GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers

If you are unsure, help is here – the eighth edition of the GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. The QA manual has been revised to provide the audit system you need to assess for compliance with new standards and regulations and those that continue to be in effect.

Checklist Updated to Include:

• FDA's Approved (September 2006) Quality System Guideline For Drug Manufacturers
• FDA's 21 CFR Part 111 cGMP Dietary Ingredients and Supplements Regulation
• ISO 19011-2002 Guidelines For Quality And/Or Environmental Management System Auditing
• ISO 13485-2003 For Medical Device Quality Management Systems
• ISO 17025-2005 General Requirements For The Competence of Testing and Calibration Laboratories

Advantages to Using Checklists:

• FDA CONDONED!!! These checklists have been presented to FDA investigators with very positive results being obtained. It was an easy way to show them that a comprehensive audit program was in place.
• Standardizes audits and minimizes subjectivity amongst auditors
• Easy, objective and quantifiable results through use of a rating system
• Assures auditing for compliance to all applicable regulations and standards
• Enables auditors to trace questions to the requirements.

Contents of Manual

Narrative

A comprehensive explanation of the basic steps for preparing, performing, concluding and following up audits. Different types of audits are discussed, including the rationale and instructions for performing internal, contractor and supplier audits.

12 audit checklists

1. Device Manufacturer/Developer
2. Drug Manufacturer
3. Nutritional Manufacturer
4. Contract Device Manufacturer/Developer
5. Contract Drug Manufacturer
6. Contract Nutritional Manufacturer
7. Contract Software Developer
8. General Supplier
9. Chemical Supplier (including API’s)
10. Printed Material Supplier
11. Electronic Component Supplier
12. Simulated QSIT (FDA Approach) For Drug and Device Inspections

Checklist questions linked to the following applicable regulations/standards

• U.S. 21 CFR, Part 11, Electronic Records and Electronic Signatures
• U.S. 21 CFR, Sections 803.17 and 803.18 for Medical Device Reporting
• U.S. 21 CFR, Section 806.10 for Corrections and Removals (Recalls)
• U.S. 21 CFR Section 821.25 for Medical Device Tracking
• U.S. 21 CFR Section 820, Quality System Regulation (cGMP) For Medical Devices
• U.S. 21 CFR Section 211, cGMP for Finished Pharmaceuticals
• U.S. 21 CFR 1301-1307, Requirements for Controlled Drug Substances
• U.S. 21 CFR 111 cGMP for Dietary Ingredients and Supplements
• U.S. FDA & ICH Q7A GMP Guide for Active Pharmaceutical Ingredients
• U.S. FDA Guidance For Industry: Quality Systems Approach To Pharmaceutical cGMP Regulations
• IPEC GMP Guideline for Bulk Pharmaceutical Ingredients
• U.S. Military Specification Quality Program Requirements (MIL-Q-9858A) For Suppliers
• U.S. Military Standard 790, Product Assurance Program for Electronic and Fiber Optic Part Suppliers
• European Community (EC) Guide to Good Manufacturing Practices for Medicinal Products (includingAnnex 1 for Sterile Products and Annex 16 for Qualification/Validation)
• European Good Manufacturing Practices Guideline for Active Ingredient Manufacturers
• ISO 90003-2004 Guidelines For the Development, Supply and Maintenance of Software
• ISO 9001-2008 Quality Management System Requirements
• ISO 13485-2003 Medical Devices-Quality Management Systems
• ISO 17025-2005 General Requirements For The Competence of Testing and Calibration Laboratories
• ISO 19011-2002 Guidelines For Quality And/Or Environmental Management System Auditing

Rating System

• A rating system within each checklist so that you can answer each question with a value
• A rating system that gives you an overall compliance value for the audit.

A Compact Disc

• Contains all of the questions in Excel format
• Automatically tabulates rating results
• Allows you to download the checklists onto your computer
• Allows you to print blank or completed checklists