| m |
Micron |
| (MCA) |
Medicines
Control Agency, now MHRA |
| ach |
Air changes
per hour |
| ACOL |
Acceptable
Carry-Over Limit |
| ADI |
Acceptable
Daily Intake |
| ADR |
European
Agreement on the Transport of Dangerous Goods by Road |
| AHU |
Air Handling
Unit |
| AIM |
Active
Ingredient Manufacturer |
| ANDA |
Abbreviated
New Drug Application (
USA) |
| AP |
Applicant’s
Part (of EDMF) |
| API(s) |
Active
Pharmaceutical Ingredient(s) |
| APIC |
Active Pharmaceutical Ingredients Committee
of CEFIC (website: http://apic.cefic.org) |
| APM |
Asset
Performance Management |
| APR |
Annual Product
Review |
| AR |
Annual Report |
| ASMF |
Active
Substances Master File (Europe) |
| BACPAC |
Bulk Actives
Post Approval Changes |
| Bioavailability |
A measure of
extent of drug absorption in the body |
| Bioequivalence |
A study to
demonstrate the equivalence of 2 medicines |
| BLA |
Biologies
Licence Application (FDA) |
| BP |
British
Pharmacopoeia |
| BPC |
Bulk
Pharmaceutical Chemical (
USA
) –
includes Actives and non-Active |
| BPE |
Bulk
Pharmaceutical Excipients |
| BMR |
Batch
Manufacturing Record |
| Bx |
Batch |
| C of A |
Certificate of
Analysis |
| CBE |
Changes Being
Effected (FDA) |
| CBER |
Centre for
Biologies Evaluation and Research (FDA) |
| CCP |
Critical
Control Point |
| CDER |
Centre for Drug
Evaluation and Research |
| CEP |
See C of S |
| CEFIC |
European
Federation of Chemical Industries – Conseil European des Federations de
l’Industrie Chimique |
| CFRs |
US Code of
Federal Regulations |
| CFU |
Colony Forming
Unit |
| cGMP |
current Good
Manufacturing Practices |
| CHMP |
Committee of
Human Medicinal Products – part of EMEA |
| CIP |
Clean in Place |
| CMC |
Chemistry,
Manufacturing and Control section of Registration Dossier |
| COMAH |
Control of
Major Accident Hazard Regulations |
| COP |
Clean Out of
Place |
| COSHH |
Control of
Substances Hazardous to Health |
| C of S |
Ph. Eur.
Certificate of Suitability |
| CPMP |
Committee of
Proprietary Medicinal Products now CHMP - part of EMEA |
| CPG |
Compliance
Policy Guide (FDA) |
| CPP |
Critical
Process Parameter |
| CQA |
Critical
Quality Attributes |
| CT |
Clinical Trial |
| CTD |
Common
Technical Document - Dossier for Products - ICH format |
| CVM |
Centre for
Veterinary Medicines (FDA) |
| CVMP |
Committee for
Veterinary Medicinal Products - part of EMEA |
| DI |
De-ionised
(Purified) water |
| DMF |
Drug Master
File |
| DOP |
Dispersed Oil
Particulates |
| DQ |
Design
Qualification |
| DR |
Deviation
Report |
| DS |
Drug Substance |
| DSM |
Drug Substance
Manufacturer |
| EAM |
Enterprise Asset
Management |
| EC |
European
Commission |
| ECM |
Enterprise Calibration Management |
| EDMF |
European Drug
Master File |
| EDQM |
European Directive
for the Quality of Medicines |
| EDR |
Enhanced
Design Review |
| EFD |
Engineering
Flow Diagram |
| EFPIA |
European
Federation of Pharmaceutical Industries Association |
| EINECS |
European
Inventory of Existing Commercial Chemical Substances |
| EIR |
Establishment
Inspection Report (FDA) |
| ELD |
Engineering
Line Diagram |
| ELINS |
European List
of Notified (New) Chemical Substances |
| EMEA |
European
Medicines Agency |
| EP |
See Ph.Eur |
| ER&S |
Electronic
Records and Signatures |
| ERA |
Environmental
Protection Agency |
| ERP |
Enterprise Resource Planning |
| EU |
Endotoxin Unit
or European Union |
| Eudralex |
Rules
Governing Medicinal Products in the European Union (European Drug Regulation
Lexicon) |
| EWG |
Expert Working
Group |
| FMEA |
Failure Modes
and Effects Analysis |
| FD and C Act |
US Federal
Food Drug and Cosmetics Act |
| FD-483 |
Official FDA
form for inspection observations |
| FDA |
Food and Drug
Administration |
| FIA |
Freedom of
Information Act (
USA) |
| FIFO |
First In First
Out |
| FS |
Functional
Specification |
| FS |
Federal
Standard (USA) engineering standards typically |
| g |
Gram |
| GAMP |
Good
Automation Manufacturing Practices |
| GC |
Gas
Chromatography |
| GCLP |
Good Control
Laboratories Practices |
| GCP |
Good Clinical
Practice |
| GEP |
Good
Engineering Practices |
| GHS (CPL) |
Globally Harmonised System of
Classification and Labelling of Chemicals (UN) |
| GLP |
Good
Laboratory Practice (applies to toxicology laboratories/studies) |
| GMP |
Good
Manufacturing Practice |
| GxP |
Good “x”
Practices = GMP, GAMP, GCLP, etc. |
| HACCP |
Hazard
Analysis, Critical Control Point |
| HAZOP |
Hazard and
Operating Studies |
| HEPA |
High
Efficiency Particulate Air filter |
| HPLC |
High Pressure
Liquid Chromatography |
| HR |
Human
Resources |
| HTM |
Health
Technical Memorandum |
| HVAC |
Heating
Ventilation and Air Conditioning |
| IATA |
International
Air Transport Association |
| ICAO |
International
Civil Aviation Organisation (UN) |
| ICH |
International
Conference on Harmonisation (
USA
,
EU,
Japan) |
| IMDG |
International
Maritime Dangerous Goods Code |
| IMO |
International
Maritime Organisation |
| IMP(s) |
Investigational
Medicinal Product(s) |
| IND |
Investigational
New Drug (
USA) |
| IPC |
In Process
Control |
| IPPC |
Integrated
Pollution Prevention and Control |
| IPEC |
International
Pharmaceutical Excipients Council |
| IQ |
Installation
Qualification |
| IQA |
Institute of
Quality Assurance (UK) (www.iqa.org) |
| ISO |
International
Standards Organisation |
| ISPE |
International
Society of Pharmaceutical Engineers (ww.ispe.org) |
| IT |
Information
Technology |
| JP |
Japanese
Pharmacopoeia |
| Kg |
Kilogram |
| LAF |
Laminar air
flow |
| LD50 |
Lethal Dose
where 50% of the animal population die |
| LOD |
Limit of
Detection |
| LOQ |
Limit of
Quantification |
| MA |
Manufacturing
Authorisation |
| MAA |
Marketing
Authorisation Application (Europe) |
| MACOL |
Maximum
Acceptable Carry Over Level |
| MDD |
Maximum Daily
Dose |
| Mfg |
Manufacturing |
| MHRA |
Medicines and
Healthcare products Regulatory Agency (UK) |
| Mkg |
Marketing |
| ML |
Manufacturer’s
Licence - UK Licence for Medicines Manufacturing sites |
| MRA |
Mutual
Recognition Agreement |
| MRO |
Maintenance
Repair and Operations |
| MRP |
Manufacturing
Resource Planning |
| MSDS |
Material
Safety Data Sheets |
| N/A |
Not Applicable |
| NASA |
National
Aeronautic and Space Agency (
U.S.A.
) |
| NC |
Non-clinical
(phase, studies) |
| NCE |
New Chemical
Entity |
| NDA |
New Drug
Application (
USA) |
| NF |
National
Formulary (
USA) |
| NLT or > |
Not Less Than |
| NMT or < |
Not More Than |
| NOAEL |
No Observable
Adverse Effect Level |
| NOEL |
No Observable
Effect Level |
| NONS |
Notification
of New Substances Regulations 1993 (EU) |
| OE |
Office of
Enforcement, FDA |
| OEL |
Occupational
Exposure Level |
| OHH |
Occupational
Health and Hygiene |
| OOS |
Out of
Specification |
| OQ |
Operational
Qualification |
| ORA |
Office of
Regulatory Affairs, FDA |
| ORO |
Office of
Regional Operations, FDA |
| OSHA |
Occupational
Safety and Health Administration (
USA
) |
| OTC |
Over the
counter medicine |
| P&ID |
Piping and
Instrument Drawing |
| PAD |
Pharmacological
Active Dose |
| PAI |
Pre Approval
Inspection |
| PAR |
Proven
Acceptable Range |
| PAS |
Prior Approval
Supplement (FDA) |
| PAT |
Process
Analytical Technology |
| PDA |
Parenteral
Drug Association (
USA) |
| PDE |
Permitted
Daily Exposure |
| PFD |
Process Flow
Diagram/Drawing |
| Ph. Eur. |
European
Pharmacopoeia |
| PHA (HazAn) |
Process Hazard
Analysis |
| PhARMA |
Pharmaceutical
Association of Research-based Manufacturers (PMA,
USA
) |
| Pharmacokinetics |
The study of
the rate of adsorption of medicines in the body |
| P-I, P-II,
P-III |
Phase I, Phase
II, Phase III (in Clinical Trials) |
| PIC/S |
Pharmaceutical
Inspection Convention/Cooperation Scheme |
| PL |
Product
Licence -
UK Marketing Authorisation (Dossier) |
| PLC |
Programme
Logic Controller |
| PMA |
Pharmaceutical
Manufacturers Association |
| POM |
Prescription
Only Medicine |
| ppb |
Parts per
Billion |
| PPE |
Personal
Protective Equipment |
| ppm |
Parts per
Million |
| PPM |
Planned
Preventative Maintenance |
| PPQ |
Process
Performance Qualification |
| PQ |
Performance
Qualification or Process Qualification |
| PQG |
Pharmaceutical
Quality Group (www.pqg.org) |
| PQR |
Product
Quality Review |
| PS or P/S |
Particle Size |
| PTFE |
Polytetrafluroethylene |
| PV |
Process
Validation |
| QA |
Quality
Assurance |
| QC |
Quality
Control |
| QOS |
Quality
Overall Summary (of CTD) |
| QP |
Qualified
Person |
| QSIT |
Quality
Systems Inspection Technique |
| QU |
Quality Unit |
| QWP |
Quality
Working Party |
| R&D |
Research and
Development |
| RD |
Registration
Dossier |
| RH |
Relative
Humidity |
| RO |
Reverse
Osmosis |
| RM |
Raw Material |
| RP |
Restricted
Part (of EDMF) |
| RSM |
Registered
Starting Material |
| SHE (or HSE) |
Safety, Health
and Environment |
| SM |
Starting
Material |
| SMF |
Site Master
File |
| SOP |
Standards
Operating Procedure |
| SPC |
Summary of
Product Characteristics |
| SPC |
Statistical
Process Control |
| SUPAC |
Scale-up, Post
Approval Changes (FDA) |
| TAVC |
Total Aerobic
Viable Count |
| TDI |
Tolerable
Daily Intake |
| TGA |
Therapeutic
Goods Agency (
Australia) |
| TLC |
Thin Layer
Chromatography |
| TNTC |
Too Numerous
To Count |
| TOC |
Total Organic
Carbon |
| TSCA |
Toxic
Substances Control Act 1976 (
USA
) |
| TSE |
Transmissible
Spongiform Encephalopathies (BSE) |
| TT |
Technology
Transfer |
| TTR |
Technology
Transfer Reports |
| TVC |
Total Viable
Counts |
| U |
Units |
| ULPA |
Ultra Low
Particulate Air Filter |
| URS |
User
Requirement Specification |
| USP |
United States Pharmacopoeia |
| UV |
Ultra Violet |
| VMP |
Validation
Master Plan |
| VOC |
Volatile
Organic Compound |
| VSR |
Validation
Summary Report |
| WFI |
Water for
Injection |
| WHO |
World Health
Organisation |
