Session 1 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 1

• Topic-1 Finished Medicinal Products
  In this lesson, we learn about medical products and the various ways drug products are administered.
• Topic-2 Focus on Patient Safety and Product Quality
  In this lesson, we will develop a deeper understanding of the importance of patient safety and product quality for medicines and medical devices.
• Topic-3 ISO9001:2008 and ISO 9001:2015
  This lesson is about the key requirements of a quality management system.
• Topic-4 Product Quality and Current Good Manufacturing Practices [cGMP]
  In this lesson, we learn how to scientifically define product quality. This lesson also gives an insight into the high-level principles of current good manufacturing practices (cGMP) including,

• • FDA – CFR – Code of Federal Regulations
  • PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICAL
  • EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
  • ICH Q7, Q8, Q9, and Q10 Quality Guidelines
  • PIC/S GMP Guide

Session 2 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 2

• Topic-5 API Regulatory Guidelines
  In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
• Topic-6 ISO-9001 ‘Continual Improvement’ & ICH Q10 Pharmaceutical Quality System
  This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.
• Topic-7 Quality Systems Approach to Pharmaceutical cGMP Regulations-The Quality Systems Mode
  In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations, and evaluation activities.
• Topic-8 FDA Medical Device Rules-CFR820
  In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
• Topic-9 Medical Device Regulations and Guidelines – ISO 13485 / CFR 820
  In this lesson, we look at some GMP regulatory and ISO guidance documents that are associated with the manufacture of medical devices.

Session 3 – Process & Cleaning Validation and Documentation

• Topic-1 Process Validation
  In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’ and ‘verification.
• Topic-2 ASTME2500 – Standard Guide for Specification, Design and Verification
  In this lesson, we will describe a specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.
• Topic-3 PQ, OQ and IQ
  In this lesson, we are going to define the terms installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and we will also list what typical project design documents are required to prepare such testing protocols.
• Topic-4 Cleaning Validation
  This class takes a high-level look at a typical cleaning validation sequence. It looks at how to determine the basis for quantification limits and explains how to determine cleanliness levels on the basis of the analytical testing of representative samples. Sampling is described in terms of sampling-equipment, sampling -locations, and sampling –procedures.

Session 4 – Risk Management Tools for Scientific Based Decisions

• Topic-5 Introduction to Quality Risk Management (QRM)
  In this lesson, we will develop an understanding of the history and the crucial importance of risk management as well as the basic steps involved in its application.
• Topic-6 Fault Tree Analysis (FTA) – step 4 ‘Workshop’ exercise
  In this lesson, we learn about the risk management tool ‘Fault Tree Analysis’ and see an example of where and how we can use it.
• Topic-7 Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC) – Step 4 ‘Workshop’ exercise
• This presentation shows an example of the main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and describes how this risk management technique summarizes the important modes of (a) failure, (b) factors causing these failures, and (c) the likely effects of these failures.
• Topic-8 Documenting the Quality Risk Management Process
  In this lesson, we take a practical look at managing a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk, and controlling risk.

Session 5 – Chemical and Biopharmaceutical Manufacturing

• Topic-1 Batch Organic Chemical Synthesis
  In this lesson, we describe the typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis
• Topic-2 Biopharmaceuticals Manufacturing, Upstream, Fermentation
  This lesson describes a conventional biotechnological process and introduces the following process sequences:
  • Stage-I – Upstream Processing
  • Stage-II – Fermentation / Bio-reaction
  • Stage-III – Downstream Processing

Session 6 – Tablet, Aseptic and Sterile Manufacturing

• Topic-1 Tablet Manufacturing
  In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
• Topic-2 Aseptic & Sterile Manufacturing
  In this lesson, we look at critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.

Write a 4-5 page essay, which you could present at a job interview to clearly demonstrate your Technical Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment. It will confirm your understanding of how to Manufacture Safe Medicines and Medical Devices in a GMP regulated environment and will include the following topics:

• The key requirements of a quality management system
• The manufacturing responsibilities for quality systems
• The cleaning validation sequence and how to determine cleanliness levels
• The documentation of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.
• The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
• The critical process parameters and quality attributes associated with the manufacture of tablets.
• The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
• The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

• 2.1 Protocol Content – Part-1: Objective, System Description and Scope
  In this lesson, we’ll start the process of developing a testing verification (qualification) protocol beginning with objective, system description and scope.
• 2.2 System Impact Assessment
  The objective of this lesson is to determine whether or not our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’ is a direct impact system in the context of product quality and patient safety.
• 2.3 Component Level Impact Assessment: Part-1 – Product Contact Components
  In order to begin determining the content of our testing verification (qualification) protocol, we need to establish which components have an impact on product quality and product safety. Here we begin by first taking a look at product-contact critical components.
• 2.4 Component Level Impact Assessment: Part-2 – Operationally Critical Components
  Determining the content of our testing verification (qualification) protocol we also need to establish which functions have an impact on product quality and product safety. In this lesson, we establish those operationally critical components.
• 2.5 cGMP Testing Principles
  This lesson considers high-level requirements when preparing a standard testing document.
• 2.6 Valves
  In this lesson, we take a look at valves as part of inline pipe fittings.
• 2.7 Piping (Line) List
  In this lesson, we are going to align the project piping (line) list against the P&ID.
• 2.8 Testing Traceability Matrix for Equipment System – First Pass
  In this lesson, we take our first look at the traceability matrix. This is a mechanism for tracing requirements through to the testing documents. Here we are using the matrix as a method to help plan necessary installation and functional/operational tests. We will also reference the project validation plan.

• 3.1 Protocol Content – Part-2: Responsibilities and Installation Testing
  Resuming with the process of developing our testing verification (qualification) protocol we continue with responsibilities and introduce installation-testing.
• 3.2 Minimum Elements of a Test Script
  Having already considered high-level requirements when preparing a standard testing document, this document proposes a formatting structure for a test script.
• 3.3 Good Documentation and Records Management
  The objective of this lesson is to give guidance on how to complete any written record, e.g. test script, batch sheet, training record, etc., to ensure the present and future integrity of that record.
• 3.4 Component Level Impact Assessment: Part-1 – Product Contact Components
  In order to begin determining the content of our testing verification (qualification) protocol, we need to establish which components have an impact on product quality and product safety. Here
  we begin by first taking a look at product-contact critical components.
• 3.5 Installation Test: P&ID Walk-Down
  The objective of this lesson is to describe a visual-installation test for equipment, instrumentation, piping and inline components in the form of a ‘P&ID Walkdown’.
• 3.6 Installation Test: Equipment Verification
  The objective of this lesson is to describe an installation test for equipment in terms of both visual and documentation checks.
• 3.7 Pumps
  In this lesson, we look at certain pumps used in the process industry and describe their operation.

• 4.1 Piping Components
  This lesson is an introduction to the various components that make up a complete section of the pipeline.
• 4.2 Relating P&IDs and Piping Isometrics
  This lesson describes piping isometric as a detailed design specification providing information for fabrication and installation of pipes.
• 4.3 Relating Piping Isometrics and 3D CAD Images
  In this lesson, we overlay the P&ID content and the isometric details onto the CAD (computer-aided design) design.
• 4.4 Material Traceability
  The objective of this lesson is to demonstrate how a mechanical contractor would keep a material record of all piping components during the fabrication and installation of a pipeline section.
• 4.5 Piping Tests
  The objective of this lesson is to describe a range of non-destructive testing (NDT) routinely conducted on newly installed piping.
• 4.6 Heat Exchangers
  This lesson is an introduction to heat exchangers where we use a thermal utility service to heat or cool a process fluid.
• 4.7 Instrumentation Symbols and Identification
  In this lesson, we are going to look at how most industries tag an instrument using alphabetical identifiers.
• 4.8 Installation Test: Piping Verification
  The objective of this lesson is to describe an installation test for piping in terms of both visual and documentation checks.

• 5.1 Process Control
  This lesson is an introduction to conventional process control using one-way digital and analog signals.
• 5.2 P&ID Instrumentation Identification
  In this lesson, we are again going to identify the instrumentation type on the P&ID but this time using the alphabetical identifiers.
• 5.3 Input-Output (I/O) List
  In this lesson, we are going to align the project Input-Output (I/O) list against the P&ID and identify signal types.
• 5.4 Process Control Hardware Panels
  In this lesson, we take a look inside a traditional process control cabinet and identify the various components within. We also look at digital and analog wiring diagrams.
• 5.5 Loop Signal Verification
  In this lesson, we learn how to ‘tune’ control loops, typically, during the commissioning phase of the project.
• 5.6 Installation Test: Instrument Verification
  The objective of this lesson is to describe an installation test for instrumentation in terms of both visual and documentation checks.
• 5.7 Proportional–Integral–Derivative Controller (PID controller)
  This lesson describes how a PID controller is used to adjust a dynamic process via a control element to maintain the desired process value.

• 6.1 Protocol Content – Part-3: Operational/Functional Testing
  This is our third lesson on the development of our testing verification (qualification) protocol where we consider operational/functional testing.
• 6.2 Component Level Impact Assessment: Part-2 – Operationally Critical Components
  Determining the content of our testing verification (qualification) protocol we also need to establish which functions have an impact on product quality and product safety. In this lesson, we establish those operationally critical components.
• 6.3 Operational Testing: Primary Functions
  The objective of this lesson is to determine the primary/critical functions of the ‘hot detergent’ and ‘hot PUW2 process water’ generation and distribution systems.
• 6.4 Testing Traceability Matrix for Equipment System –Second Pass
  In this lesson, we take our second look at the traceability matrix – a mechanism for tracing requirements through to the testing documents. At this stage we can add the details of our already established installation tests; and we now also use the matrix as a method to further plan and refine the necessary functional/operational tests.
• 6.5 Functional Design/Requirement Specification
  In this lesson, we look at the functional design/requirement specification that will describe the necessary automated functions needed to meet the desired user’s performance requirements.

• 7.1 Protocol Content – Part-4: Protocol General Attachments, and Deviation and Change Control Procedures
  This is our fourth and final lesson on the development of our testing verification (qualification) protocol where we introduce protocol general attachments, and deviation and change control procedures.
• 7.2 General Contents of a Validation (Master) Plan
  This lesson describes typical high-level corporate / site validation policy documents. It also describes the typical content and structure of a validation master plan (VMP), subordinate level validation plans, and validation reports to conclude the planning activities.
• 7.3 Protocol General Attachments
  This lesson describes the process for compiling and completing the protocol’s general attachments, and advises on how to making entries by hand into the protocol script?
• 7.4 Protocol Deviation Procedure
  This lesson describes how and where to use a verification protocol’s deviation procedure and associated deviation log.
• 7.5 Project Specific Change Control Procedure
  This lesson describes how and where to use a verification protocol’s change control procedure and associated change control log.
• 7.6 Protocol Template
  Ultimately, having studied in-depth both our process system and the content of protocols, we are now in a position to formulate a template for our very own verification/qualification protocol – that will incorporate both installation and functional/operational tests – to prove that our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’ is fit for its intended use.
• 7.7 Testing Traceability Matrix for Equipment System –Third Pass
  In this lesson, we take our third and final look at the traceability matrix – a mechanism for tracing requirements through to the testing documents. Having now formalized our protocol template we can now add the specific document-section details to the matrix for both our established installation and functional/operational tests.

• 8.1 Conclude List of Installation Tests
  The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required installation test procedures and GMP checksheets.
• 8.2 Conclude List of Functional Tests
  The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required functional test procedures and GMP checksheets.
• 8.3 Final Protocol Template Review
  The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required installation and functional tests and included all the necessary protocol attachments.

• Write an IQ OQ PQ protocol for a Clean-in-Place system.

You will become familiar with a range of documents used in projects including piping and instrumentation diagrams (P&ID), equipment specifications, instrument specifications, line lists, piping isometrics, 3D layouts, electrical and hardware control – panel diagrams, and wiring and loop diagrams. These design documents are used to generate IQ OQ PQ commissioning and qualification protocols.

You will also become familiar with:

• User Requirement Specifications (URS)
• cGMP impact-assessments
• cGMP design reviews
• Design Qualification (DQ) reports
• Specification and testing traceability matrices
• Typical testing IQ OQ PQ protocol templates

You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Technological University Dublin (Ireland) subject to the following criteria;

• Passing a written or oral Exam on the materials.
• The submission of all assessments and the end of module assignment.