability (17.1)B. Traceability of Distributed APIs and Intermediates (17.2)C. Quality Management (17.3)D. Repackaging, Relabeling, and Holding of APIs and Intermediates (17.4)E. Stability (17.5)F. Transfer of Information (17.6)G. Handling of Complaints and Recalls (17.7)H. Handling of Returns (17.8)
XVIII. SPECIFIC GUIDANCE FOR APIs MANUFACTURED BY CELL CULTURE/FERMENTATION (18)
A. General (18.1)B. Cell Bank Maintenance and Record Keeping (18.2)C. Cell Culture/Fermentation (18.3)D. Harvesting, Isolation and Purification (18.4)E. Viral Removal/Inactivation steps (18.5)
XIX. APIs FOR USE IN CLINICAL TRIALS (19)
A. General (19.1)B. Quality (19.2)C. Equipment and Facilities (19.3)D. Control of Raw Materials (19.4)E. Production (19.5)F. Validation (19.6)G. Changes (19.7)H. Laboratory Controls (19.8)I. Documentation (19.9)
GLOSSARY (20)
Guidance for Industry1
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

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