Foundation Module Assignment

During this short foundation course you have touched upon a range of 25-topics across 5-major areas which have been chosen for their relevance to manufacturing safe and effective medicines and medical devices.

Your end-of-module assignment is to write a 2-3 page essay (700 to 1,000 words) to clearly demonstrate your Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment.

It needs to cover the following 5-areas (about ½ page on each):

• Session 1 – Quality Management Requirements for Good Manufacturing Practices (GMP)
• Session 2 – Process and Cleaning Validation
• Session 3 – Quality Risk Management (QRM)
• Session 4 – Key Manufacturing Technologies
• Session 5 – Clean Air & Purified Water Systems

Structure your essay by writing a short paragraph on any 2-topics from each of these 5-areas as detailed below:

Session 1 – Quality Management Requirements for Good Manufacturing Practices (GMP)

• The various ways drug products are administered.
• The importance of patient safety and product quality for medicines and medical devices.
• The key requirements of quality management system
• How to scientifically define product quality and the high-level principles of current good manufacturing practices (cGMP).
• The manufacturing’s responsibilities for (a) designing, developing, and documenting product and processes, (b) examining inputs, (c) performing and monitoring operations, and (d) addressing nonconformities.

Session 2 – Process and Cleaning Validation

• The definitions of ‘validation’, ‘commissioning’, ‘qualification’ and ‘verification
• The specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.
• The definition of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and the typical project design documents are required to prepare such testing protocols.
• The cleaning validation sequence and the basis for quantification limits and how to determine cleanliness levels on the basis of the analytical testing of representative samples.

Session 3 – Quality Risk Management(QRM)

• The importance of risk management and the basic steps involved in its application
• The risk management tool ‘Fault Tree Analysis’ and where and how we can use it.
• The main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and the important modes of (a) failure, (b) factors causing these failures, and (c) the likely effects of these failures.
• The management of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.

Session 4 – Key Manufacturing Technologies

• The typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis
• The biopharmaceutical manufacturing process and its 3-stage process sequences, i.e. Upstream Processing; Fermentation / Bio-reaction; Downstream Processing
• The critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
• The critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.

Session 5 – Clean Air & Purified Water Systems

• The generation, storage and distribution pharmacopeia grade purified water (PUW).
• The storage and distribution of pharmacopeia grade water for injection (WFI)
• The common cleanroom configuration and airflow direction, filter arrangements, cleanroom garments, and personnel and material flows
• The personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
• The airlock configurations typically used in combination safety under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have major impact on product quality and patient.
• The use of clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment