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.
