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CTD Implementation by DRA-Pakistan
1. CTD Implementation by DRAP
Presented By:
Rashid Mureed
Head OF Regulatory Affairs-OBS Group
2. DRUG REGULATORY AUTHORITY OF PAKISTAN
âș SRO. 932(I)/2017
âș Enforcement of CTD (Common
Technical Document) as Standard
Dossier Document for Applying Drug
product Registration in DRAP
âș Implementation Date: 01-01-2018
3. What is CTD
âș CTD stand of Common Technical Document
âș A CTD is a set of Technical Document required by International Regulatory
Agencies /HAâs for the purpose of Granting Marketing Authorization of a
Pharmaceutical Product in their respective countries.
âș In Now days these CTD based Technical documents are included in the
Application Dossier for Registration/Renewal of Pharmaceutical Products for
Human use.
4. History of CTD
âș Before CTD Regulators from Different countries HA receives a Dossier
application and spends about 2 to 3 Years in its review before giving any
decision for its approval of Marketing Authorization for use in Human Beings.
âș Reason for such delay was more on ambiguity based on different types of
technical documents in which a Application Dossier were submitted by different
Pharmaceutical Companies.
âș To harmonize these ambiguity Industries came up with CTD-Documents in
order to speed up Regulatory Approvals.
7. Nations/Region who first adopted CTD
CTD IS A JOINT EFFORT OF 3 REGULATORY AGENCIES:
1.European Medicines Agency (EMEA, Europe),
2. Food and Drug Administration (FDA, USA) and
3. Ministry of Health, Labour and Welfare (MHLW,Japan)
And there Pharmaceutical associations
8. Current CTD Accepting Regions
âș USA
âș CANADA
âș EUROPE
âș AUSTRALIA
âș JAPAN
âș AFRICA
âș ASEAN
âș CHINA
19. MODULE-3 (S PART DETAIL)
Module
Section
Document required as per ICH (DMF Part) Reference ICH Availability of Docs
3.2.S Drug Substance DMF documents on CTD
format req.
3.2.S.1 General Information Q6Q Do
3.2.S.2 Manufacturing Details Closed Part
(Q6A/Q3A)
Do
3.2.S.3 Characterization of Structure & Impurities Q3A(R),Q3C,Q6A Do
3.2.S.4 Control of Drug Substance Q3A(R),Q3C,Q6A
Q2A,Q2B,Q6B
Do
3.2.S.5 Reference Standards of Materials Q6A Do
3.2.S.6 Container Closure System Q6A Do
3.2.S.7 Stability studies Q1A(R2)/Q1B Do
20. MODULE-3 (P PART DETAIL):
Module
Section
Documents required as per ICH Reference ICH Availability of Docs
3.2.P.1 Description and Composition of the Drug Product Q6A Present
3.2.P.2 Pharmaceutical Development Q8 Document required
From NPD Dept.
3.2.P.2.1 Components of the Drug Product do
3.2.P.2.1.1 Drug Substance do
3.2.P.2.1.2 Excipients do
3.2.2.2 Drug Product do
3.2.P.2.2.1 Formulation Development do
3.2.P.2.2.2 Overages do
3.2.P.2.2.3 Physicochemical and Biological Properties do
3.2.P.2.3 Manufacturing Process Development do
3.2.P.2.4 Container Closure System do
3.2.P.2.5 Microbiological Attributes do
3.2.P.2.6 Compatibility do
21. MODULE-3(P PART-DRUG PRODUCT):
Module
Section
Document Required as Per ICH Reference ICH Availability of Docs
3.2.P.3 Manufacture Â
3.2.P.3.1 Manufacturer(s) Â Mfg. Address
3.2.P.3.2 Batch Formula  Present
3.2.P.3.3 Manufacturing Process and Process Controls  Present
3.2.P.3.4 Controls of Critical Steps and Intermediates Q2A, Q2B, Q6A Not available
3.2.P.3.5 Process Validation and/or Evaluation Not available for under
registered generics
3.2.P.4 Control of Excipients
3.2.P.4.1 Specifications Q6A Excipient control document
3.2.P.4.2 Analytical Procedures Q2A,Q6A do
3.2.P.4.3 Validation of Analytical Procedures Q2A, Q2B Not available for under
registered generics
3.2.P.4.4 Justification of Specifications Q3C No control document available
3.2.P. 4.5 Excipients of Human or Animal Origin Q6B TSE/BSE Certificate required if
any
3.2.P.4.6 Novel Excipients Undertaking req.
22. MODULE-3: (DRUG PRODUCT)
Module
Section
Documents required as per ICH Reference ICH Availability of Docs
3.2.P.5 Control of Drug Product -
3.2.P.5.1 Specification(s) Q3B(B),Q6A Present
3.2.P.5.2 Analytical Procedures Q2A,Q6A do
3.2.P.5.3 Validation of Analytical Procedures Q2A,Q2B Not Available for under
registered generics
3.2.P.5.4 Batch Analyses Q3C,Q6A do
3.2.P.5.5 Characterization of Impurities Q6A do
3.2.P.5.6 Justification of Specification(s) Q6A do
3.2.P.6 Reference Standards or Materials Q6A do
3.2.P.7 Container Closure System do
3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusion Q1A(R2),Q1B, Q1E do
3.2.P.8.2 Post-approval Stability Protocol & Stability
Commitment
Q1A(R2) do
3.2.P.8.3 Stability Data Q1A(R2),Q1B, Q1E do
23. GAP ANALYSIS:
Current Documents Required By DRAP
as per Form- 5F CTD:
Current Documents Providing Practice in
DRAP for dossier submission:
ï DMF (on CTD format) ï Product Formula
ï Product Development documents (Undertaking) ï Manufacturing Method
ï BMR of trial batches ï Finished Product Specification
ï Control of Critical Steps in Mfg. ï Finished Product Testing Methods
ï Mfg. Process Validation (Under Taking) ï API specification
ï Excipient Control Documents ï API testing methods
ï API & Excipient Supplier & Company COA (all documents are not on control format)
ï Analytical Validation of Finished Product
ï Finished Product COA
ï Stability Protocol, Summary, Conclusion, Post-
approval Stability Protocol, Stability Commitment
and 3 Batches stability data (on Long term 30/65
and Accelerated conditions 40/75)
24. GAP ANALYSIS:
Current Documents Required By DRAP as per
Form- 5F CTD:
Current Documents Providing Practice in
DRAP for dossier submission:
ï API working Std Certificates
ï Container closure system (Packaging
material specs., COAâs and analytical
procedures
ï BA/BE Studies
ï Comparative Study if bio waiver is applicable