TECHNICAL REQUIREMENTS FOR CTD MODULE 3 (3.2.S/3.2.P)

Course Outline

Day One

Introduction

• Quality Terminologies & Acronyms
• CTD Overview
• EMA/ICHs/SFDA
• IPRP
• Pharmacopoeia (ICH Q4)
• Medicinal product submissions -International

Module 3 ICH,SFDA & EMA guidelines

Module 3.2.S

• Type of API submissions: ASMF/DMF & CEP
• 3.2.S (All CTD Modules):

1. API manufacturing process requirements & deficiencies
2. API elucidation of structure
3. Specifications (API & FPP) – parameters & limits: selection
4. Analytical procedures & validation of procedures (ICH Q2)
5. API potential & actual Impurities (organic, inorganic and genotoxic impurities, residual solvents, and heavy metals)

Module 3.2.S:

• Stability

Module 3.2.R

• 3.2.R.3 CEP/CPQ
• 3.2.R.2 & 3.2.R.4

QIS/QOS (3.2.R.8)

Day Two

Module 3.2.P

• 3.2.P (all CTD Modules)
• Pharmaceutical Development
• Manufacturing process & Process development

1. Executed and Master BMR
2. Process validation for FPP
3. Sterilisation
4. Ionizing radiation

Module 3.2.P

• Specifications – parameters & limits: selection
• Impurities/Degradation products
• Analytical procedures & Analytical Procedure Validation
• Container Closure System
• Stability

Module 2 link to Module 3

Specific types of products

If relevant and time permitting

• Biotechnology products: ICH Q5 & ICH Q6B
• ICH Q11
• ICH Q13
• ICH Q14

TRAINER: SALMA ISMAIL

B.Pharm. MSc (Med); MAP

Salma Ismail. With over 30 years experience & expertise in the Pharmaceutical Industry and in Regulatory Affairs and includes

Legislation, Technical issues, CMC Quality part, Marketing Regulations, Training within the Pharmaceutical industry and covers New

Chemical Entity, Generic and Biological submissions to regulatory authorities within the specific country.

Expertise in academia by lecturing on relevant Pharmaceutical Regulatory matters in Universities in South Africa.

In 2004, her entrepreneurial spirit motivated her to start up her own company – Twinz Regulatory Affairs Pharmacist Consultants. This

company has aided the social standing of the community at large with job creation with the current BBBEE level 1 status.

Twinz Regulatory Affairs Pharmacist Consultants have been instrumental in servicing pharmaceutical companies with new regulatory

submissions and amendments across the African continent with positive outcomes and assisted some of the world leading companies

by providing Regulatory based training to their staff enabling South African Regulatory Affairs on a whole to reach international standard.