Auditing

Key Benefits

You know where you stand before the regulatory agency tells you
You have the opportunity to proactively address non-conformances
You reduce the possibility of warning letters and hold points

Capabilities

Note: further details regarding audit syllabi are provided for underlined topics
GMPs
GLPs
GCPs
ISO 9000-9004
QS-9000
ISO 14000
Regulatory
Pre-Submission
Supplier/Vendor
FDA Applications Integrity (Fraud Policy)
Due Diligence
 
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QSRs
 
General Provisions (Subpart A)
Quality System Requirements (Subpart B)
Design Controls (Subpart C)
Document Controls (Subpart D)
Purchasing Controls (Subpart E)
Identification and Traceability (Subpart F)
Production and Process Controls (Subpart G)
Acceptance Activities (Subpart H)
Nonconforming Product Subpart I)
Corrective and Preventive Action (Subpart J)
Handling, Storage, Distribution, and Installation (Subpart K)
Packaging and Labeling Control (Subpart L)
Records (Subpart M)
Servicing (Subpart N)
Statistical Techniques (Subpart O)
Design Control Inspectional Strategy
General

Design and Development Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design transfer
Design Changes
Design History File
 
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GLPs
 
LABORATORY ORGANIZATION & MANAGEMENT
QUALITY ASSURANCE SYSTEM
QUALITY CONTROL SYSTEMS
LABORATORY PERSONNEL
ENVIRONMENT AND FACILITIES
EQUIPMENT
STANDARD OPERATING PROCEDURES (SOPs)/PROTOCOLS/TEST METHODS
HANDLING OF REAGENTS/SOLUTIONS AND TEST/CONTROL ARTICLES
STUDY CONDUCT
REPORTS
RECORD RETENTION
SUBCONTRACTED/OUTSIDE SUPPORT, SERVICES, AND/OR SUPPLIES
COMPLAINTS

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GCPs
 
Investigator Site Audit
Evaluation and Initiation of Study
Responsibilities of Sponsor/Monitor
Responsibilities of Investigator
Informed Consent
Regulatory Documents
Mid-Study (Monitoring)
Close-Out of Study
 
CRO Audit
Selection of CRO

Phase 1 Units
Close-Out of Study
Laboratory Audit

IRB Audit

Sponsor Audit

Clinical Investigation

Biopharmaceutics
Computer Systems Validation
 
 
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ISO 9000-9004
Management Responsibility
Quality System
Contract Review
Design Control
Document and Data Control
Purchasing
Control of Customer-supplied Product
Product Identification and Traceability
Process Control
Inspection and Testing
Control of Inspection, Measuring and Test Equipment
Inspection and Test Status
Control of Nonconforming Product
Corrective and Preventive Action
Handling, Storage, Packaging, Preservation and Delivery
Control of Quality Records
Internal Quality Audits
Training
Servicing
Statistical Techniques
 
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QS-9000
ISO 9000 Based Requirements
Management Responsibility
Quality System
Contract Review
Design Control
Document and Data Control
Purchasing
Control of Customer-supplied Product
Product Identification and Traceability
Process Control
Inspection and Testing
Control of Inspection, Measuring and Test Equipment
Inspection and Test Status
Control of Nonconforming Product
Corrective and Preventive Action
Handling, Storage, Packaging, Preservation and Delivery
Control of Quality Records
Internal Quality Audits
Training
Servicing
Statistical Techniques
 QS-9000 Sector Specific Requirements
Production Part Approval Process
Continuous Improvement
Manufacturing Capabilities
 
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ISO 14000
 
Standard  Title / Description 
14000 Guide to Environmental Management Principles, Systems and Supporting Techniques 
14001  Environmental Management Systems - Specification with Guidance for Use
14010  Guidelines for Environmental Auditing - General Principles of Environmental Auditing
14011 Guidelines for Environmental Auditing - Audit Procedures-Part 1: Auditing of Environmental Management Systems
14012 Guidelines for Environmental Auditing - Qualification Criteria for Environmental Auditors
14013/15 Guidelines for Environmental Auditing - Audit Programs, Reviews & Assessments
14020/23 Environmental Labeling
14024 Environmental Labeling - Practitioner Programs - Guiding Principles, Practices and Certification Procedures of Multiple Criteria Programs
14031/32 Guidelines on Environmental Performance Evaluation
14040/43 Life Cycle Assessment General Principles and Practices
14050 Glossary
14060 Guide for the Inclusion of Environmental Aspects in Product Standards
 

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Regulatory
 
Information Control
Device Listing
IDE
510(K)
PMA's
Custom Devices
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Pre-Submission

 

(Click on the above title)

 
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Supplier/Vendor

This type of assessment is unique to each occasion. The criteria is agreed upon between Sequitur and our client prior to the assessment.

 

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FDA Applications Integrity (Fraud Policy)
Internal Review
Problems analysis as stated by FDA
Audit Plan
Purpose
Person Developing Plan
Content
  • Scope
  • Controls to Assure Impartiality
  • Qualifications of Consultant
  • Projected time frames of Audit
  • Specifications of Final Audit Report
Audit per audit plan
 
Nonclinical and Clinical Studies
  • Protocol
  • Study Report
  • Specimen Examination
Manufacturing Processes
  • Personnel
  • Raw materials, components, ingredients
  • Test Records
  • Production and Process Records
  • Equipment
In Vivo Bioequivilence and Bioavailability Studies
 
Audit Report

Corrective Action Operating Plan

 Content
  • Audit findings analysis
  • Disposition of auditor's recommendations
  • Description of actions to correct fraud/other wrongful acts ID'd by FDA/discovered by internal review
  • Implementation timetable
  • ID of Persons responsible for timely corrective actions
  • Ethics Program describing standards/procedures for employees about program and for enforcing program
  • Procedures for monitoring effectiveness of operating plan and to assure product will be built per GMPs and other applicable requirements
  • Plan to train Supv, tech and scientific employees in FD&C Act, and 18 USC 1001
Implementation

Verification

 

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Due Diligence

This type of assessment is unique to each occasion. The criteria is agreed upon between Sequitur and our client prior to the assessment
 

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Copyright © 1998 Sequitur Associates
Last modified: Aug 30, 1998