GMP Publications - Code of Federal Regulation Handbooks by the FDA

ICH Q7 with Q7 Auditors Check List

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1-933734-82-5

ICH Q7 is a worldwide harmonized GMP guideline for active pharmaceutical ingredients (chemical and biological), which covers all GMP aspects of manufacturing, quality control and trading. ICH Q7 - GMP for APIs This document was abstracted by the International Conference of Harmonisation (ICH).

Pharmaceutical manufacturers should know this guideline to make sure that their suppliers are in compliance with the necessary GMP rules. Includes the ICH Q7 Auditor's Checklist.

Table of contents:

  • Introduction
  • Quality Management
  • Personnel
  • Buildings and Facilities
  • Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and In-Process Controls
  • Packaging and Identification Labelling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Rejection and Re-Use of Materials
  • Complaints and Recalls
  • Contract Manufacturers (including Laboratories)
  • Agents, Brokers, Traders, Distributors, Repackers and Relabellers
  • Specific Guidance for APIs Manufactured by Cell Culture/Fermantation
  • APIs for Use in Clinical Trials
  • Glossary
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2 Day Drug GMP Boot Camp Conference - June AC

Don't just get the books, Get the Training!

2 Day Pharmaceutical Drug GMP Boot Camp

(21 CFR Part 211 with ICH Q7 API)

'cGMP Training from the Auditor's Perspective'

18 - 19 June, 2018 - Atlantic City, New Jersey


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Sheraton Atlantic City Convention Center Hotel
2 Convention Boulevard, Atlantic City, NJ 08401
www.sheratonatlanticcity.com

All Boot Camps Conferences Includes:

  • GMP Seminar Binders
  • Handbooks
  • Certificates of Attendance
  • Breakfast, Lunch and Refreshments
Day 1 Topics

- Breakfast and Opening Introductions

- GMP 101 The Basics (Satisfies the annual GMP Training Requirements)

- 21 CFR Part 11 Basic Overview

  • 21 CFR Part 11 Definitions, System Types and Classifications
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • Part 11.10 Sections a) - k)
    • (a) Validation
    • (b) Copies of records
    • (c) Protection of records
    • (d) Limiting system access
    • (e) Audit trails
    • (f) Operational system checks
    • (g) Authority checks (h) Device checks
    • (i) Education, Training, Experience
    • (j) Policies and Procedures
    • (k) Systems documentation
  • Risk Analysis - Determine Which Systems Need to be Validated
  • Steering Committee and Charters

- Lunch

- 21 CFR Parts 210/211 Drug GMPs - (with ICH Q7 - API Correlations)

  • GMPs - The Basics - Quality Definitions, CAPA, Deviations, Non-Conformance
  • Organizational & Management Responsibilities
  • Document Control Program
  • Employee Orientation, Quality Awareness, and Job Training
  • Plant Safety and Security
  • Internal Quality/GMP Training Session Program
  • Quality Cost Program
  • Design Control
  • Facility Design and Layout
  • Environmental Control Program
  • Facility Maintenance and Good
  • Housekeeping Program
  • Outside Contractor Control Program
  • Equipment Design and Placement
  • Equipment Identification
  • Equipment Maintenance & Cleaning
  • Measurement Equipment Calibration Program
  • Equipment Qualification Program
  • Material/Component Specification and Purchasing Control
  • Material/Component Receipt, Inspection, Sampling, and Laboratory Testing
  • Material Component Storage and Handling
  • Inventory Control Program Vendor (Supplier) Control Program
  • Material/Component/Label Verification, Storage, and Handling
  • Equipment/Line/Area Cleaning, Preparation, and Clearance
  • Operational Process Validation and Production Change Order Control

 

Day 2 Topics

- Breakfast

- 21 CFR Parts 210/211 Drug GMPs (Cont.)

  • In-Process Inspection, Sampling, and Laboratory Control
  • Reprocessing/Disposition of Materials
  • Finished Product Verification, Storage, and Handling
  • Finished Product Inspection, Sampling, Testing, and Release for Distribution
  • Complaint Handling and Customer Satisfaction Program
  • Operational Process Validation and Production Change Order Control
  • In-Process Inspection, Sampling, and Laboratory Control
  • Reprocessing/Disposition of Materials
  • Finished Product Verification, Storage, and Handling
  • Finished Product Inspection, Sampling, Testing, and Release for Distribution
  • Distribution Controls
  • Marketing Controls

- Lunch

- Recall and Traceability

- cGMP for Sterile Drug

- ICH Q9 Quality Risk Management

- ICH Q10 Pharmaceutical Quality System

- cGMP for Phase 1 Clinical

- Questions and Answers

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