Pharma treasures is an informatory site, which shares pharma related articles. The ultimate goal of this site is to become a knowledge hub by gathering all pharma related technical information under one roof...... This blog mainly talks about QMS,cGMP,Regulatory Filings & Guidelines,Validation & Qualifications,Drug Stability,FDA 483s &Media Fill. Hope this blog will cater the needs of both fresher’s and experienced professionals.
Saturday 21 December 2013
Betalactam Antibiotics Manufacturing Controls - FDA & GMP requirements
|
Betalactam
Antibiotics – Manufacturing Controls FDA
& GMP requirements
|
Betalactam antibiotics are cell wall synthesis inhibitors, which
inhibit the growth of bacteria by interfering a specific step in bacterial cell
wall synthesis. Beta-lactam antibiotics, including penicillins and the
non-penicillin classes, share a basic chemical structure that includes a
three-carbon, one-nitrogen cyclic amine structure known as the beta-lactam
ring. The side chain associated with the beta-lactam ring is a variable group
attached to the core structure by a peptide bond; the side chain variability
contributes to antibacterial activity.
Beta-lactam antibiotics include the following five classes:
·
penicillins (e.g.,
ampicillin, oxacillin)
·
cephalosporins (e.g.,
cephalexin, cefaclor)
·
penems (e.g., imipenem,
meropenem)
·
carbacephems (e.g.,
loracarbef)
·
monobactams (e.g.,
aztreonam)
Allergic reactions associated with penicillins
and non-penicillin beta-lactams range from rashes to life-threatening
anaphylaxis. Immunoglobulin E (IgE) antibodies mediate the immediate
hypersensitivity reactions that are responsible for the symptoms of hay fever,
asthma, hives, and anaphylactic shock. IgE-mediated hypersensitivity reactions
are of primary concern because they may be associated with significant
morbidity and mortality.
It is difficult to define the minimal dose below which allergic
responses are unlikely to occur in humans. There is a lack of suitable animal
or receptor testing models that are predictive of human sensitivity. The
threshold dose at which allergenic response could occur is extremely low and
difficult to detect with current analytical methods.
Drug cross-contamination is the contamination of
one drug with one or more different drugs. During drug manufacturing process, if
a drug manufacturer uses same equipment chain for betalactam and non betalactam drugs, there
could be a possibility of cross
contamination which can result in hypersensitive exaggerated allergic immune
response in some people.
Manufacturing operations of betalactam drugs to
be controlled to avoid cross contamination with other drugs, because
1. Betalactum antibiotics may cause anaphylatic shock and anaphylaxis or life threatening allergic reactions.
2.Mode of action of Betalacctum antibiotics are more or less cytotoxic.
3.Untoward consumption of betalactum antibiotics as contaminant in other product even in smaller amount may result in the development of untoward drug resistance or antibiotic resistance for betalactum antibiotics and when ever desired,betalactum drugs may not be effective in individuals who got betalactum antibiotic as cotaminant.
Regulatory Requirements for
Betalactam Manufacturing
FDA insists the drug manufacturers that operations
relating to the manufacture, processing, and packing of penicillin shall be
performed in facilities separate from those used for other drug products for
human use.” However, FDA has clarified that separate buildings may not be
necessary, provided that the section of the manufacturing facility dedicated to
manufacturing penicillin is isolated (i.e., completely and comprehensively
separated) from the areas of the facility in which non-penicillin products are
manufactured. Manufacturers must completely separate air handling systems for
penicillin from those used for other drugs for human use. Additionally,
manufacturers to test non-penicillin drug products for penicillin where the
possibility of exposure to cross-contamination exists, and prohibits
manufacturers from marketing such products if detectable levels of penicillin
are found.
Elution Modes in HPLC
|
Elution
Modes in HPLC
|
In
adsorption chromatography, solvent molecules compete with solute molecules for
sites on the stationary phase. Elution can be described as a displacement of
solute from the stationary phase by solvent.
Elution Modes in HPLC
1.Isocratic
elution–Performed with a single solvent or constant
solvent mixture (i.e The composition of the mobile phase kept constant throughout
elution).
2.Gradient
elution–Continuous change of solvent composition to
increase eluent strength (i.e The composition of the mobile phase varied during elution).
The main purpose of gradient elution is to move strongly
retained components of the mixture faster, but having the least retained
component well resolved.
Starting with the low content of the organic component in the
eluent the least retained components are allowed to be separated. Strongly
retained components will sit on the adsorbent surface on the top of the column,
or will move very slowly.
When the amount of organic component increased then strongly
retained components will move faster and faster, because of the steady increase
of the competition for the adsorption sites.
Gradient elution also increase quasi-efficiency of the column.
In the isocratic elution, the longer a component is retained, the wider its
peak. In gradient elution, especially with the smooth gradient shape without a
flat regions, the tail of the peak is always under the influence of the
stronger mobile phase when compared to the peak front. Thus, molecules on the
tail of the chromatographic zone (peak) will move faster. This will tend to
compress zone and narrow the resultant peak.
Performance of the gradient elution is strongly dependent on the
instrumentation. Two main points the chromatographer needs to know about his
instrument:
1.How large the volume between the component mixing point and
column inlet is. For the low-pressure gradient systems this volume usually
correspond to the pump volume, and about 2 - 3 ml.
2.How well does the system mix eluent components. If the system
does not mix components well then it will supply for the certain time one
component then another and so on. Chromatographic performance of such system
will be very low especially for the least retained components.
Friday 20 December 2013
Common Abbreviations Used In Pharmaceutical Industry
Common Abbreviations & Acronyms Used In
Pharmaceuticals
|
Pharmatreasures
abbreviations data base is the best available abbreviation collection which extensively
lists out common and useful acronyms and abbreviations related to the
pharmaceutical industry.
This collection includes, abbreviations connected with Regulatory affairs, Pharmacovigilance (PV),
Clinical trials, cGMP, Quality Assurance, Quality Control etc. This data base
is updated on regular basis (last updated on 10th March 2020) to
catch up new terminologies.
AADA:
|
Abbreviated Antibiotic Drug Application
|
AAO:
|
American
Academy of Ophthalmology
|
ADE:
|
Adverse
Drug Event
|
ADME:
|
Absorption,
Distribution, Metabolism, and Excretion
|
ADI:
|
Acceptable Daily Intake
|
ADR:
|
Adverse Drug Reaction
|
ADRS:
|
Adverse Drug Reporting System
|
AGDUFA:
|
Animal Generic Drug User Fee Act
|
AHU:
|
Air
Handling Unit
|
ALCOA:
|
Acronym
referring to Attributable, Legible, Contemporaneous, Original and Accurate.
|
ALCOA PLUS:
|
Acronym
referring to Attributable, Legible, Contemporaneous, Original and Accurate
‘plus’ Complete, Consistent, Enduring, and Available.
|
AME:
|
Absorption, Metabolism, Excretion
|
ANDA:
|
Abbreviated
New Drug Application
|
ANOVA:
|
Analysis of Variance
|
ANVISA:
|
Agência
Nacional de Vigilância Sanitária (National
Health Surveillance Agency Brazil)
|
AP:
|
Applicants
Part (of EDMF)
|
API:
|
Active
Pharmaceutical Ingredient
|
APIC:
|
Active Pharmaceutical Ingredients
Committee
|
APR:
|
Annual
product review (APQR – Annual product quality review)
|
AQL:
|
Acceptable
Quality Level
|
AR:
|
Analytical
Reagent
|
ARB:
|
Angiotensin Receptor Blocker
|
ASHRAE:
|
American Society of heating,
Refrgeration and
Air
Conditioning Engineers
|
ASM:
|
Active Substance Manufacturer
|
ASME:
|
American Society of Mechanical
Engineers
|
ASMF:
|
Active Substance Master File
|
ASQ:
|
American Society for Quality
|
AST:
|
Accelerated Stability Testing
|
ASTM:
|
American Society for Testing and
Materials
|
BA/BE:
|
Bioavailability/Bioequivalence
|
BCS:
|
Biopharmaceutical Classification
System
|
BET:
|
Bacterial Endotoxin Test
|
BFS:
|
Blow Fill Seal
|
BI:
|
Biological Indicator
|
BIND:
|
Biological Investigational New Drug
|
BLA:
|
Biologics License Application (CBER)
|
BMI:
|
Body Mass Index
|
BMR:
|
Batch Manufacturing/Processing
Record
|
BOD:
|
Biological Oxygen Demand
|
BOM:
|
Bill of Materials
|
BOPP:
|
Biaxially Oriented Polypropylene
|
BP:
|
British Pharmacopoeia
|
BPC:
|
Bulk Pharmaceutical Chemical
|
BPR:
|
Batch Packaging Record
|
BRMS:
|
Biologics Regulatory Management
System
|
BSA:
|
Body Surface Area
|
BSE:
|
Bovine Spongiform Encephalopathy
(Mad Cow Disease)
|
BSI:
|
British Standards Institute
|
BST:
|
Bovine Somatotropin
|
BsUFA:
|
Biosimilar User Fee Act
|
BTD:
|
Breakthrough Therapy Designation
|
BVC:
|
British Veterinary Codex
|
CA:
|
Chemical Abstracts
|
CAPA:
|
Corrective and preventive action
|
CANDA:
|
Computer Assisted New Drug Application
|
CAPLA:
|
Computer Assisted Product License Application
|
CAS:
|
Chemical Abstracts Service
|
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)
|
CDRH:
|
Center for Devices and Radiological
Health (FDA)
|
CDSCO:
|
Central Drug Standard Control
Organization (India)
|
CEP:
|
Certification of Suitability of European
Pharmacopoeia Monographs
|
CFR:
|
Code of Federal Regulations
|
CFU:
|
Colony Forming Unit
|
CJD:
|
Creutzfeldt Jakob Disease
|
cGMP:
|
Current Good Manufacturing Practices
|
CIP:
|
Clean in Place
|
CMC:
|
Chemistry, Manufacturing and
Controls
|
CMO:
|
Contract Manufacturing Organization
|
CMS:
|
Continuous Monitoring System
|
CNS:
|
Central Nervous System
|
COA:
|
Certificate of Analysis
|
COI:
|
Conflict of Interest
|
COMSTAT:
|
Compliance Status Information System
|
COP:
|
Clean out of Place
|
COPP:
|
Certificate of Pharmaceutical
Products
|
CoS:
|
Certificate of Suitability
|
CPI:
|
Consumer Price Index
|
CPP:
|
Critical Process Parameter
|
CQA:
|
Critical Quality Attribute
|
CR:
|
Complete Response (Letter)
|
CRO:
|
Contract Research Organization
|
CRS:
|
Contamination Response System
|
CSA:
|
Controlled Substances Act
|
CSV:
|
Computer System Validation
|
CT:
|
Clinical Trial
|
CTD:
|
Common Technical Document
|
CVMP:
|
Committee on Veterinary Medical
Products (EMA)
|
DI:
|
Deionized Water
|
DIN:
|
Drug Identification Number (Canada)
|
DMF:
|
Drug Master File
|
DOA:
|
Drugs of Abuse
|
DOE:
|
Design of Experiment
|
DOP:
|
Dioctyl Phthalate
|
DQ:
|
Design Qualification
|
DP:
|
Drug Product
|
DPC-PTR Act:
|
Drug Price Competition and Patent
Trade Restoration Act of 1984
|
DPI:
|
Dry Powder Inhaler
|
DS:
|
Drug Substance
|
DUNS:
|
Data Universal Numbering System
|
EC:
|
European Community
|
ED:
|
Effective Dose
|
EDMF:
|
European Drug Master File
|
EDQM:
|
European Directorate for the Quality
of Medicines
|
EFOIA:
|
Electronic Freedom of Information
Act
|
EFPIA:
|
European Federation of Pharmaceutical
Industries and Associations
|
EFTA:
|
European Free Trade Association
|
EH&S:
|
Environmental Health and Safety
|
EIA:
|
Enzyme Immunoassay
|
EIR:
|
Establishment
Inspection Report (FDA)
|
EMA:
|
European Medicines Agency (Formerly
European Medicines Evaluation Agency -EMEA)
|
EP:
|
European Pharmacopoeia
|
EPAR:
|
European Public Assessment Reports
(EMEA)
|
EPS:
|
Expanded Polystyrene
|
ERP:
|
Emergency Response Plan
|
ERS:
|
Electronic Regulatory Submission
|
ERSR:
|
Electronic Regulatory Submissions
and Review
|
ESG:
|
Electronic Submissions Gateway
|
ETP:
|
Effluent Treatment Plant
|
EU:
|
Endotoxin Unit
|
EU:
|
European Union (EU 27)
|
FAI:
|
Further Action Indicated (FDA)
|
FAR:
|
Field Alert Report (FDA)
|
FAT:
|
Factory Acceptance Testing
|
FBD:
|
Fluid-Bed Dryer
|
FDA:
|
Food and Drug Administration, United
States
|
FDA Form 482:
|
FDA form for Notice of Inspection
|
FDA-483:
|
FDA form Used as a Written Notice of
Deficiencies Found in Inspections
|
FDA-SRS:
|
Spontaneous Reporting System of the
Food and Drug Administration
|
FDC:
|
Food, Drug, & Cosmetic
|
FDC:
|
Fixed Dose Combination
|
FDCA:
|
Federal Food, Drug, and Cosmetic Act
of 1938
|
FFDCA:
|
Federal Food, Drug, and Cosmetic Act
of 1938
|
FEI:
|
Facility Establishment Identifier
|
FEFO:
|
First Expiry First Out
|
FG:
|
Finished Goods
|
FIFO:
|
First in First Out
|
FMEA:
|
Failure Modes and Effect Analysis
|
FMECA:
|
Failure Modes Effects and Criticality
Analysis
|
FOI:
|
Freedom of Information
|
FOIA:
|
Freedom of Information Act
|
FR:
|
Federal Register
|
FTA:
|
Fault Tree Analysis
|
GAMP:
|
Good Automated Manufacturing
Practice
|
GARR:
|
Grants Application Review Request
|
GC:
|
Gas Chromatography
|
GCLP:
|
Good Clinical Laboratory Practice
|
GCLP:
|
Good Clinical laboratory practice
|
GCP:
|
Good Clinical practice
|
GDP:
|
Good Distribution practice
|
GEO:
|
Genetically Engineered Organism
|
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:
|
Generally Recognized as Safe
|
GRAS/E:
|
Generally Recognized as Safe and
Effective
|
GRP:
|
Good
Review Practice
|
GUDUFA:
|
Generic Drug User Fee Amendments
|
GxP:
|
"Good x"" Practices
|
HACCP:
|
Hazard Analysis Critical Control
Point
|
HCI:
|
Human-Computer Interaction
|
HDPE:
|
High Density Polyethylene
|
HEPA:
|
High
Efficiency Particulate Air (filter)
|
HMI:
|
Human Machine Interface
|
HPLC:
|
High Performance Liquid
Chromatography
|
HSA:
|
Health Sciences Authority, Singapore
|
HVAC:
|
Heating, Ventilating, and Air
Conditioning
|
ICAH:
|
International Council on
Harmonisation (Formally known as International Conference on Harmonisation)
|
IH:
|
In House
|
IM:
|
Intramuscular
|
IND:
|
Investigational New Drug
|
INDA:
|
Investigational New Drug Application
|
INN:
|
International Nonproprietary Name
|
IP:
|
Indian Pharmacopeia
|
IPA:
|
Isopropyl Alcohol
|
IPC:
|
In process Control
|
IPCS:
|
International Programme on Chemical
Safety (WHO)
|
IPEC:
|
International Pharmaceutical
Excipients Council
|
IQ:
|
Installation Qualification
|
IR:
|
Immediate Release
|
IR:
|
Information Request (Letter)
|
ISO:
|
International Organization for
Standardization
|
ISPE:
|
International Society for
Pharmaceutical Engineering
|
IUPAC:
|
International Union of Pure and
Applied Chemistry
|
IV:
|
Intravenous
|
JP:
|
Japanese Pharmacopoeia
|
KOS:
|
Knowledge Organization System
|
LAF:
|
Laminar air flow
|
LAL:
|
Limulus Amoebocyte Lysate
|
LAN:
|
Local Area Network
|
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
|
LOA:
|
Letter of Agreement
|
LOA:
|
Letter of Authorization
|
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
|
mAb:
|
Monoclonal Antibody
|
MAC:
|
Maximum
Allowable Carryover
|
MAH:
|
Marketing Authorisation Holder (EC)
|
MDA:
|
Medical Devices Agency (UK)
|
MDD:
|
Maximum
Daily Dose
|
MDI:
|
Metered Dose Inhaler
|
MDR:
|
Medical Device Reporting
|
MDUFMA:
|
Medical Device User Fee and
Modernization Act of 2002
|
MDUFSA:
|
Medical Device User Fee
Stabilization Act of 2005
|
MFR:
|
Master
Formula Record
|
MEDSAFE:
|
Medicines
and Medicinal Devices Safety Authority (New Zealand)
|
MHRA:
|
Medicines
and Healthcare Products Regulatory Agency (UK)
|
MLD:
|
Minimum Lethal Dose
|
MOA:
|
Method
Of Analysis
|
MRA:
|
Mutual Recognition Agreement
|
MS:
|
Mass Spectroscopy
|
MSDS:
|
Material
Safety Data Sheets
|
MTD:
|
Maximum Tolerated Dose
|
NCE:
|
New
Chemical Entity
|
NAI:
|
No Action Indicated(FDA)
|
NCR:
|
Non-Conformance Report
|
NDA:
|
New
Drug Application
|
NDC:
|
National Drug Code (FDA)
|
NF:
|
National
Formulary
|
NIR:
|
Near
Infra Red Spectroscopy
|
NME:
|
New Molecular Entity
|
NMR:
|
Nuclear Magnetic Resonance Spectroscopy
|
NMT:
|
Not More Than
|
NOAEL:
|
No Observable Adverse Effect Level
|
NOC:
|
Notice of Compliance (Canada)
|
NOD:
|
Notice of Deficiency (Canada
|
NON:
|
Notice
of Non-compliance (Canada)
|
NSAID:
|
Non-Steroidal Anti-Inflammatory Drug
|
OAI:
|
Official Action Indicated(FDA)
|
ODI:
|
Orally
Disintegrating Tablet
|
OEL:
|
Occupational Exposure Level
|
OQ:
|
Operation
Qualification
|
OSD:
|
Oral
Solid Dosage
|
OSHA:
|
Occupational
Safety And Health Administration
|
OOS:
|
Out
of Specification
|
OOT:
|
Out
of Trend
|
OTC:
|
Over-the-counter
|
PAC:
|
Post-approval
changes
|
PACT:
|
Post-Approval Commitment Tracking
|
PAI:
|
Pre-Approval Inspection(FDA)
|
PAO:
|
Poly
alpha olefin
|
PAS:
|
Prior
Approval Supplement(FDA)
|
PAT:
|
Process
Analytical technology
|
PD:
|
Pharmacodynamics
|
PDA:
|
Parenteral Drug Association
|
PDE:
|
Permitted Daily Exposure
|
PDUFA:
|
Prescription Drug User Fee Act
|
PEPFAR:
|
Presidential Emergency Plan for AIDS
Relief
|
PET:
|
Preservative
Efficacy Test
|
PET:
|
Polyethylene
|
Ph.Eur.:
|
Pharmacopeia Europa
|
PIC/S:
|
Pharmaceutical
Inspection Co-operation Scheme
|
PK:
|
Pharmacokinetics
|
PLA:
|
Product License Application (CBER)
|
PLAIR:
|
Pre-Launch Activities Importation
Request (USFDA)
|
PLC:
|
Programmable
Logic Control
|
PMA:
|
Premarket Approval
|
PMF:
|
Public Master File
|
PMS:
|
Postmarketing Surveillance
|
POM:
|
Prescription-only medicine (UK)
|
ppb:
|
Parts per Billion
|
PPE:
|
Personal protective equipment
|
Ppm:
|
Parts per Million
|
PPM:
|
Planned Preventive Maintenance
|
PQ:
|
Performance
Qualification
|
PQG:
|
Pharmaceutical Quality Group
|
PUDUFA:
|
Prescription Drug User Fee Act (FDA)
|
PV:
|
Process Validation
|
PVC:
|
Polyvinyl
Chloride
|
PVDC:
|
Polyvinylidene
Chloride
|
PW:
|
Purified
Water
|
QA
:
|
Quality
Assurance
|
QC:
|
Quality
Control
|
QbD:
|
Quality
by design
|
QbR:
|
Question-based Review
|
QD:
|
Once Daily
|
QID:
|
Four Times a Day
|
QM:
|
Quality
Manual
|
QMS:
|
Quality Management System
|
QOD:
|
Every Other Day
|
QP:
|
Qualified Person (EU)
|
QRM:
|
Quality
Risk Management
|
QSD:
|
Quality
System Dossier
|
QSM:
|
Quality
System Management
|
QU:
|
Quality Unit
|
RCR:
|
Risk Control Review
|
R&D:
|
Research and Development
|
REMS:
|
Risk Evaluation and Mitigation Strategy
|
RH:
|
Relative
Humidity
|
RLAF:
|
Reverse
Laminar Air Flow
|
RLD:
|
Reference
listed drug
|
RM:
|
Raw
Material
|
RMS:
|
Reference Member State (Europe)
|
RO:
|
Reverse
Osmosis
|
ROPP:
|
Roll
On Pilfer Proof
|
RS:
|
Related
Substance
|
RTR:
|
Refuse
to Receive
|
Rx:
|
Prescription
|
SAL:
|
Sterility
Assurance Level
|
SAT:
|
Site
Acceptance Test
|
SDN:
|
Screening
Deficiency Notice (Canada)
|
SHPRA
|
South
African Health Products Authority [formally known as Medicines Control Council (MCC)]
|
SIP:
|
Sterilization
in lace/Steam in place
|
SLS:
|
Sodium
Lauryl Sulphate
|
SME:
|
Subject Matter Expert
|
SMF:
|
Site
Master File
|
SOP:
|
Standard
Operating Procedure
|
SPE:
|
Society
for Pharmaceutical Engineering
|
STD:
|
Sexually Transmitted Disease
|
SUPAC:
|
Scale-up
and Post Approval Changes
|
SVP:
|
Small
Volume Parenteral
|
TC:
|
Thermocouple
|
TDI:
|
Tolerable Daily Intake
|
TDS:
|
Total
Dissolved Solids
|
TGA:
|
Therapeutics
Goods Administration (Australia)
|
TLC:
|
Thin Layer Chromatography
|
TID:
|
Three Times a Day
|
TOC:
|
Total
Organic Carbon
|
TSE:
|
Transmissible
Spongiform Encephalopathy
|
UDI:
|
Unique Device Identification
|
UNII:
|
Unique Ingredient Identifier
|
USFDA:
|
United States Foods and Drugs
Administration
|
USP:
|
United
States Pharmacopeia
|
USPC:
|
U.S. Pharmacopeial Convention
|
USP-NF:
|
United
States Pharmacopeia-National Formulary
|
URS:
|
User
Requirement Specification
|
UTI:
|
Urinary tract infection
|
VAI:
|
Voluntary
Action Indicated
|
VMP:
|
Validation
Master Plan
|
WFI:
|
Water
for Injection
|
WHO:
|
World
Health Organisation
|
WL:
|
Warning
letter
|
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