Example programme structure
This course is designed primarily for those working within the pharmaceutical industry who wish to develop their careers through a distance learning course. It will give students an all-round education in the manufacture of pharmaceutical products. It is particularly relevant to professionals who are seeking a more detailed understanding of the issues involved in setting up and running large scale plant for the manufacture of drugs and other pharmaceuticals.
The four units can taken either as assessed or un-assessed CPD.
- Unit 1: The Pharmaceutical Industry
- Unit 2: Pharmaceutical Processes
- Unit 3: Pharmaceutical Quality
- Unit 4: Facilities – design construction, operation and maintenance.
This unit gives a general summary of the way the pharmaceutical industry is shaped and the major driving forces that make the manufacture and commercialisation of pharmaceuticals different from the manufacture of other chemical products.
Industry overview
Size, shape, diversity and cost drivers.
Why is this industry different
The issue of patient safety.
The regulatory environment
Marketing authorisations, license to manufacture and an introduction to good manufacturing practice.
Cross contamination during manufacture
Common contaminants, process/quality control. Product packaging and labelling.
An introduction to process validation
Bio-burden, sterilisation and viral removal
Methods of sterilisation and cleaning. Solids handling and related issues.
An introduction to project management
Developing the new drug from the semi-technical scale to full scale manufacture. Issues with new formulations and the installation of new equipment with its associated testing and documentation.
The business environment
- A description of the product life cycle from initiation to final sales.
- Important issues such as speed to market and cost with illustrations from the development of Zantac. Packaging and product types.
The processes for making pharmaceutical products make radically different demands on the chemist (or biochemist) and engineer. It affects in detail the whole design of the plant, how it operates, the control processes within the plant and way the final product is stored and dispatched. This unit describes in detail those differences and its effect on plant economics.
Development of user requirements
Develop users requirements that suit both parties.
Process design and optimisation
The most effective methods of optimising production from new plant.
Process equipment selection and sizing
Strategies for selecting the best and most economical equipment and the most effective process technology. The importance of safety considerations, avoiding cross contamination.
Utility sizing and design concepts
Sizing for clean services, black process services and building services.
Facility sizing and functionality
Factors controlling the size of buildings.
Process control and automation
Choice of instrumentation. Use of computer control. SCADA systems. Electronic records and a variety of related issues.
Technology foresight
Lean manufacturing and continuous process.
SHE specific to pharmaceuticals
Occupational hygiene and operator protection.
Commissioning and equipment qualification
- An overview of the whole process. Starting materials.
- Manufacture of chemically derived APIs. Formulation and manufacture of bulk dosage forms. Filling and packaging.
- Finished products warehouse and dispatch.
- Industrial scale biologically directive active ingredients.
This unit captures the principles of the complex quality and regulatory framework within which the Pharmaceutical industry works, explains the differences in approach to quality and regulation throughout the world and considers the consequences for successful management of pharmaceutical projects.
Introduction and overview
- Definition and meaning of quality.
- Quality control quality assurance and good manufacturing practice.
- Principles as laid down by the EEC. Management of quality.
- Personnel premises and equipment. Document, production and quality control. Product recall.
Personnel and training
Management and organisation, skills training, motivation, personal hygiene.
Documentation
Its importance, control and revision of documents , retention of records, types of documentation essential to the manufacturing process.
Contamination
Different type of contamination, people as a source, contamination control.
Premises and equipment
Structures and finishes, basic design and layout equipment.
Plant services, systems and utilities
- HVAC, Lighting, water in the various forms required (potable etc.), water treatment and supply, steam, gasses, electricity solvents and other bulk liquids.
- Quality requirements for sterile products and other specific manufacturing operations.
- Sterile products, methods of sterilisation, sterile filtration, sterilisation equipment.
- Clean rooms, the sterile products suite, room standards, air supplies.
- The sterile manufacturing environment, other types of manufacture (solids creams etc). Packaging , storage.
Validation and qualification
Validation of equipment cleaning procedures, validation in the EU.
Calibration, statistical quality control, parametric release and quality auditing
Terminology of calibration, statistical process control, parametric release, self inspection, the quality auditor. Inspection check lists.
Quality design and total quality management
- Quality aspects of R and D and scale-up. Clinical trials and GMP.
- Distribution, wholesaling and beyond, good distribution practices for medical products. ISO 9000 and related standards.
Regulatory aspects
- Thalidomide, the UK Medicines act (1968). The Medicines Inspectorate.
- GMP in the UK and the EU. Relevant legislation. The Pharmaceutical Inspection Convention Scheme. GMP guidelines and their relationship to all aspects of production and distribution. The United States' system.
This unit describes how the functional requirements described in unit 2 can be married with the regulatory requirements described in unit 3 via the selection of the proper equipment and the appropriate design, construction operation and maintenance of the manufacturing facility. Issues of sustainability and the reduction of carbon emissions will be discussed in detail.
Specific characteristics of the pharmaceutical manufacturing facility
- Differences from other chemicals manufacturing plant.
- Protecting product quality. Specific Environmental issues.
- Overall consequences for the design.
- Protection of manufactured product, material and personnel flow though the facility, future upgrading and expansion.
The effect of product type on plant design
- Solids, liquids, parentals, biopharmaceuticals.
- Warehousing and other services.
- Basic methods of construction.
Containment, isolation and HVAC
- Understanding the need. Standards and legislation.
- Clean rooms. Barrier technology. Ways of working, HVAC systems.
Construction materials, fixtures and finishing
- Typical methods of construction – an overview. Crack free and crevice construction.
- Materials selection.
- Cost comparisons. Avoidance of over-specification.
Water and utilities
- Water supply.
- Grades and use of water.
- Water economy.
- Steam, gasses and compressed air.
Energy and carbon dioxide emissions
- Overviews of the energy loss from the building envelope and from the production processes. Conflicts (e.g. between ventilation and clean room requirements. The regulatory framework. Compliance issues.
- A global perspective. Ways of reducing energy consumption and carbon dioxide emissions. Cost implications. The future.