Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries
1. Discussion Forum on ICH Q7 & Q11
Introduction
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
23 April 2017 (Program A)
21 May 2017 (Program B)
2. Not the view of
DRAP
Current
judgment
No obligation
on DRAP
Regulatory
experience
References US-FDA WHO ICH NRAs
DISCLAIMER
13. What is a Starting Material?
Contributes an important structural part of the API
Compound well defined in chemical literature (name, chemical
structure, chemical/physical properties, and impurity profile)
Synthesized by commonly known process
Q7
14. Re-defining Starting Material
Marks the Start of the Manufacturing Process
Manufacturing steps before are not described
Manufacturing steps before need not be performed with GMP
Changes in manufacturing steps before need not be reported to Agency
Each Branch of a Synthesis will begin with One or More Starting
Materials
Q7
15. What is an API?
A substance or compound that is intended to be used in the
manufacture of a pharmaceutical product as a therapeutically
active compound (ingredient)
Q7
16. API- DS, Characteristics
Elucidation of structure
Impurities
Specifications & its justification
Analytical procedure
Analytical method validation
Q7
17. API- DS, Characteristics
Potentially genotoxic impurities in DS
Atorvastatin exists in crystalline and
amorphous forms. The amorphous forms
are very sensitive to oxidation giving
various epoxide degradation products that
is considered a structural alert.
Q7
18. API- DS, Characteristics
Potentially genotoxic impurities in DS
Oxcarbazepin: Acridine derivatives are
potential degradation product of
oxcarabazepin that have some DNA
binding capabilities
Q7