Good Manufacturing Practices (Gmp) Pharmaceutical Industry

Certification course for Good Manufacturing Practices (GMP) in Pharmaceutical Food Industries

What you'll learn

Learn Quality Management System and Risk Management

Know the most important pharmaceutical regulations and their importance

Get a detailed overview of GMP requirements in the pharmaceutical industry

Learn the technical terms in the GMP area and their meanings.

Importance of GMP in the Manufacturing and Pharmaceutical Industry.

Learn the most important considerations for GMP audits

Learn Finished Pharmaceuticals General Provisions

Learn Production and Process Controls

Learn how to manage the clinical trials supplies

Master the key skills to outsource and find contractors

Pharmaceutical Facilities management

Requirements

A desire to learn all Good Manufacturing Practices

Description

Welcome to the complete Good Manufacturing Practice (GMP) course. This course is a complete guide for learning the most important requirements for following the GMP for the Pharmaceuticals and the Food Industry.  GMP or good manufacturing practices followed by businesses involved in manufacturing of cosmetics food and pharmaceutical products. It is designed to maintain quality during production. Not complying with the good manufacturing practices can result in poor product quality and distrust the production in your organization. This course will cover the following sections:Current Good Manufacturing PracticesThis section addresses Food and Drug Administration (FDA) and a few different federal policies which have been promulgated for statutory effectuation and implementation withinside the main. The most important statute underlying such policies is the Federal Food, Drug, and Cosmetic (FFDC) Act. This phase offers a particular hints and ideas which could function assessments for crucial operations in the complete employer just so powerful and incorporated great structures and product controls may be achieved. Each requirement this is loosely generalized in GMP policies may be enlarged and made greater precise as a way to encompass measures that the authors consider are essential for appropriate manipulate structures.Quality Management System and Risk ManagementThis section will cover the two recent Food and Drug Administration (FDA) Guidance Documents on Quality Systems Approaches: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, September 2006, Final Guidance and Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program 7356.002. These documents provide much insight into the FDA’s current thinking and change in approach since the introduction of their Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st century initiative. To understand quality systems in practice also requires knowledge of fundamental work processes and process management. This chapter will explore the intent of the guidance documents and application to pharmaceutical quality systems and processes.Management Responsibility and ControlRisk must be managed. There's no better approach than a purposeful management system that provides actionable data for your company to know where its day-to-day operations are at all times. This section provides a model for building a practical and effective management system to meet this expectation. I understand the rationale for FDA's requirement that administrators be responsible for oversight and control.Quality Control UnitIn this section we will focus on the Quality Control Unit. The QCU is an essential support function for the manufacturing process and the responsibilities are broad. A QCU must have adequate laboratory facilities to effectively carry out its duties. It is interesting that this is being done in the realm of quality authorities and not in the realm of general laboratory testing. This can be interpreted as permitting the use of external contract laboratories where competence or expertise is required, but these must be fully evaluated according to procedures and approved prior to use.Finished Pharmaceuticals General ProvisionsThe regulations in this section contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.Production and Process ControlsThis section provides a clear overview on how to write procedures, calculate yield and identify equipment. You will learn how to test your materials and drug products, how to control microbiological contaminations and reprocessing. Records and ReportsHere you will learn how to log and record all processes part of the GMP for Pharmaceuticals. You will be able to generate component, closure, batch/master production, lab and distribution records. You will master the development of use logs from equipment cleaning and the creation of complaint files. Clinical Trials SuppliesGood manufacturing practice (GMP) stands for good documentation, good housekeeping, and good scientific practices, regardless of the end-user of a drug. Unique requirements for test methods create opportunities for innovative approaches to regulatory compliance. Additionally, because of the potential problems with visually similar containers and packaging with similar labels, creatively incorporate current Good Manufacturing Practice (CGMP) principles and concepts into the clinical trial material (CTM) supply process. Adoption is just good business practice.Contracting and OutsourcingOne thing that is common to the small virtual company  and the multinational company marketing commercial product is that they both use contractors and outsource one or more operations. The section discusses different topics related to outsourcing manufacturing operations and can be adapted for individual processes that are outsourced to a contractor.Pharmaceutical FacilitiesLearn how to design and construct your pharmaceutical facility. We will cover all requirements for lighting ventilation, plumbing, washing, sanitation and more. You will be able to manage and maintain your facility and make sure it meets the FDA guidelines.EquipmentWe will look at the different types of equipment . You will learn how to construct, clean and maintain your equipment. We will cover automatic, electrical and mechanical equipment that you need in your facility. The development of Good Automation Manufacturing Practice (GAMP) guidelines and calibration program guidelines has substantially transformed the process used, not only for the procurement and qualification of computer systems but also the entire system for the acquisition of equipment and systems.

Overview

Section 1: Current Good Manufacturing Practices

Lecture 1 What are GMPS

Lecture 2 The Meaning of "Current"

Lecture 3 Specific Drug Categories and Topics

Section 2: Quality Management System and Risk Management

Lecture 4 Quality Management Systems and Risk management

Lecture 5 Key Process/Systems Elements

Lecture 6 Quality Risk Management

Section 3: Management Responsibility and Control

Lecture 7 Management Responsibility and Control

Lecture 8 The Quality Management Triad Model

Section 4: Quality Control Unit

Lecture 9 Responsibilities of Quality Control Unit

Lecture 10 Warning Letter Citations Specifically for QCU

Lecture 11 Expectations for Training and Training Systems in a GMP Environment

Lecture 12 Curricula

Lecture 13 Training Plans

Lecture 14 Instructional Design

Lecture 15 Qualified Trainers

Lecture 16 Records

Lecture 17 Contractors and Consultants

Section 5: Finished Pharmaceuticals General Provisions

Lecture 18 Dietary Supplements

Lecture 19 Homeopatic Drugs

Section 6: Production and Process Controls

Lecture 20 Written Procedures Deviations

Lecture 21 Charge-in of Components

Lecture 22 Equipment Identification

Lecture 23 Time Limitations on Production

Lecture 24 Validation of Aseptic Processing

Lecture 25 Validation of Ethylene Oxide Sterilization

Section 7: Records and Reports

Lecture 26 Records and Reports

Lecture 27 Equipment Cleaning and Use Log

Lecture 28 Batch Production and Control Records

Lecture 29 Events, Deviations and Investigations

Lecture 30 Details and More Details

Lecture 31 Distribution

Section 8: Clinical Trials Supplies

Lecture 32 Introduction

Lecture 33 Application of a CGMP Conceptual Model to CTM Production

Lecture 34 Equipment

Section 9: Contracting and Outsourcing

Lecture 35 Contracting and Outsourcing

Lecture 36 Outsourcing Process

Lecture 37 Other Types of Contractors

Section 10: Pharmaceutical Facilities

Lecture 38 Design and Construction Features

Lecture 39 Lighting

Lecture 40 Sanitation

Section 11: Equipment

Lecture 41 Introduction

Lecture 42 Maintenance and Calibration Process

Lecture 43 Calibration Programs

Lecture 44 Automatic, Mechanical and Electrical Equipment

Pharmaceutical industry professionals,Professionals interested in starting a career in the pharmaceutical industry,Manufacturing engineering students,Manufacturing professionals,CfPIEs,Professionals in the sphere of biology and chemistry,Graduates, Postgraduates and PhD. Students with pharmacy or medical degrees,Production managers and employees,Entrepreneurs or any professional working in food and/or drug manufacturing premises