Friday, August 18, 2017
Wednesday, August 16, 2017
Walk in Panacea biotech, baddi at 17 Aug & 18th Aug 2017
Walk in for panacea biotech for production and packing department at Baddi, Himachal Pradesh on 17th Aug 2017 and 18th Aug 2017
Tuesday, August 15, 2017
Disintegration Time for tablets as per IP, BP and USP
Disintegration Time:-
Uncoated Tablet
NMT 15 min, in water with Disc 370C ± 20C
Coated Tablet
NMT 30 min, In water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated tablet
Enteric Coated Tab
Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. According to USP 2 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid.
Dispersible/Soluble
Within 3 min in water at 250C ± 10C (IP) & 15 – 250C (BP)
Orodispersible
Within 1 min
Effervescent Tab
5 min in 250 ml water at 20 – 300C (IP) & 5 min in 200 ml water at 15-250C (BP)
Buccal & Sublingual
Not Applicable but dissolve within 15 – 30 min.
Uncoated Tablet
NMT 15 min, in water with Disc 370C ± 20C
Coated Tablet
NMT 30 min, In water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated tablet
Enteric Coated Tab
Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. According to USP 2 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid.
Dispersible/Soluble
Within 3 min in water at 250C ± 10C (IP) & 15 – 250C (BP)
Orodispersible
Within 1 min
Effervescent Tab
5 min in 250 ml water at 20 – 300C (IP) & 5 min in 200 ml water at 15-250C (BP)
Buccal & Sublingual
Not Applicable but dissolve within 15 – 30 min.
DT Apparatus:- Mesh Apperture:- 2mm (#10), Cycles:- 28 – 32 cycles/min, 50 – 60 mm distance from bottom & top, Temp of water 370C ± 20C. If 1 or 2 tabs fail, repeat for 12 tabs.
Weight variation limit for tablet and capsule.
Weight Variation Limits:-
1) For Tablets
IP/BP. Limit. USP
80 mg or less. 10% 130mg or less
80 mg to 250mg. 7.5% 130mg to 324mg
250mg or more. 5% More than 324mg
2) For Capsule:-
IP
Limit
Less than 300mg
10%
300mg or More
7.5%
IP
Limit
Less than 300mg
10%
300mg or More
7.5%
Saturday, August 5, 2017
ABBREVIATION USED IN PHARMACEUTICALS
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ABBREVIATION: Abbreviation
is an shortened form of an word, the most commonly used abbreviations in pharmaceutical company
AADA:
Abbreviated antibiotic drug application
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ADE:
Adverse drug event
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ADME:
Absorption, distribution, metabolism, and excretion
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AHU: Air
Handling Unit
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ANDA:
Abbreviated new drug application
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ANVISA: Agência
Nacional de Vigilância Sanitária (National Health Surveillance
Agency Brazil)
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AP:
Applicants Part (of EDMF)
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API:
Active pharmaceutical ingredient
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APR:
Annual product review (APQR – Annual product quality
review)
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AQL:
Acceptable quality level
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AR:
Analytical Reagent
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ASHRAE:
American Society of heating, Refrgeration and
Air
Conditioning Engineers
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ASM:
Active Substance Manufacturer
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ASMF:
Active Substance Master File
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AST:
Accelerated stability testing
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ASTM: American
Society for Testing and Materials
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BA/BE:
Bioavailability/bioequivalence
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BCS:
Biopharmaceutical classification system
BDR: Batch
Distribution Record
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BET:
Bacterial Endotoxin Test
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BFS:
Blow Fill Seal
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BI: Biological
Indicator
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BMR: Batch
Manufacturing/Processing Record
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BOD:
Biological Oxygen Demand
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BOM: Bill of
Materials
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BOPP:
Biaxially Oriented Polypropylene
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BP:
British Pharmacopoeia
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BPR: Batch Packaging Record
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BRMS:
Biologics Regulatory Management System
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BSE:
Bovine spongiform encephalopathy (mad cow disease)
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CAPA:
Corrective and preventive action
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CBE:
Changes being effected
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CBER:
Center for Biologics Evaluation and Research (FDA)
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CCIT:
Container closure integrity test
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CDER:
Center for Drug Evaluation and Research (FDA)
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CDSCO: Central drug standard control organization (India)
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CEP:
Certification of suitability of European Pharmacopoeia monographs
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CFR:
Code of Federal Regulations
CFM: Cubic
Feet Per Minute
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CFU: Colony
Forming Unit
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cGMP: Current
Good Manufacturing Practices
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CIP:
Clean in place
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CMC: Chemistry,
manufacturing and controls
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CMS:
Continuous monitoring system
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COA:
Certificate of analysis
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COS:
Certificate of suitability
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COPP:
Certificate of Pharmaceutical Products
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CPP: Critical Process Parameter
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CQA: Critical Quality Attribute
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CTD:
Common technical document
DCP: Di-Basic
Calcium Phosphate
DHA: Decosahexanoic
Acid
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DMF:
Drug master file
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DOP: Dioctyl
Phthalate
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DQ: Design
Qualification
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EDMF:
European drug master file
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EDQM:
European Directorate for the Quality of Medicines
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EH&S: Environmental health and safety
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EIR:
establishment inspection report (FDA)
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EMEA:
European Medicines Agency (formerly European Medicines Evaluation Agency)
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EP:
European Pharmacopoeia
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EPS:
Expanded polystyrene
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ETP:
Effluent Treatment Plant
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EU:
Endotoxin unit
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EU:
European Union
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FAT: Factory
Acceptance Testing
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FBD:
Fluid-bed dryer
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FDA: Food
and Drug Administration, United States
FDAP: Food
and Drugs Administration, Philippines
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FDC:
Fixed Dose Combination
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FEFO:
First expiry first out
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FG:
Finished Goods
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FIFO:
First in first out
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FMEA:
Failure modes and effect analysis
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FOI:
Freedom of information
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GAMP:
Good automated manufacturing practice
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GC:
Gas Chromatography
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GCLP:
Good clinical laboratory practice
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GCP:
Good clinical practice
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GDP:
Good distribution practice
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GEP:
Good engineering practice
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GGP:
good guidance practice
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GIT:
Gastrointestinal Tract
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GLP:
Good laboratory practice
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GMO:
Genetically modified organism
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GMP:
Good manufacturing practice
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GPT: Growth
Promotion Test
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GRAS/E: Generally recognized as safe and effective
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GRP:
Good review practice
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HACCP:
Hazard analysis critical control point
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HDPE: High
Density Polyethylene
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HEPA:
High efficiency particulate air (filter)
HLV:
Hand Level Valve
HMI: Human
Machine Interface
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HPLC:
High performance liquid chromatography
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HSA: Health
Sciences Authority, Singapore
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HVAC:
Heating, ventilating, and air conditioning
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ICH:
International Conference on Harmonization
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IH: In
house
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IM:
Intramuscular
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IND:
Investigational new drug
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INDA:
Investigational new drug application
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IP: Indian
Pharmacopeia
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IPA:
Isopropyl Alcohol
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IPS:
In process control
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IQ:
Installation qualification
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IR:
Immediate release
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ISO:
International Organization for Standardization
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ISPE:
International Society for Pharmaceutical Engineering
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IV:
Intravenous
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JP:
Japanese Pharmacopoeia
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KOS:
Knowledge organization system
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LAF:
Laminar air flow
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LAL: Limulus Amoebocyte Lysate
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LD:
Lethal dose
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LD50:
Lethal dose where 50% of the animal population die
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LDPE: Low
Density Polyethylene
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LIMS:
Laboratory Information Management System
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LIR: Laboratory Investigation Report
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LOD:
Loss on drying
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LOD:
Limit of detection
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LOQ:
Limit of quantification
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LR:
Laboratory Reagent
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LVPs: Large
Volume Parenterals
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MA:
Marketing Authorisation
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MAA:
Marketing Authorisation Application
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MAC: Maximum
Allowable Carryover
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MCC: Medicines
control council (South Africa)
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MDD:
Maximum daily dose
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MFR: Master
Formula Record
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MEDSAFE: Medicines
and medicinal devices safety authority (New zealand)
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MHRA:
Medicines and Healthcare products Regulatory Agency (UK)
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MOA: Method
Of Analysis
MRP: Maximum
Retail Price
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MSDS:
Material Safety Data Sheets
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NCE:
New chemical entity
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NDA:
New Drug Application
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NF:
National Formulary
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NIR: Near
Infra Red Spectroscopy NSF: National sanitation foundation |
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NON:
Notice of non-compliance (Canada)
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ODI: Orally
Disintegrating Tablet
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OQ:
Operation Qualification
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OSD: Oral
Solid Dosage
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OSHA:
Occupational Safety And Health Administration
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OTC:
Over-the-counter
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OOS:
Out of specification
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OOT:
Out of trend
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PAC:
Post-approval changes
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PAO: Poly
alpha olefin
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PAT: Process
Analytical technology
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PET:
Preservative efficacy test
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PET:
Polyethylene
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PIC/S: Pharmaceutical Inspection Co-operation
Scheme
PIS: Product
Information Sheet
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PLC: Programmable Logic Control
PLM: Planetary
Mixer
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PQ:
Performance Qualification
PSI: Pound per Square Inch
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PVC:
Polyvinyl Chloride
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PVDC: Polyvinylidene
Chloride
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PW:
Purified Water
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QA : Quality Assurance
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QC: Quality Control
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QbD:
Quality by design
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QM: Quality
Manual
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QSD: Quality System Dossier
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QSM : Quality
System Management
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QMS: Quality
Management System
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RH:
Relative humidity
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RLAF:
Reverse laminar air flow
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RLD:
Reference listed drug
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RM:
Raw material
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RO: Reverse
Osmosis
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ROPP: Roll On
Pilfer Proof
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RS: Related
Substance
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SAL:
Sterility Assurance Level
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SAT: Site
Acceptance Testing
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SDN:
Screening Deficiency Notice (Canada)
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SIP:
Sterilization in place/Steam in place
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SLS: Sodium
Lauryl Sulphate
SPP: Sodium
Propyl Paraben
SSG: Sodium
Starch Glycolate
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SMF:
Site master file
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SOP:
Standard operating procedure
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SPE: Society for Pharmaceutical Engineering
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SUPAC:
Scale-up and post approval changes
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SVP: Small Volume Parenteral
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TC:
Thermocouple
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TDS: Total
Dissolved Solids
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TGA: Therapeutics
goods administration (Australia)
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TOC:
Total organic carbon
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TSE:
Transmissible spongiform encephalopathy
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USFDA: United states foods and
drugs administration
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USP: United
States Pharmacopeia
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USP-NF: United States Pharmacopeia-National Formulary
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URS: User
Requirement Specification
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VAI:
Voluntary action indicated
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VMP: Validation
Master Plan
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WFI:
Water for injection
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WHO:
World Health Organisation
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WL:
Warning letter
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