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.
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%

Saturday, August 5, 2017

ABBREVIATION USED IN PHARMACEUTICALS


ABBREVIATION:  Abbreviation is an shortened form of an word, the most commonly used abbreviations in pharmaceutical company                                              
AADA: Abbreviated antibiotic drug application
ADE: Adverse drug event
ADME: Absorption, distribution, metabolism, and excretion
AHU: Air Handling Unit
ANDA: Abbreviated new drug application
ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)
AP: Applicants Part (of EDMF)
API: Active pharmaceutical ingredient
APR: Annual product review (APQR – Annual product quality
         review)
AQL: Acceptable quality level
AR: Analytical Reagent
ASHRAE: American Society of heating, Refrgeration and
 Air Conditioning Engineers
ASM: Active Substance Manufacturer
ASMF: Active Substance Master File
AST: Accelerated stability testing
ASTM: American Society for Testing and Materials
BA/BE: Bioavailability/bioequivalence
BCS: Biopharmaceutical classification system
BDR: Batch Distribution Record
BET: Bacterial Endotoxin Test
BFS: Blow Fill Seal
BI: Biological Indicator
BMR: Batch Manufacturing/Processing Record
BOD: Biological Oxygen Demand
BOM: Bill of Materials
BOPP: Biaxially Oriented Polypropylene
BP: British Pharmacopoeia
BPR:  Batch Packaging Record
BRMS: Biologics Regulatory Management System
BSE: Bovine spongiform encephalopathy (mad cow disease)
CAPA: Corrective and preventive action
CBE: Changes being effected
CBER: Center for Biologics Evaluation and Research (FDA)
CCIT: Container closure integrity test
CDER: Center for Drug Evaluation and Research (FDA)
CDSCO: Central drug standard control organization (India)
CEP: Certification of suitability of European Pharmacopoeia monographs
CFR: Code of Federal Regulations
CFM: Cubic Feet Per Minute
CFU: Colony Forming Unit
cGMP: Current Good Manufacturing Practices
CIP: Clean in place
CMC: Chemistry, manufacturing and controls
CMS: Continuous monitoring system
COA: Certificate of analysis
COS: Certificate of suitability
COPP: Certificate of Pharmaceutical Products
CPP: Critical Process Parameter
CQA: Critical Quality Attribute
CTD: Common technical document
DCP: Di-Basic Calcium Phosphate
DHA: Decosahexanoic Acid
DMF: Drug master file
DOP: Dioctyl Phthalate
DQ: Design Qualification
EDMF: European drug master file
EDQM: European Directorate for the Quality of Medicines
EH&S: Environmental health and safety
EIR: establishment inspection report (FDA) 
EMEA: European Medicines Agency (formerly European Medicines Evaluation Agency)
EP: European Pharmacopoeia
EPS: Expanded polystyrene
ETP: Effluent Treatment Plant
EU: Endotoxin unit
EU: European Union
FAT: Factory Acceptance Testing
FBD: Fluid-bed dryer
FDA: Food and Drug Administration, United States
FDAP: Food and Drugs Administration, Philippines
FDC: Fixed Dose Combination
FEFO: First expiry first out
FG: Finished Goods
FIFO: First in first out
FMEA: Failure modes and effect analysis
FOI: Freedom of information
GAMP: Good automated manufacturing practice
GC: Gas Chromatography
GCLP: Good clinical laboratory practice
GCP: Good clinical practice
GDP: Good distribution practice
GEP: Good engineering practice
GGP: good guidance practice
GIT: Gastrointestinal Tract
GLP: Good laboratory practice
GMO: Genetically modified organism
GMP: Good manufacturing practice
GPT: Growth Promotion Test
GRAS/E: Generally recognized as safe and effective
GRP: Good review practice
HACCP: Hazard analysis critical control point
HDPE: High Density Polyethylene
HEPA: High efficiency particulate air (filter)
HLV: Hand Level Valve
HMI: Human Machine Interface
HPLC: High performance liquid chromatography 
HSA: Health Sciences Authority, Singapore
HVAC: Heating, ventilating, and air conditioning
ICH: International Conference on Harmonization
IH: In house
IM: Intramuscular
IND: Investigational new drug
INDA: Investigational new drug application
IP: Indian Pharmacopeia
IPA: Isopropyl Alcohol
IPS: In process control
IQ: Installation qualification
IR: Immediate release
ISO: International Organization for Standardization
ISPE: International Society for Pharmaceutical Engineering
IV: Intravenous
JP: Japanese Pharmacopoeia
KOS: Knowledge organization system
LAF: Laminar air flow
LAL:  Limulus Amoebocyte  Lysate
LD: Lethal dose
LD50: Lethal dose where 50% of the animal population die
LDPE: Low Density Polyethylene
LIMS: Laboratory Information Management System
LIR:  Laboratory Investigation Report
LOD: Loss on drying
LOD: Limit of detection
LOQ: Limit of quantification
LR: Laboratory Reagent
LVPs: Large Volume Parenterals
MA: Marketing Authorisation
MAA: Marketing Authorisation Application
MAC: Maximum Allowable Carryover
MCC: Medicines control council (South Africa)
MDD: Maximum daily dose
MFR: Master Formula Record
MEDSAFE: Medicines and medicinal devices safety authority (New zealand)  
MHRA: Medicines and Healthcare products Regulatory Agency (UK)
MOA: Method Of Analysis
MRP: Maximum Retail Price
MSDS: Material Safety Data Sheets
NCE: New chemical entity
NDA: New Drug Application
NF: National Formulary
NIRNear Infra Red Spectroscopy
NSF: National sanitation foundation 
NON: Notice of non-compliance (Canada)
ODI: Orally Disintegrating Tablet
OQ: Operation Qualification
OSD: Oral Solid Dosage
OSHA: Occupational Safety And Health Administration
OTC: Over-the-counter
OOS: Out of specification
OOT: Out of trend
PAC: Post-approval changes
PAO: Poly alpha olefin
PAT: Process Analytical technology
PET: Preservative efficacy test
PET: Polyethylene
PIC/S:  Pharmaceutical Inspection Co-operation Scheme
PIS: Product Information Sheet
PLC:  Programmable Logic Control
PLM: Planetary Mixer
PQ: Performance Qualification
PSI:  Pound per Square Inch
PVC: Polyvinyl Chloride
PVDC: Polyvinylidene Chloride
PW: Purified Water
QA :  Quality Assurance
QC:  Quality Control
QbD: Quality by design
QM: Quality Manual
QSD:  Quality System Dossier
QSM : Quality System Management
QMS: Quality Management System
RH: Relative humidity
RLAF: Reverse laminar air flow
RLD: Reference listed drug
RM: Raw material
RO: Reverse Osmosis
ROPP: Roll On Pilfer Proof
RS: Related Substance
SAL: Sterility Assurance Level
SAT: Site Acceptance Testing
SDN: Screening Deficiency Notice (Canada)
SIP: Sterilization in place/Steam in place
SLS: Sodium Lauryl Sulphate
SPP: Sodium Propyl Paraben
SSG: Sodium Starch Glycolate
SMF: Site master file
SOP: Standard operating procedure
SPE:  Society for Pharmaceutical Engineering
SUPAC: Scale-up and post approval changes
SVP:  Small Volume Parenteral
TC: Thermocouple
TDS: Total Dissolved Solids
TGA: Therapeutics goods administration (Australia)
TOC: Total organic carbon
TSE: Transmissible spongiform encephalopathy
USFDA: United states foods and drugs administration
USP: United States Pharmacopeia
USP-NF: United States Pharmacopeia-National Formulary
URS: User Requirement Specification
VAI: Voluntary action indicated
VMP: Validation Master Plan
WFI: Water for injection
WHO: World Health Organisation
WL: Warning letter