• 2-1 ISPE Baseline Guide 5 – Commissioning Practices
  In this lesson, we learn about the commissioning and qualification of manufacturing equipment systems in the pharmaceutical industries and about the importance of doing system impact and component impact assessments.
• 2-2 ISPE Baseline Guide 5 – Qualification Practices
  In this lesson, we look again at system and component impact assessment and specifically describe the qualification practices associated with direct impact systems that directly impact on product quality and patient safety.
• 2-3 ISPE Baseline Guide 5 – Enhanced Design Review (EDR) / (DQ)
  In this lesson, we learn how to do a documented review of the design of the overall process and facility systems for conformance to operational and regulatory expectations.
• 2-4 Cause and Effect – step 4 ‘Workshop’ exercise
  In this lesson, we learn about the risk management tool ‘Cause and Effect’ and see an example of where and
  how we can use it.
• 2-5: ISO 9001:2008
  This lesson is about the key requirements of quality management systems.
• 2-6: Good Engineering Practices (GEP)
  In this presentation, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
• 2-7: ASTM E 2500 – 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.

• 3-1: GAMP5 – Software Category
  This lesson, looks at the various GAMP categories of software and a ‘v-model’ approach to software projects? It also recommends a method on how to describe a critical computerized system to the regulatory authorities.
• 3-2: GAMP5 – Scalable Validation Deliverables
  In this lesson, the general content of a computerized validation plan and a summary report is described. Described also is the ‘system implementation lifecycle’ (SILC) and the ‘software development lifecycle’ (SDLC) with associated validation deliverables.
• 3-3: GAMP5 – Operation Activities
  This lesson describes the typical procedural activities associated with all commercial computerized systems in the operational stage of the lifecycle
• 3-4: 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.
• 3-5: GAMP5 – Risk-Based Decision Making
  This lesson explains how to apply risk-based decisions, making over the lifecycle of a computerized system: from the concept phase and through the project phase, into the operational phase and finally to the decommissioning stage.
• 3-5: 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).

• 4-1: Chemical Reactions
  In this lesson, we describe chemical reactions and list the substances involved, and explain what the rate-controlling steps are.
• 4-2: Separation Technologies
  In this lesson, we explain how to purify a dissolved compound from a mixture of substances using ‘liquid-liquid extraction’, ‘phase separations’ and ‘crystallization’.
• 4-3: 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.
• 4-4: Preliminary Hazard Analysis (PHA) – step 4 ‘Workshop’ exercise
  This lesson, explains when and how to do a Preliminary Hazard Analysis (PHA) study on a project to analyze hazards, and suggests how to document the process and who should conduct the study.
• 4-5: Multi-Stage Sequence API Synthesis
  In this lesson, we explore the typical sequence of deriving an API product using batch organic chemical synthesis and the types of facilities used
• 4-6: API Regulatory Guidelines
  In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
• 4-7: Relationship Between BPC and API
  In this lesson, we describe the similarities and differences between the terms ‘Active Pharmaceutical Ingredients’ (API) and ‘Bulk Pharmaceutical Chemicals’ (BPC), and we mention some typical material controls?

• 5-1: 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
• 5-2: Cellular Protein Synthesis
  This lesson explains the sequence of how a protein is created at a cellular level in terms of its contents and folded structure, and explains the template information necessary for its assembly process.
• 5-3: Hazard Operability Analysis (HAZOP) – step 4 ‘Workshop’ exercise
  In this lesson, we will watch a practical application of HAZOP that will identify process risk events that are caused by deviations from a system’s design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called “guide-words” (e.g., No, More, Other Than, Part of, etc.) and applying them to relevant parameters (e.g., contamination, temperature) to help identify potential deviations from normal use or design intentions.
• 5-4: Downstream Processing – Column Chromatography
  This lesson describes the basic principle behind the following column chromatography techniques:
  • Size Exclusion Chromatography (SEC).
  • ‘Ionic Exchange Chromatography (IEX).
  • Hydrophobic Interaction Chromatography (HIC).
  • ‘Affinity Chromatography
• 5-5: Biopharmaceuticals Manufacturing: Special Considerations
  This lesson looks at general considerations for a conventional biopharmaceutical process in terms of cell line preservation and viral barrier and viral clearance techniques.

• 6-1: Engineering Aspects of Cleaning, and Cleaning Equipment
  This lesson discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning.
• 6-2: Chemistry Aspects of Cleaning
  This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
• 6-3: Event Tree Analysis (ETA) – step 4 ‘Workshop’ exercise
  This lesson explores the application of Event tree analysis (ETA). Event tree analysis is an analysis technique for identifying and evaluating the sequence of events in a potential accident scenario following the occurrence of an initiating event. ETA utilizes a visual logic tree structure known as an event tree. The objective of ETA is to determine whether the initiating event will develop into a serious mishap or if the event is sufficiently controlled by the safety systems and procedures implemented in the system design.
• 6-4: Cleaning Validation
  This lesson 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.
• 6-5: 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.

• 7-1: Tablet Manufacturing
  In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
• 7-2: Vial Filling & Freeze Drying
  In this lesson, we will explore the critical process parameters and quality attributes associated with the filling of a medicinal vial and its subsequent freeze-drying.
• 7-3: FDA Medical Device Rules – CFR 820
  In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
• 7-4: Hazard Analysis and Critical Control Points (HACCP) – step 4 ‘Workshop’ exercise
  In this lesson, we are going to look at a full risk management process called Hazard Analysis and Critical
  Control Points (HACCP) and develop an understanding of the seven steps involved.
• 7-5: Medical Devices – EU Classification
  In this lesson, we look at how medical devices are classified in the European Union, and we explore the basis of the classification system.
• 7-6: 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.
• 7-7: 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.

• 8-1: 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.
• 8-2: 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.
• 8-3: Product Realization & Pharmaceutical Development
  In this lesson, we define the pharmaceutical product lifecycle in terms of development, technology transfer, commercial manufacturing and discontinuation.

Write a paper on “Why cGMPs are required for the manufacture of a life sciences product”. (in conjunction with writing skills training)

• 1.1 Design Documents Required for Generation of Installation and Functional Tests
  In this lesson, you will get an overall concept of the course. We will learn about the design of equipment, instrumentation, piping and control elements of a typical process system. We will also learn about the development of a testing verification protocol that we could present to the regulatory authorities demonstrating the system is fit for its intended use.
• 1.2 User Specification for a Reactor
  In this lesson, we will see the basic equipment configuration for a typical reactor system used for industrial chemical processing.
• 1.3 Equipment Configuration and Process Sequence for a Reactor
  In this lesson, we will go through a typical process sequence when using a reactor for chemical processing.
• 1.4 Generation of Piping and Instrumentation Diagrams (P&ID)
  In this lesson, we are going to look at a P&ID as a controlled document that is the basis of any process design. This is the first look we take at our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’. During the remainder of this course, we will extensively explore all design elements and generate an appropriate testing verification protocol.
• 1.5 URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
  We’ve already taken a first look take at our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’. Now we are going to examine the main equipment components and describe the major interconnectivity between them.
• 1.6 Equipment List
  In this lesson, we are going to align the project equipment list against the P&ID.
• 1.7 Instrument List
  In this lesson, we are going to align the project instrument list against the P&ID.
• 1.8 Inline Components List
  In this lesson, we are going to align the project inline component list against the P&ID.

• 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 cGMP Testing Principles
  This lesson considers high-level requirements when preparing a standard testing document.
• 2.4 Valves
  In this lesson, we take a look at valves as part of inline pipe fittings.
• 2.5 Piping (Line) List
  In this lesson, we are going to align the project piping (line) list against the P&ID.
• 2.6 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