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Validation is Always Part of the Picture. Commercial Manufacturing. Pre-IND. Phase I. Phase II. Phase III. Final process validation. Specification Development. Re-validation. Ongoing Validation (DOE, IQ, OQ, PQ, PV)*. * DOE = Design of Experiment IQ = Installation Qualification

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validation is always part of the picture
Validation is Always Part of the Picture

Commercial Manufacturing

Pre-IND

Phase I

Phase II

Phase III

Final process validation

Specification Development

Re-validation

Ongoing Validation

(DOE, IQ, OQ, PQ, PV)*

* DOE = Design of Experiment

IQ = Installation Qualification

OQ = Operational Qualification

PQ = Performance Qualification

PV = Process Validation

  • The extent of IQ, OQ, PQ, validation, etc. depends on complexity of product
  • 6 sigma target
gmp validation of new premises
GMPValidation of new premises

VALIDATION

Clean area

Premises

Utility

Systems

Manufacturing

SupportSyst.

Equipment

Manufacturing

Processes

  • HVAC System
  • LAF Units
  • Cold Storage
  • Env. Monitoring
  • Facility Cleaning
  • Transfer hatches
  • Verifi. of classific.
  • Water systems
  • Plant Steam
  • Pure/Clean Steam
  • Process Gases
  • Sterilizers
  • Depyrogenators
  • SIP Systems
  • CIP Systems
  • Washing
  • Waste Systems
  • Fermentors
  • Scales
  • Incubators
  • Filtration Units
  • Filling Equipment
  • Computerised
  • systems
  • Fermentation
  • Separation
  • Purification
  • Filtration
  • Filling

Aseptic

Processing

Packaging &

Labeling

In-Process

Control

Personnel

Training

Analytical

Methods

  • Process Measurem.
  • Visual Inspection
  • Label Control
  • Sampling
  • GMP
  • Gpwning valid..
  • SOPs
  • Equipment
  • Processes
  • Media Fills
  • Packaging
  • Labeling
  • Chemical - Cleaning valid
  • Physical - Sterility tests
  • Biological - Stability
slide7

Auditing & Inspection

Auditing & Inspection

slide16

1.0 Regional Administrative Information

1.1 ToC of Module 1 or overall ToC,

including Module 1

Module 1

1.0

2.1 ToC of the CTD (Mod 2,3,4,5)

2.2 Introduction

2.1

2.3 Quality Overall Summary

Module 2

2.2

2.4 Nonclinical Overview

2.4

2.5

2.5 Clinical Overview

2.3

2.6 Nonclinical Written and

Tabulated Summaries

2.6

2.7

2.7 Clinical Summary

Module 3

Module 4

Module 5

Nonclinical

Study Reports

Clinical

Study Reports

Quality

Structure of CTD

paper crf process
Paper CRF Process

Gather Data

Record on Source

Transcribe to CRF

File Copy of CRF

Monitor CRF

Updates to DM

Copy to DM

Data Processing

YES

Is Response OK?

To DM

Issue Queries to Sites

NO

Answer Query

Compare to Source

slide18
eCRF

Record on Source

Monitor e-CRF with Source

Gather Data

Transcribe to e-CRF

Answer on-line Queries

e-CRF Printed for Site Retention

Generate electronic Query

Approve e-CRF

Data Manager, Project Manager and Clinical Monitor Data (offline edit checks, manual review)

protocol development
Protocol Development

Stage

Review/Approval

Time Line

Investigator/IND Holder

Cooperative Group

1-6 Months

Protocol Concept

Department Review

Institutional Scientific Review

2-3 Months

Protocol Development

IND Holder

Institutional Review Board

Food and Drug Administration

2-3 months

Protocol Approval

Monitoring

Investigator

Institutional Review Board

Data Safety and Monitoring Board

IND Holder

Food and Drug Administration

2-6 years

Clinical Trial

the r d process
THE R&D PROCESS

Development

Preclinical studies

Clinical studies

18/09/2014

Discovery

Early Clinical

Development

CHEMISTRY/

PHARMA-COLOGY

IND*

PHASE I

PHASE II

PHASE III

NDA**

PHASE IV

Regulatory review

Efficacy studies on healthy volunteers

Clinical studies on a limited scale

Comparative studies on a large number of patients

Regulatory review

Continued comparative studies

Search for active substances

Toxicology, efficacy studies on various types of animals

*InvestigationalNew Drug

Application for permission to administer a new drug to humans

KNOWLEDGELEVEL

50–150persons

100–200patients

Registration, market introduction

500–5,000patients

KNOWLEDGELEVEL

**New Drug Application

Application for permission to marketa new drug

TIME SPAN

2–6 months

3–6 yrs.

1–3 yrs.

2–4 yrs.

Approximately 10–15 years from idea to marketable drug

72

early clinical drug development principle testing
Early Clinical Drug Development PRINCIPLE TESTING

FTIM

MS

1

2

3

4

5

5.5

6

7

8

9

Target

Id.

Hit

Id.

Lead

Id.

Lead

Opt.

Pre-

nom.

Preclin.

Dev.

Principle

Testing

Concept

testing

Dev. for Launch

Launch and PLC

Prod.

Maint.

TG

1

1.5

2

2.5

3

4

5

Key Activities:

  • Submission
  • Single Ascending Dose study
  • Multi Ascending Dose study
  • Proof of Principle studies
  • Manufacture route identification
  • Dev. formulation for concept testing & onwards
  • Dev. Patient Risk Management Plans
  • Achieved Objectives:
  • Safety
  • Effectiveness
  • Business Plan
  • Dose

Principle

Testing

1-3 years

74

edc drug development

Portal

Electronic Submissions

21 CFR Part 11 Compliance

Data Mining

Clintrial Connector

ClintrialeTrial

SDD Platform

Analysis and Reporting

OpenText

Opentext

Version Control

Reporting

eClinical

Biomedical Trial Data Warehouse

Web Hosting

Web Server

Oracle

Ad Hoc

Querying

ETLQ

(Defined Business Rules)

CROs

Regulatory Submission and Document Management

OLAP/Cubes

Desktop

Meta

Data

Metadata Management

Other

Access Engines

Data Quality, Cleansing, Validation, Aggregation, Enrichment

EDC Drug Development

Source Systems

sources of error in a study
Sources of Error in a Study

Omission, mis-communication

Transcription

Data entry errors

Programming, summary tables

Statistical interpretation

Clinical interpretation