Lecture 1

Question 1

What is the definition of Quality Management (QMS)?

Answer 1

Quality Management is the coordinated activities required to direct and control an organization with regard to quality, aiming to guarantee the quality of a product throughout its life.

Question 2

Why is QMS required by the pharma/biopharma/medical device industries?

Answer 2

These companies are legally required to follow quality standards to ensure the safety and efficacy of their products, as they are heavily regulated.

Question 3

Give examples of typical products for the following industries: (a) Medical device
(b) Pharmaceutical
(c) Biopharmaceutical
(d) Service providers

Answer 3

(a) Contact lenses, stents
(b) Tablets, solutions
(c) Biological/therapeutic proteins (e.g., enzymes, hormones, mABs)
(d) Raw materials, contract lab testing, logistics, transport

Question 4

How can a safe product be ensured?

Answer 4

A safe product doesn’t cause harm to the patient or administrator and shouldn’t interfere with the treatment, prevention, or diagnosis of a disease.

Question 5

List examples of tools used in Quality Management Systems (QMS).

Answer 5

Flowcharts, Failure Mode and Effects Analysis, staff training, preventive maintenance, quality control test procedures.

Question 6

Where can we encounter Quality Management?

Answer 6

Production plant, laboratory, procurement office, accounts, receiving and shipping stores, human resources department.

Question 7

What is continuous improvement in the context of QMS?

Answer 7

a recurring activity that increases the ability to meet requirements, ensuring the final product meets the required standards.

Question 8

Identify QMS standards typically used by the pharma/biopharma/medical device industries.

Answer 8

ISO 9000
ISO 14000
ISO 17025
ISO 45001

Question 9

Who or what are the following: Shewhart, Deming, BSI, ISO, ISO 9000, ISO 17025, ISO 14000, ISO 45001?

Answer 9

a) Shewhart: Developed methods for statistical analysis and control of quality in the 1930s.
(b) Deming: Taught quality control methods to Japanese engineers, origin of Total Quality Management (TQM).
(c) BSI: British Standards Institution, part of the evolution of QMS standards.
(d) ISO: International Organization for Standardization, sets global standards for reliability and effectiveness.
(e) ISO 9000: Series of quality management system standards.
(f) ISO 17025: Standard for calibration and testing labs.
(g) ISO 14000: Standards for environmental management.
(h) ISO 45001: International Health and Safety Management Certification.