• 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 Manufacturing Logistics Calculations
  In this lesson, we learn how to determine the size and capacity of primary processing equipment based on patient dosage requirements and the number of potential patients.
• 1.2 Process Flow Diagram (PFD) 
• 1.3 Controlling Air Quality In this lesson, we take our first look at an air handling unit (AHU) and describe its functions.
• 1.4 Heating, Ventilation, and Air Conditioning (HVAC) Systems In this lesson, we take a look at an overall heating and ventilation control (HVAC) system and explain its primary attributes.
• 1.5 Basic Biopharmaceutical Unit Operations
  1-5-1 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug substance manufacturing operation.
  1-5-2 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug product formulation/fill-finish and packaging/labelling manufacturing operation.
• 1.6 Pharmacopeia Grade Waters
• 1.7 Process Support and Utilities
  In this lesson, we take a look at the clean utilities requirements for a biopharmaceutical drug substance manufacturing process.

• 2.1 Introduction to ISO 9001:2008 and 2015
  This lesson is about the key requirements of a quality management system.
• 2.2 Typical GMP list for drug substance
  This lesson explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
• 2.3 Operational Activities
  In this lesson, we take a look at how to maintain a critical computerized system in a state of operational control using standard procedures.
• 2.4 GMP for Personnel
• 2.5 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.
• 2.6 Maintenance: Good and Best Practices
  In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.

• 3.1 Project Lifecycle for New and Modified Facilities
  In this lesson, we describe the typical phases of a project lifecycle: conceptual design, tender contract analysis, basic engineering, detailed design, and project realization.
• 3.2 Plant Layout
  In this lesson, we explore the vertical distribution of process equipment for a bulk process building, the horizontal layout for a bulk process building, and an entire site layout for an integrated biopharmaceutical manufacturing site.
• 3.3 Zoned Air-Conditioning Systems
  In this lesson, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space).
• 3.4 Isolator Technology
  In this lesson, we explain the principles behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation.
• 3.5 Cell Breakage
  In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.

• 4.1 Purified Water (PUW) Generation, Storage and Distribution
  In these lessons, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
• 4.2 Clean Room and Clean Air Device monitoring 
• 4.3 Good Engineering Practices Procedures
  In this lesson, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
• 4.4 GMPs for Buildings and Facilities 
• 4.5 Quality Systems Approach to cGMP Regulations – Management Responsibilities
  In this lesson, we outline management’s role in the design, implementation, and management of the quality system.
• 4.6 Maintenance Program
  In this lesson, we describe the key aspects of a typical maintenance program.

• 5.1 Conceptual Design – Part-1
  In this lesson, we begin to explore a quantified effort in how to size, shape, program, and cost an investment.
• 5.2 HVAC Requirements for Non-Sterile API Manufacturing
  In this lesson, we look at how to use airflow direction as a means of a containment barrier between operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
• 5.3 Plant Automation
  This lesson is an introduction to conventional process control using one-way digital and analogue signals.
• 5.4 Plant Steam
  In this lesson, we describe a process for generating and distributing plant steam to various processes within a manufacturing facility, and also describe how to manage any resultant condensate.
• 5.5 Clean Steam Generators
  The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation. 
• 5.6 Steam Sterilization in Place
  In these lessons, we look at the mechanism behind sterilization of process equipment using saturated steam.
• 5.7 GMPs for Process Equipment 
• 5.8 Quality Systems – Resources
  In this lesson, we describe what resources need to be allocated for a quality system and operational activities.

• 6.1 Conceptual Design – Part-2
  This lesson describes what influences the layout of a facility in terms of: Layers, Preliminary Layout, Process Layouts, Media and Buffer Preparation, Clean Utilities and CIP, Access Corridors, Warehouse / Material Movements, Personnel Movements, Decisions on Height, Air Handling, General Utilities, Electrical, Controls & Automation, Finishes, Structural / Civil, Cost Estimate, and Schedule.
• 6.2 Air Flow Patterns 
  In these lessons, we look at laminar air-flow patterns in the context of filling open vessels aseptically, and at the configuration and operation of both a laminar flow booth and a laminar flow cabinet typically found in the biopharmaceutical industry.
• 6.3 Cleanroom Layout 
  In this lesson, we take a high-level look at a common cleanroom configuration and discuss items such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals. 
• 6.4 Filter Ratings
  In these lessons, we look at the particle retention efficiencies of air filters of various grades rated in accordance with European normalisation standards EN779 and EN1822. We also look at the particle arrestance efficiency of air filters of various grades rated in accordance with the ASHRAE standard 52-2 ‘Minimum Efficiency Reporting Value (MERV Rating)’.
• 6.5 Logic Gates Functions and PLC 
• 6.6 WFI Storage and Distribution
  In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification.
• 6.7 Good Engineering Practices Procedures
• 6.8 Quality systems Approach- Manufacturing
  In this lesson we describe Manufacturing’s responsibilities for (a) designing, developing, and documenting product and processes, (b) examining inputs, (c) performing and monitoring operations, and (d) addressing nonconformities.
• 6.9 Maintenance- Work Executions
  In this lesson we describe the following Maintenance tasks and activities: (a) work request, (b) work order management, (c) information requirements for work orders, and (d) performance measurement.

• 7.1 Site Master Planning – Part-I
  In this lesson, we take our first look at site master planning based on: planning rationale, assumptions, prerequisites, typical bulk production unit, site scope, flexibility, expandability, & future-proofing, determining size requirements, sizing & shaping, and broad rules.
• 7.2 Classification of Clean Areas – Vial Filling 
  In these lessons, we look at: (1) how to classify areas for aseptic operations, (2) typical configurations of air handling units (AHU’s), terminal filters, zone air-inlets and -exhausts to support various classified environments, (3) filter arrangements in air handling units and in their supply air ducting, (4) particles limits associated with various classified air environments, and (5) viable microbial limits, measured as Colony Forming Units (CFU), associated with various classified air environments.
• 7.3 Area Classification Protection
  In this lesson, we observe a range of airlock configurations typically used in combination under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient. 
• 7.4 Compress Air and Pneumatics 
• 7.5 Aseptic Filling
  In this lesson, we describe the process equipment for the filling of medicinal vials aseptically in the sequence of: washing, dehydrogenation, filling and their subsequent inspection.
• 7.6 Cleanroom Gowning
  In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment.
• 7.7 Aseptic Processing 
  In these lessons, we look at various manual and automated processes and facility layouts for vial filling operations.
• 7.8 Cleanroom Monitoring – Physical Tests
  In this lesson, we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.
• 7.9 Quality System – Evaluation Activities 
• 7.10 Maintenance Management
  This lesson describes the processes and controls used in the delivery of maintenance services and work execution.

• 8.1 Site Master Planning – Part-II
  We continue in this lesson exploring the configuration philosophy for a site specifically layering configuration options, fermentation/bioreactor, media and buffer preparation. We also look at the shaping and sizing options for fermentation, media preparation, buffer preparation, downstream processing, process and general utilities, buildings, and expansion.
• 8.2 Open Versus Closed Processing  
• 8.3 Facility Layout Concept 
• 8.4 Blow/Fill/Seal Technology 
• 8.5 PLC Programming
  In this lesson, we describe how to program a PLC to automate a machine using ladder logic diagrams.
• 8.6 PLC Program Case Studies 
• 8.7 Cleanroom Monitoring – Microbiological Tests
  In this lesson, we look at a range of typical microbiological measurements to monitor a cleanroom environment for conformance to specifications.
• 8.8 Cleanroom Monitoring – Cleanrooms Cleaning Procedures 
• 8.9 Terminally Sterilised Products 
• 8.10 EU Guidelines on Cleanroom Aseptic Preparation 

• 9.1 HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing 
• 9.2 Batch Process Control
  In this lesson, we discuss the ISA-88.01 modularization software standard for segmenting a process into physical entities, and into procedural models for instructional recipes. The physical model is used to describe equipment, and the procedural model used to describe recipes (process sequencing).
• 9.3 Nitrogen Supply and Distribution
• 9.4 Environmental Monitoring Program 
  In this lesson, we describe how to monitor a cleanroom environment in order to identify actual and potential sources of contamination using both physical and microbiological techniques.
• 9.5 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.
• 9.6 FDA Guidance on Aseptic Processing 

• 10.1 Construction Lifecycle
  In the first lesson for construction lifecycle, we explore the following: choosing a construction type, substructure, options for super-structure, internal building fabric, mechanical installation, electrical & instrumentation, construction sequence for new build, constructability, construction management, construction safety, construction costs, schedule, and quality management. In the second lesson, we look at the contents of clean utility piping test packs. In the third lesson, we look at modular construction and sustainable construction.
• 10.2 Software Functional Block Diagram (FBD)
• 10.3 ASTM E 2500
  In this lesson, we review the ASTM International standard E 2500 – 07 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’.

Title of Assignment. – Site master plan for a new aseptic manufacturing facility, and the design of its environmental control and clean utility systems.

Write a 3,000-word report to give senior management the information they need to make informed decisions about a new aseptic manufacturing facility. The report should cover the 5 key sections of:

1. Production Logistics
2. Process Flow
3. Site Master Plan
4. Cleanroom Layout
5. Utility Support Systems

• Topic 1: Starter Pack
• Topic 2: Get to Know the Industry
• Topic 3: Analysing Job Adverts
• Topic 4: Skills Assessment
• Topic 5: Your Personal Pitch

• Topic 1: CV Writing 1
• Topic 2: CV Writing 2
• Topic 3: Tailoring Your CV
• Topic 4: Cover Letters
• Topic 5: Speculative Applications

• Topic 1: Network Mapping and Growing Your Network
• Topic 2: Online Networking
• Topic 3: Interviews
• Topic 4: Interview and Psychometric Testing Practice

•  Assignment