Transcript Clinical Quality Standards - Manufacturing Analysis, Inc.

George Bernstein, Ph.D.
Manufacturing Analysis Inc.
9/30/2008
Manufacturing
Analysis Inc
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The Problem
The Solution
Quality Standards vs. SOPs
Example Quality Standards
 Clinical Development
 Pharmacovigilance
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About Us
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Manufacturing
Analysis Inc
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Patchwork of low level SOPs and work instructions across
business units that perform same work
 Result of M&A
 Do not represent best practices
 Procedures are inconsistent in format, content, and in some cases
overlap and conflict with other procedures, or leave gaps
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Can become a compliance issue
Can add cost
 Redundant efforts to write/revise across sites
 Greater opportunity for documentation errors, deviations
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Manufacturing
Analysis Inc
Realign quality-related documentation
 Ist step
▪ Create quality standards
▪ Base quality standards on international standards (e.g.,
FDA, OECD, EMEA, ICH)
 2nd step
▪ Implement across businesses
 3rd step
▪ Quality standards form basis for restructuring and
rewriting of SOPs
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Manufacturing
Analysis Inc
Increasing level of detail
Documentation Hierarchy
Quality Policy
Quality Standards
Standard Operating
Procedures
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Manufacturing
Analysis Inc
Quality Standard
Module
SOP
SOP
Quality Standard
Module
SOP
Quality Standard
Module
SOP
SOP
SOP
Benefits of Quality Standards
• Alignment
• Eliminate overlap
• Eliminate gaps
• Provides guidance to SOP authors as to scope
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Manufacturing
Analysis Inc
1.
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Purpose and Scope
Responsibilities
Definitions/Abbreviations
Requirements
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
Process Summary (e.g., Visio flow chart)
General Requirements
Clinical Development Plan
Study Protocol
Clinical Trial Site Selection
Source Document Selection
Trial Drug Supply Management
Clinical Trial Registry
5 – 8 Change History, References, Annexes
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Manufacturing
Analysis Inc
1. Purpose and Scope
To identify the requirements for planning and preparing clinical trials of
_________ products.
This module applies to all __________ facilities that either by
international or local regulations have to follow GCP rules.
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Manufacturing
Analysis Inc
4.2 General Requirements
The following are required before a clinical trial can commence:
 Clinical Trial Development Plan
 Product Profile
 Study protocol
 Approved budget
 Trial sites/investigator selection
 Source documents
 Trial drug supplies
 Trial entry into the clinical trials registry
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Manufacturing
Analysis Inc
 Planning, Preparation, and Oversight of a Drug
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Development Program
Protection of Clinical Trial Subjects Including Subjects’
Rights and Privacy
Planning and Preparing Clinical Trials
Trial Drug Management
Clinical Study Execution
Data Management
Analysis and Reporting of Clinical and Preclinical Studies
Publication of Study Plans and Results
Fraud and Misconduct
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Manufacturing
Analysis Inc
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PV Organization
EU QPPV
Contract Management for Safety Information Exchange
Detailed Description of PV Systems
Information Security and Patient Rights to Privacy
Pre-Clinical Pharmacovigilance
Collection and Management of SAES from Clinical Studies
ICSRs
Expedited Reporting ISCRs
Periodic Reporting of Aggregate Safety Data
PV Databases
Collection, Analysis, Reporting of PV Safety Signals
Safety Risk Management
Compliance Monitoring
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Manufacturing
Analysis Inc
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Quality Audits
Quality Assurance Interactions with Regulatory Authorities
CAPA
Deviations and Investigations
Quality Control Requirements
Change Control
CROs
Generation of Third Party Contracts
Archiving
Records
Document Management
Qualification and Training of Personnel
Glossary – definitions and abbreviations
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Manufacturing
Analysis Inc
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Quality
 Capabilities range from developing corporate quality standards to FDA audit
remediation and SOP development in manufacturing, pre-clinical, clinical and
pharmacovigilance environments.
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Project Management
 Capabilities range from software development, implementation and Part 11
compliance to GxP construction, compliance, and training.
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Computer System Validation
 Capabilities range from enterprise-wide inventory and assessment to
IQ/OQ/PQ development and execution.
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Electronic Batch Records Systems
 Capabilities range from evaluation and implementation of commercial
systems to design and development of proprietary systems.
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Manufacturing
Analysis Inc
3 Clients to date
 Pre-clinical R&D
 38 Modules written
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Clinical Development
 28 Modules written
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Pharmacovigilance
 16 Modules written
 10 SOPs written
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Manufacturing
Analysis Inc
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Miles Labs
Bayer Biologicals
Ciba Geigy
Novartis Pharma
Novartis Vaccines and Diagnostics
Hoffmann La Roche
sanofi pasteur
WHP (OTC Manufacturer)
URL Pharma
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Manufacturing
Analysis Inc