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

About Us

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Manufacturing Analysis Inc

   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 Can become a compliance issue Can add cost  Redundant efforts to write/revise across sites  Greater opportunity for documentation errors, deviations 3

Manufacturing Analysis Inc

Realign quality-related documentation

   Ist step ▪ Create quality standards ▪ Base quality standards on international standards (e.g., FDA, OECD, EMEA, ICH) 2 nd ▪ step Implement across businesses 3 rd ▪ step Quality standards form basis for restructuring and rewriting of SOPs

Manufacturing Analysis Inc

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Documentation Hierarchy

Quality Policy Quality Standards Standard Operating Procedures

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Manufacturing Analysis Inc

Quality Standard Module Quality Standard Module SOP SOP SOP SOP SOP

Benefits of Quality Standards • Alignment • Eliminate overlap • • Eliminate gaps Provides guidance to SOP authors as to scope

Quality Standard Module SOP

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Manufacturing Analysis Inc

1.

2.

Purpose and Scope Responsibilities 3.

4.

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 7

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 9

Manufacturing Analysis Inc

         Planning, Preparation, and Oversight of a Drug 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 10

Manufacturing Analysis Inc

              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 11

Manufacturing Analysis Inc

             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 12

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.

Project Management

 Capabilities range from software development, implementation and Part 11 compliance to GxP construction, compliance, and training.

Computer System Validation

  Capabilities range from enterprise-wide inventory and assessment to IQ/OQ/PQ development and execution.

Electronic Batch Records Systems Capabilities range from evaluation and implementation of commercial systems to design and development of proprietary systems.

Manufacturing Analysis Inc

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3 Clients to date

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Pre-clinical R&D

  38 Modules written

Clinical Development

  28 Modules written

Pharmacovigilance

 16 Modules written  10 SOPs written 14

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