International Council for Harmonization (ICH)

An overview on Quality (Q1A to Q1F)

Obaid AliCivil Service Officer, Member, ISPE, PDA

26 March 2017

Not the view of DRAP

Current judgment

No obligation on DRAP

Regulatory experience

D

I

S

C

L

A

I

M

E

R

References US-FDA WHO ICH NRAs

Stability Q1A – Q1F

Analytical ValidationQ2

Impurities Q3A – Q3C

Pharmacopoeias Q4A – Q4D

Quality of Biotechnological Products Q5A-Q5E

Specifications Q6A – Q6B

Good Manufacturing Practices (API) Q7

Pharmaceutical DevelopmentQ8

Quality Risk Management Q9

Pharmaceutical Quality System Q10

Development & Manufacturing of DSQ11

Lifecycle Management Q12

Cross cutting topics covered under

Multidisciplinary

e.g. Common Technical Document

Q1A (R2)

Stability Testing of New Drug Substance & Products

Feb 2003

EC

March 2003

Canada Sep

2003

FDA Nov 2003

Japan Jun

2003

Stability Testing

Protocol for

Global Dossier

Temperature

DurationHumidity

I II

III IV

Q1B

Photo-Stability Testing of New Drug Substance & Products

Nov 1996

EC

Dec 1996

FDA May 1997

Canada Feb

1999

Japan

May 1997

Stability Testing

Protocol required

to Evaluate

Light Sensitivity

Q1C

Stability Testing for New Dosage Forms

Nov 1996

EC Dec 1996

FDA May 1997

Canada Jan

1999

Japan May 1997

Stability Testing

Protocol for New

Formulation &

Circumstances

where Flexibility

exists for reduced

data

Q1D

Bracketing & Matrixing Design for Stability Testing of New

Drug Substance & Products

Feb 2002

EC

Feb 2002

FDA Jan

2003

Canada Sep

2003

Japan July 2002

General Principle

for Reduced

Testing

Q1E

Evaluation of Stability Data

Feb 2003

EC March 2003

FDA Jan

2003

Canada Sep

2003

Japan June 2003

Extrapolation of

Retest

Periods/Shelf Life

beyond Real Time

Data may be

Appropriate

Statistical Approaches

Data Analysis

Q1F

Stability Data Package in Climate Zone III & IV

Jun 2006

Withdrawn 2006

Withdrawn FDA Jun

2006

Withdrawn

Japan July 2006