quality assurance and british pharmacopiea

What is quality assurance (QA)?


Systematic process ensuring products, services and processes consistently meet defined quality requirements

What does QA provide across an organisation’s operations?


Structured framework embedding quality from planning and production to testing, packaging and delivery

What is quality control (QC)?


Checking outputs to verify they meet specified requirements

What are two key characteristics of QC?


Output-oriented and detective

. What is GMP?


Minimum standard medicines manufacturers must meet in production processes

What requirements must products meet under GMP?


Consistent high quality, appropriate intended use, and marketing authorisation/product specification requirements

Why are QA, QC and GMP important in pharmaceutical manufacture?


Product quality and consistency,

regulatory compliance,

prevention of errors,

protection from contamination,

maintaining efficacy,

patient/professional confidence and patient safety

Is dissolution testing QA or QC


QC

Is staff training QA or QC?
.

QA

Is equipment calibration QA or QC?


QA

Is testing raw materials QA or QC?


QC

Is SOP development QA or QC?


QA

Is batch release testing QA or QC?


QC

At what points is quality testing performed during manufacture?


Multiple points throughout manufacture

What stages of manufacture are commonly tested?


Raw material testing, in-process controls and finished product testing

Why are medicine alerts, recalls and safety information sometimes needed despite rigorous controls?


Defective medicines may be released to the public

Who should defective medicines be reported to?


MHRA

What actions may be taken following reports of defective medicines?


Alerts, recalls or additional safety information

What is the British Pharmacopoeia (BP)?


UK reference source for medicine quality control

Who publishes the BP and under what legislation?


BP Commission (part of MHRA) under the Medicines Act 1968

. What do BP monographs contain?


Quality standards, tests, specifications and analytical methods

What did the BP previously contain more of?


Working formulae

What do BP general notices and appendices provide?


Definitions of expressions and detailed testing information

Which pharmacopoeia has legal status in the UK?


European Pharmacopoeia

Why is the BP still relevant?


Ensuring medicine quality,

understanding specials/extemporaneous preparations,

investigating quality concerns,

supporting procurement/formulary decisions

, understanding generic interchangeability and the UK regulatory landscape

What is Martindale?



Complete drug reference

Where can Martindale be accessed?


Medicines Complete

What information does Martindale provide?


Nomenclature, physical/pharmaceutical properties, adverse effects and uses of drugs/excipients

What is Pharmaceutical Excipients?


Reference source for inactive compounds in medicines.

. Where can Pharmaceutical Excipients be accessed?


Medicines Complete

What information does Pharmaceutical Excipients provide?


Uses, physical and chemical properties, safety and handling

What do incompatibilities affect?


How a medicinal product is formulated and stored

What is Article 65 guidance?


Guidance listing excipients that may affect patients

Which excipients must be listed under Article 65 guidance?


Excipients that can have an effect on the patient

Where must Article 65 excipients be listed?


Medicine label

Are Article 65 excipients listed on dispensing labels?


No.

Where can concentrations of flavourings and preservatives be found?


Pharmaceutical Codex 1994

In which dosage forms are flavourings and preservatives commonly used?


Liquid dosage forms

What must formulators know about flavourings and preservatives?


Appropriate concentrations plus advantages and disadvantages

Why is medicine quality essential?


Patient safety

What is the role of QA?


Prevent defects

What is the role of QC?


Detect defects

What does the BP provide for medicines in the UK?


Legally recognised quality standards

What do modern BP monographs define?


Standards rather than manufacturing recipes

What professional responsibility do pharmacists have regarding medicine quality?


Understand and apply quality standards throughout medicines use and use reference sources such as BP, Pharmaceutical Codex, Martindale and Article 65 guidance where appropriate