Terminology and Abbreviations
This table includes some of the terms and abbreviations used regularly in the pharmaceutical water and sterilisation arenas. We have also included a number of internet links which will take you directly to the relevant website. If there are other terms you feel would help please let us know and we will include them in this list.
| AE (D) | Authorised Engineer Decontamination |
API |
Active Pharmaceutical Ingredient |
CCA |
Continuous Compliance Assurance |
Code of Federal Regulations |
|
cGMP |
Current Good Manufacturing Practice |
DQ |
Design Qualification |
Food and Drug Administration |
|
European Medicines Agency |
|
FMEA |
Failure Modes and Effects Analysis |
GAMP |
Good Automated Manufacturing Practice |
GMP |
Good Manufacturing Practice |
HACCP |
Hazard Analysis and Critical Control Points |
HTM |
Health Technical Memorandum |
International Conference on Harmonisation |
|
IQ |
Installation Qualification |
Irish Medicines Board |
|
| LAL | Limulus Amoebocyte Lysate |
MCA |
Medicines Control Agency |
Medicines and Healthcare products Regulatory Agency (formerly the MCA) |
|
OQ |
Operational Qualification |
Ph Eur |
European Pharmacopoeia |
PLC |
Programmable Logic Controller |
PQ |
Performance Qualification |
QA |
Quality Assurance |
QC |
Quality Control |
SOP |
Standard Operating Procedure |
TOC |
Total Organic Carbon |
URS |
User Requirements Specification |
USP |
United States Pharmacopoeia |
VMP |
Validation Master Plan |
WFI |
Water For Injections |
World Health Organisation |
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Keith
Shuttleworth & Associates Ltd
Unit D5 * Basepoint Business Centre * 110 Butterfield
Luton * LU2 8DL * United Kingdom
Tel: +44 (0)1582 433723 Fax: +44 (0)207 1173251
