Pharmaceutical Quality Systems

Question 1

What is quality management system (QMS)?

Answer 1

A structured system that documents processes, procedures and responsibilities for continuously delivering high-quality products and services that meet regulatory and customer requirements
AIM - provide a framework
Ensure products are consistently produced to the required standard

Question 2

Name the 3 concepts that an effective QMS must include

Answer 2

Good Manufacturing Practice (GMP)
Quality Control (QC)
Quality Assurance (QA)

Question 3

Define good manufacturing practice (GMP)

Answer 3

Is the minimum standard that a medicines manufacturer must meet in their production processes

Products must:
- be of consistent high quality
- be appropriate to their intended use
- meet the requirements of the MA or product specification

Question 4

What regulatory body carries out inspections to check if manufacturers comply with GMP?

Answer 4

MHRA
product inspections - EMA

Question 5

Who is responsible for GMP?

Answer 5

Responsible/ Accountable Pharmacist

Question 6

What is quality assurance (QA)?

Answer 6

Is a systematic approach aimed at ensuring the quality of the product throughout its lifecycle
AIM - prevent mistakes and defects and manage quality through defining processes, establishing standards and developing guidelines
Focuses on defect prevention, aiming to reduce errors in the final product by identifying and mitigating potential risks early in the process

Question 7

How do we design an effective PQS?

Answer 7

Must reflect the regulatory requirements
In the pharmaceutical industry, some of the important quality standards and guidelines are ISO 9001:2015 and ICH Q10

Question 8

What does the ‘orange guide’ cover?

Answer 8

Wide ranging concept, which covers all matters which individually or collectively influence the quality of a product
Both the Orange Guide and ICH Q10 - a risk based approach which should be implemented throughout a products life style