Foundation End-of-Module Assignment: Understanding Quality Culture in GMP Manufacturing

1. Describe the various ways drug products are administered.
2. Give an overview of the importance of patient safety and product quality for medicines and medical devices.
3. List the key requirements of quality management system
4. Describe how to scientifically define product quality and the high-level principles of current good manufacturing practices (cGMP).
5. Give an overview of the manufacturing’s responsibilities for:
   1. designing, developing, and documenting product and processes,
   2. examining inputs,
   3. performing and monitoring operations, and
   4. addressing nonconformities.

2) Process and Cleaning Validation

1. Define the terms – ‘validation’, ‘commissioning’, ‘qualification’ and ‘verification’
2. Give an overview of the specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.
3. Define installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and the typical project design documents are required to prepare such testing protocols.
4. Describe 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.

3) Quality Risk Management (QRM)

1. Describe the importance of risk management and the basic steps involved in its application
2. Give an overview of the risk management tool ‘Fault Tree Analysis’ and where and how we can use it.
3. Detail the main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and the important modes of:
   1. failure,
   2. factors causing these failures, and
   3. the likely effects of these failures.
4. Describe the management of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.

4) Key Manufacturing Technologies

1. Detail the typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis
2. Describe the biopharmaceutical manufacturing process and its 3-stage process sequences, i.e. Upstream Processing; Fermentation / Bio-reaction; Downstream Processing
3. Give an overview of the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
4. Give an overview of the critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.
5. Describe the generation, storage and distribution pharmacopeia grade purified water (PUW).
6. Describe the storage and distribution of pharmacopeia grade water for injection (WFI)
7. Give an overview of the common cleanroom configuration and airflow direction, filter arrangements, cleanroom garments, and personnel and material flows
8. Detail the personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
9. Give an overview of 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.
10. Describe how the use of clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment