In ancient times people use plants or animals matter to cure some sort of ailment or diseases by using home remedies. But now day’s medicine manufacturing is performed by chemical processing. Scientists first finds chemicals in plants or animals with their years of research and knowledge, then isolate these chemicals and try to make artificial chemical like original source chemical taken from plant or animals. After getting succeeded in making artificial synthetic chemical that cure targeted ailment or diseases, scientists start making medicines.
Now question is what a medicine contains? So medicines contain active drug called API (Active Pharmaceutical Ingredients) and excipient. API is active drug in any medicine which has therapeutic action to cure targeted ailment or diseases or disorder. While excipient is the non-active ingredient to support and enhance activity of drug product.
Where these medicines are manufactured?
Medicines are manufactured in Pharmaceutical manufacturing companies like Cipla, Glenmark, Lupin, Wockhardt, Alembic, Zydus, Mylan etc. First drug API is manufactured in API processing plants and then medicines are manufactured in Formulation plants by using API drugs and excipients. Medicines are manufactured in different dosage forms like OSD (Oral Solid Dosage) tablets, capsules, Liquid Syrups, Injectable etc. Means you get medicines prescribed by your doctor in forms like tablets, capsules, liquid syrups, injections. These medicines are manufactured under GMP (Good Manufacturing Practices) controlled environment. During medicines manufacturing temperature, humidity and air pressure is maintained by AHU (Air Handling Unit) to provide controlled environment and also to prevent cross contamination.
API Manufacturing Plant
API plants have different departments for dedicated function like Warehouse Department for storage receive, dispensing and dispatch of materials. Production Department or API Plant where batch (Batch is a specific quantity of a drug or other material that is intended to have a uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacturing.) processing happen, means chemical reactions are performed as per Batch Records and SOPs (Standard Operating Procedure) in chemical reactors.
Quality Control Department or QC Lab where testing of samples is performed. QC Sampling is a process of abstraction of a portion of material from a lot or a batch in such a way that the withdrawn sample is representative of that whole lot or batch. QC person perform testing by taking samples at different stages of API manufacturing. Quality Assurance Department for taking assurance of quality of manufactured API during processing. HR, Admin, IT, Finance, RA, CQA are other supporting departments.
Formulation Plant
Formulation plants also have different departments just like API manufacturing plants. Warehouse for storage, control, dispense and dispatch of materials and products. Production Department where medicines are produced, Different type of machines are used in production plants to make medicines like Isolators, Blending machine, compression machine, coating machine, granulation machine, capsule filling machine, inspection machine etc. are used to make medicines.
Packing Department where packaging of medicines is performed with the help of different machines. Blister machine, Bottle filling Counter machine, checkweigher, Unscrambler, Desiccant Sachet inserter, Cottoner, Capper Sealer, Labeller, CAM cartonator, Printer, Shipper Sealer are some machine used in packing department.
Quality Control Department or QC Lab where testing of samples is performed. QC person take sample during batch processing from different stages of manufacturing and analyse these sample in chemical labs using HPLC, GC, distillation, chromatography, titration and many more advance testing methods. Quality Assurance Department for taking assurance of quality of manufactured medicines. Safety Department to take care about safety of property building and peoples working in pharma industry
Drug development: journey of a Medicine manufacturing
During manufacturing medicines goes through different stages to become finished goods. First API and Excipient is dispensed by warehouse to production. Then these are mixed filtered and processed to produce intermediate product (A partly processed material, which undergoes further processing before it becomes a finished product). Then this intermediate product is processed further to produce finished product.
Finished product is a product that has completed all stages of manufacturing, and now this finish product is ready for packing. Now packing department perform packaging of finish product into finished goods. Finished goods are products that has completed all packing stages and packed into the final pack, as a result now ready for dispatch.
Dispatched finished goods are now become medicine after several processing testing manufacturing and packaging stages. Manufacturing of medicines is regulated by Regulatory Bodies around the world like USFDA (Unites States Food and Drug Administration from United States), WHO (World Health Organization), MHRA (Medicines and Healthcare Products Regulatory Agency from United Kingdom), CDSCO (Central Drug Standard Control Organization from India), TGA (Therapeutic Goods Administration from Australia), TPD (Therapeutic Product Directorate from Canada), EMA (European Medicines Agency from Europe) etc. Every manufactured medicine has manufacturing date, expiry date and shelf life. So now we understand these terms more clearly means what is manufacturing date, expiry date and shelf life.
What is Manufacturing Date?
Manufacturing date of the batch is the date on which actual batch activity is started so dispensing is always the first activity during any batch processing. So date of dispensing is considered as the manufacturing date.
What is Expiry Date?
Expiry date is the date till which a drug product is expected to remain within its approved specification. Or simply it is the date up to which the medicine is useful for its intended action.
What is Shelf Life?
Shelf life of medicine is a period of time during which a medicinal product or medicine, when stored properly under environments defined on the label is expected to comply with established specification. Or simply it is the time period up to which the medicine is useful for its intended action.
So today we learn what is medicine and how it is manufactured at Chemistry Notes Info. In upcoming posts we learn more about medicine manufacturing. Do you know what is GMP and why it is necessary during medicine manufacturing.
Books to learn how pharma drug medicines are manufactured
cGMP Current Good Manufacturing Practices for Pharmaceuticals, 2nd Edition
Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products
An Unfinished Agenda: My Life in the Pharmaceuticals Industry
Aliphatic Hydrocarbons are the type of hydrocarbons in which various carbon atoms joint together to form an open chain.
We just learn aliphatic compound definition. Now we learn more about aliphatic compounds (hydrocarbons) in below sections.
What are Aliphatic Hydrocarbons
Aliphatic compound is an aliphatic hydrocarbon compound containing Carbon atoms and Hydrogen atoms. Also aliphatic compound contains carbon and hydrogen in open straight or branched chain. We can also say that aliphatic hydrocarbon compounds are open chain compounds and do not contain aromatic rings. We study about aliphatic hydrocarbon under organic chemistry.
To understand in better way we take example of simplest aliphatic hydrocarbon i.e. Methane (CH4). Methan gas is a aliphatic compound. It contains 4 hydrogen atoms attached to a carbon atom.
Aliphatic hydrocarbon also contain some other atoms along with hydrogen that bound to carbon. These atoms are oxygen, nitrogen, chlorine, and sulfur but percentage of bounding of these atoms to carbon atom as compared to hydrogen is very less.
Classification of Aliphatic Hydrocarbons
Aliphatic Hydrocarbons can be classified into 2 categories i.e.
Saturated aliphatic-hydrocarbons
Unsaturated aliphatic-hydrocarbons.
Saturated Hydrocarbons
Saturated Aliphatic Hydrocarbons are the hydrocarbons, in which all the carbon valencies are fully saturated. So, all 4 carbon valencies are fully satisfied by 4 carbon atoms or groups. These type of compounds contains single covalent C-C & C-H type of bonds. These type of compounds generally not react with most compounds hence called as paraffins. IUPAC name for this class of compounds is alkanes. Example: Methane, Ethane, Propane etc.
Unsaturated Hydrocarbons
Unsaturated Aliphatic Hydrocarbons are the hydrocarbons, in which all the carbon valencies are not fully saturated. So, all 4 carbon valencies are not fully satisfied. Hence, they contain carbon carbon double bond or carbon carbon triple bond. As a result, 2 carbon atoms are linked by double or triple bond. So this class of compounds do not contain maximum possible hydrogen atoms therefore, they are unsaturated aliphatic hydrocarbons.
Unsaturated Aliphatic Hydrocarbons, further subdivided into 2 groups i.e.
Alkenes
Alkynes.
Alkenes
Alkenes are the Unsaturated Aliphatic Hydrocarbon containing carbon carbon double bond. Means 2 carbon atoms are linked together by double bond. Example: Olefins, Ethylene, Propene, etc.
Alkynes
Alkynes are the Unsaturated Aliphatic Hydrocarbon containing carbon carbon triple bond. Means, 2 carbon atoms are linked together by triple bond. Example: Acetylenes, Ethyne, Propyne, etc.
List of Aliphatic Compounds or Aliphatic Hydrocarbon
To list aliphatic compounds or aliphatic hydro-carbons, we create below table. We arrange all aliphatic compounds as per carbon atoms they contain.
Do you know, Hydrocarbons extracted from mother earth. And if this extraction process not followed is not done properly, it gives many side effects.
Side Effects of Hydrocarbon Extraction
Hydrocarbons are extracted with fracking process. Some of the side effects of this is contamination of water with methane and drilling chemicals. Emission of explosive and climate warming methane gas, cutting of Forest for extraction
You read these chemistry notes on Aliphatic Hydrocarbons by www.ChemistryNotesInfo.com . You can also Join us on Facebook to get more Chemistry Notes information.
1. Organic Chemistry, Volume One: Part I: Aliphatic Compounds Part II: Alicyclic Compounds
2. Densities of Aliphatic Hydrocarbon: Alkenes, Alkadienes, Alkynes, and Miscellaneous Compounds (Landolt-Bรถrnstein: Numerical Data and Functional Relationships in Science and Technology – New Series)
3. An Evaluation of Format as an Electron Donor to Facilitate Palladium-Catalyzed Destruction of Chlorinated Aliphatic Hydrocarbon
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List of famous scientists and their inventions
11 scientists and their brilliant inventions
Archimedes
The Archimedes’ Screw
Robert Hooke
discovered plant cells
Law of elasticity
Benjamin Franklin
Law of Conservation of Electric Charge
Invented bifocal spectacles
Also invented the Franklin stove
And invented the lightning rod
Alessandro Volta
First person to isolate methane gas
Invented the electric battery
Louis Pasteur
Discovered that some molecules have mirror images
Pasteur invented the process of pasteurization
Lord Kelvin
Gives the first two laws of thermodynamics
Invented devising equipment
William Crookes
Discovered and named the element Thallium
Invented electrical discharge tube
Wilhelm Rรถntgen
Discovered X-rays
Invented X-ray photography
Santiago Ramรณn y Cajal
Discovered neuron doctrine
Pierre Curie
Discovered radioactivity
Discovered piezoelectricity
Invented the piezoelectric quartz electrometer
Henry Moseley
Discovered the true basis of the periodic table
Invented the atomic battery
Famous Scientists and Their Inventions
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Books on Famous Scientists
Children’s Encyclopedia – This is a great book for children. This book contain info about scientists, their inventions and discoveries. With this book you can familiarize your children with important inventions and discoveries. You can purchase this book from Amazon.
Great Inventors and Their Inventions – This book contains twelve stories of great inventions, with a concluding chapter on famous inventors of today. It an awesome book about inventors and their inventions.
Abbreviations used in Pharmaceutical Manufacturing
As we know pharmaceutical manufacturing products i.e. medicines, life saving drugs have very high importance in our life. Today we learn about various abbreviations used in pharmaceutical manufacturing process steps or simply in pharmaceutical manufacturing companies. These short forms are used in every pharmaceutical manufacturing companies like pharmaceutical industry in USA, pharmaceutical industry in India, pharmaceutical industry in France, pharmaceutical industry in Canada, pharmaceutical industry in China, pharmaceutical industry in Japan etc. These short forms are also asked in various pharma interviews. So learn these Pharmaceutical Manufacturing Abbreviations and also share with your science friends working in pharma companies or studying pharmacy.
GMP : Good Manufacturing Practices cGMP : Current Good Manufacturing Practices
PVP : Process Validation Protocol
PVR : Process Validation Report
CVP : Cleaning Validation Protocol
CVR : Cleaning Validation Report
GDP : Good Documentation Practices
MQRM : Monthly Quality Review Meeting
QRM : Quality Risk Management
UCL : Upper control Limit
LCL : Lower control Limit
IPQA : In process Quality Assurance
LLC : Live line clearance
API: Active pharmaceutical ingredient
APQR: Annual product Quality review
AQL: Acceptable quality level
ASM: Active Substance Manufacturer
ASMF: Active Substance Master File
AST: Accelerated stability testing
CRT : Controlled Room Temperature
ASTM: American Society for Testing and Materials
BA: Bioavailability
BE : Bioequivalence
BET: Bacterial Endotoxin Test
BMR: Batch Manufacturing Record
BOD: Biological Oxygen Demand
BOM: Bill of Materials
BOPP: Biaxially Oriented Polypropylene
BP: British Pharmacopoeia
BPR: Batch Packaging Record
BSE: Bovine spongiform encephalopathy (mad cow disease)
CAPA: Corrective and preventive action
FMEA : Failure mode & Effect Analysis
RCA : Root cause Analysis
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 monograph
GC : Gas Chromatography
HSA: Health Sciences Authority, Singapore
ANVISA: Agรชncia Nacional de Vigilรขncia Sanitรกria (National Health Surveillance Agency Brazil
TGA: Therapeutics goods administration (Australia) USFDA: United states foods and drugs administration
FDA: Food and Drug Administration, United States
WHO: World Health Organisation
JP: Japanese Pharmacopoeia
MHRA: Medicines and Healthcare products Regulatory Agency (UK)
MEDSAFE: Medicines & medicinal devices safety authority (New zealand)
CQA: Critical Quality Attribute
MACO : Maximum allowable Carry over
ADE: Adverse drug event
PDE : Permitted Daily Dosage Exposure
ACU: Air Cooling Unit
AHU: Air Handling Unit
ANDA: Abbreviated new drug application
NDA : New drug application
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
EP: European Pharmacopoeia
ETP: Effluent Treatment Plant
EU: Endotoxin unit
EU: European Union
URS: User Requirement Specification
FAT: Factory Acceptance Testing
SAT : Site Acceptance Test
IQ : Installation Qualification
DQ : Design Qualification
OQ : Operational Qualification
PQ: Performance Qualification
FBD: Fluid-bed dryer
FBP: Fluid-bed Processor
RMG : Rapid mixer Granulator
FDC: Fixed Dose Combination
FEFO: First expiry first out
RA: Regulatory Affairs
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
DOP: Dioctyl Phthalate
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)
HPLC: High performance liquid chromatography
DHS : Dry heat sterilization
HVAC: Heating, ventilating, and air conditioning
ICH: International Conference on Harmonisation
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
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
WL: Warning letter
MOA: Method Of Analysis
MSDS: Material Safety Data Sheets
NCE: New chemical entity
NDA: New Drug Application
NF: National Formulary
NIR: Near Infra Red Spectroscopy
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
PLC: Programmable Logical Control
PVC: Polyvinyl Chloride
PVDC: Polyvinylidene Chloride
PW: Purified Water
QBD : Quality by design
QM: Quality Manual
QMS: Quality Management System
RH: Relative humidity
RLAF: Reverse laminar air flow
RLD: Reference listed drug
RM: Raw material
RM: Packing material
FGS: Finished Goods Store
BSR: Bounded store Room
RO: Reverse Osmosis
RS: Related Substance
SAT: Site Acceptance Testing
SIP: Sterilization in place
SIP: Steam in place
SLS: Sodium Lauryl Sulphate
SMF: Site master file
SOP: Standard operating procedure
SPE: Society for Pharmaceutical Engineering
SUPAC: Scale-up and post approval changes
SVP: Small Volume Parenteral
TDS: Total Dissolved Solids
TOC: Total organic carbon
TSE: Transmissible spongiform encephalopathy
USP: United States Pharmacopoeia
USP-NF: United States Pharmacopoeia-National Formulary
API: Active Pharmaceutical Ingredients
VMP: Validation Master Plan
WFI: Water for injection
TRF : Test Request Form
CFR: Code of Federal Regulations
CFU: Colony Forming Unit
cGMP: Current Good Manufacturing Practices
CIP: Clean in place
COA: Certificate of analysis
MOA: Method of analysis
COS: Certificate of suitability
COPP: Certificate of Pharmaceutical Products
CPP: Critical Process Parameter
DMF: Drug master file
PMPS: Pharmaceutical Manufacturing Process Steps
MFP: Media Filling Process
SFG: Semi Finished Goods
PM: Preventive Maintenance
SFG: Semi Finished Goods
FG: Finished Goods
NPI: New Product Introduction
PDL: Packaging Development Laboratory
Do you know How medicines are manufactured ?
In ancient times people use plants or animals matter to cure some sort of ailment or diseases by using home remedies. But now day’s medicine manufacturing is performed by chemical processing. Learn more about How medicines are manufactured at given below article
