MHRA GMDP Symposium Abbreviations and Acronyms Quiz – Answers

J-GMP MHRA GMDP Symposium - Abbreviations and Acronyms Quiz

Here are the answers to our little quiz inspired by 8 hours of note-taking at the MHRA GMDP Symposium last week  – how did you get on?

Contact us for help with QA, QC, GMP, FDA, MHRA, ETC, ETC, ETC…

GMP – Good Manufacturing Practice. You knew that, right?     0

QRM – Quality Risk Management.    1

RA – Risk Assessment.    1

MHRA – Medicines and Healthcare products Regulatory Agency (why oh why isn’t it the MHPRA??).    1

HBEL – Health Based Exposure Limits     3

PDE – Permitted Daily Exposure. And Pennsylvania Department of Education. We’ll stick to Permitted Daily Exposure.    3

ATMP – Advanced Therapy Medicinal Products – not ‘something something manufacturing practice’…     3

DI – Data Integrity.    2

DIRA – Data Integrity Risk Assessment.    2

PIC/S – Pharmaceutical Inspection Co-operation Scheme. No, we don’t know why there’s a /.    2

CSV – Computer Systems Validation.    1

ICH – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. A gazillion extra marks if you got the whole thing.     3,000

CAPA – Corrective and Preventive Action.    1

GDP – Good Distribution Practice.    1

GLP – Good Laboratory Practice.    1

QP – Qualified Person.    1

RP – Responsible Person.    2

MRA – Mountain Rescue Association? Men’s Rights Activist? Myanmar Restaurant Association? No – Mutual Recognition Agreement. Obviously.    2

GAMP – Good Automated Manufacturing Practice.    2

HACCP – Hazard Analysis and Critical Control Points.    2

GPvP –Good Pharmacovigilence Practice.    3

ISO – International Organisation for Standardisation. So why isn’t it IOS?? The ISO thing isn’t wrong – it comes from the Greek ‘isos’ meaning ‘equal’.    3,000

IQ – Installation Qualification.    1

OQ – Operational Qualification.    1

PQ – Performance Qualification     1

PAT – Production Acceptance Test.    2

FAT – Factory Acceptance Test.    2

SAT – Site Acceptance Test.    1

DQ – Design Qualification.    1

MAH – Marketing Authorisation Holder.    2

FDA – Food and Drug Administration. Lose a mark if you said ‘Drugs’.    1

NICE – National Institute for Health and Care Excellence (minus point if you said Clinical – changed 2013).    2

PQS – Pharmaceutical Quality System.    1

SMF – Site Master File.     1

EMA – European Medicines Agency.    1

HEPA – High Efficiency Particulate Air.    2

VMP – Validation Master Plan.    2

QA – Quality Assurance.    1

QC – Quality Control.    1

CHMP –  Committee for Medicinal Products for Human Use (and patiently we say, why not CMPHU?).    3

CRO – Clinical Research Organisation.    2

CMO – Contract Manufacturing Organisation.    1

CDMO – Contract Developing and Manufacturing Organisation.    2

QRA – Quality Risk Assessment.    1

PQR – Product Quality Review.    1

FDS – Functional Design Specification.    2

 

You made it to the end!! You’re our kind of person. Join us on Twitter or LinkedIn, and look out for us next year at the MHRA GMDP Symposium.

 

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