The Complete Pharmaceutical Production Course

API’S, Formulations, Data Integrity, ALCOA+, cGMP, Packaging, IPQA, QMS

What you’ll learn
Introduction to Pharma Industry-Types of formulations
USFDA Guidelines to be followed and their importance in industry.
cGMP regulations
Good documentation practices, Data Integrity and ALCOA Principles
Importance of Line clearance procedures
Manufacturing of API’s
Manufacturing of formulations
Packing of various formulations.
Various equipment’s used for packing
Role and importance of IPQA in the manufacturing and packing.
Batch release procedure into market

Requirements
Basic Knowledge on Pharmaceutical industry
Basic level of English
Good quality of internet connection, Desktop /Laptop/Smartphone required(Since dealing with online mode

Description
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.Below topics will cover in this course- Introduction to Pharma Industry-Types of formulations-USFDA Guidelines to be followed and their importance in industry. -USFDA Guidelines to be followed and their importance in industry. -cGMP regulations -Good documentation practices, Data Integrity and ALCOA Principles -Importance of Line clearance procedures -Introduction to manufacturing of APIs -Discussion on various equipment’s used in manufacture of APIs—session1. -Discussion on various equipment’s used in manufacture of APIs—session2. -Manufacturing process of APIs -Introduction to manufacturing of OSDs -Discussion on various equipment’s used in manufacture of OSDs—session1. -Discussion on various equipment’s used in manufacture of OSDs—session2. -Granulation processes Day-14: Manufacturing process of Tablets -Manufacturing process of liquids and semisolids -Manufacturing process of capsules -Introduction to manufacturing of sterile formulations, Discussion on clean room conditions -Discussion on various equipment’s used in manufacture of steriles -Manufacturing process of various sterile formulations -Introduction to packing of various formulations. -Discussion on various equipment’s used for packing-Discussion on various checkpoints during packing -Role and importance of IPQA in the manufacturing and packing.-Batch release procedure into market

Overview
Section 1: Introduction

Lecture 1 Introduction to Pharma Industry-Types of formulations

Lecture 2 USFDA Guidelines to be followed and their importance in industry

Lecture 3 Common GMP deficiencies during sampling and manufacturing

Lecture 4 Common GMP deficiencies during packaging

Lecture 5 Good documentation practices, Data Integrity and ALCOA Principle

Lecture 6 Importance of Line clearance Procedures

Section 2: Manufacturing of API’S

Lecture 7 An Introduction to Manufacturing of API’s # Class-1

Lecture 8 Manufacturing of API’s – Reactors

Lecture 9 Manufacturing of API’s-Centrifuge

Lecture 10 Manufacturing of API’s-Driers

Lecture 11 Manufacturing of API’s – Tray Dryer, Jet mill & Sifter

Lecture 12 Manufacturing of API’s- Blender & API Manufacturing process

Section 3: Manufacturing of Various Formulations

Lecture 13 An Introduction to Manufacturing of Solid Dosage Forms

Lecture 14 Discussion on various equipment’s used in manufacture of OSDs—session1

Lecture 15 Discussion on various equipment’s used in manufacture of OSDs—session2

Lecture 16 Manufacturing process of Tablets

Lecture 17 Manufacturing process of liquids and semisolids

Lecture 18 Manufacturing process of capsule

Lecture 19 Introduction to manufacturing of sterile formulations, Discussion on clean room

Lecture 20 Discussion on various equipment’s used in manufacture of steriles

Lecture 21 Evaluation of tablets

Lecture 22 Introduction to packing of various formulations.

Lecture 23 Discussion on various checkpoints during packing

Lecture 24 Role and importance of IPQA in the manufacturing and packing.

Lecture 25 Batch release procedure into market

Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences,Graduate or postgraduate degree in Chemistry,Graduate or postgraduate degree in Life sciences