Abbreviations, Acronyms and Terminology Used in the Pharmaceutical Industry Worldwide

 

Abbreviations, Acronyms and Terminology Used in the Pharmaceutical Industry Worldwide

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 Performance 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/ Loss on Drying
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
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
SP	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

 

Following are some of the most common excipients and their suggested use levels in pharmaceutical preparations.

 

Binders:

Polyvinylpyrrolidone (PVP) : 0.5-4%

Pregelatinized starch : 5-10% (wet), 5-20% (direct)

Starch paste : 5-25% w/w

Microcrystalline cellulose  : 5-25% (wet), 5-25% (direct)

Sucrose : 50-70% solution

Hydroxypropyl cellulose : 4-6%

Ethylcellulose : 5% solution

Methylcellulose : 1-6% solution (depending on viscosity grade)

Solvents:

Purified water

Ethanol

Purified water/ethanol

Other organic solvents (i.e Methnol + Isopropanol)

Fillers/Diluents:

Microcrystalline cellulose.

Lactose monohydrate and anhydrous.

Starch/pregelatinized starch

Di calcium phosphate (According to tablets/capsules size and weight)

Calcium carbonate

Compressible sugars

Mannitol

Sorbitol

 

Disintegrating Agents:

Sodium starch glycolate : 2-6%

Croscarmellose sodium : 1-6%

Pregelatinized starch : 5-10%

Starch : 5-10%

Microcrystalline cellulose : 5-15%

Crosspovidone : 2-5 %

Glidants/Lubricants/Antiadherents:

Fumed silicon dioxide (glidant) : 0.1-0.5% (anti-adherent) : 1-2%

Talc (anti-adherent) : 1-5%

Magnesium stearate : 0.25-2.0% .

Stearic acid : 0.5-3%

Hydrogenated vegetable oils : 2-5%

Sodium lauryl sulfate : 1-3%

Mineral oil : 1-3%

6. Others:

Dyes- Usually aluminum lakes: water soluble dyes precipitated with the hydrous oxide of aluminum.

Sweetening Agents & Flavors’- Compressible sugars/alcohols & various flavoring agents.

Wetting Agents- Sodium lauryl sulfate : 0.1-3%,

Polysorbate 80 : 0.1-3%

Acidifying Agents, Buffers, Stabilizers, etc….

Citric acid : 0.2-2%

Sodium citrate : 0.3-2 % (dihydrate).

Sodium phosphate (monobasic).