User:AnandGDeshmukh

AnandGDeshmukh An Industrial Pharmacist. Feels to create an interest in Industrial Pharmacy education and to contribute to Wikifoundation.

Active Pharmaceutical Ingradient (API)Industry
It is generally a chemical industry to produce a certain pure chemical that can be used in pharmaceutical purposes.These Chemical industries need to follow the additional regulations related to medicines and healthcare.

Pharmaceutical Formulations Industry
Formulations are the usable form of pharmaceutically useful material that can be suitably handled during the patient treatment.

Pharmaceutical Formulations Industry for Human use
Human being has been given a highest priority of care and hence special cares are being taken to make medicines used for it. Formulation industry produces different dosage forms that can be used by patients.

Pharmaceutical Formulations Industry for Veterenery use
Considering the dose requirement and suitability of medicine administration it has been made certain requirements applicable to the industry that are making medicines for animals other than Human being.

Pharmaceutical Medical Devices Industry
The certain devices need some care while making useful for the patients are also regulated in the same way that of medicines.

Basic Research studies on New Chemical Entity(NCE)for Pharmaceutical use
New Chemical Entity(NCE) is a chemical substance that hasn't been tried before for medicinal purpose.To ensure it's suitability and use sufficient studies are necessory to perform.

Pre-Clinical and toxicological Studies
These are the studies on animals.It is to ensure effect of medicine.

Clinical Studies
These are the studies on selected human samples.It is to ensure and confirm the effect of medicine in human use.

Pre-formulation Studies
On sucessful pre-clinical and clinical studies API(Active Pharmaceutical Ingradient) has to be converted in suitable user friendly form of medicine and ensure it's physical,chemical and microbiological stability.In order to make API in suitable dosage form it requires additional materials called excipients.This is the study of these related interactions to ensure the potential interactions that would happen in the lifecycle of the dosage form to ensuer the safety,purity and efficacy of the medicine.It includes study of individual components of the dosage form as well as in compound form in different combinations.

Formulation Studies
Once dosage form has been determined and found satisfactory results of pre-formulation studies, actual formulation dosage form need to be studied for its suitable method and manufacturability.

Stability Studies
Established dosage form in formulation development need to be studied to ensure it's physical ,chemical and microbiological stability in it's predetermined form of packaging.It is also a study to establish the shelf life of the formulation.This sucessful data is useful to submit to the licensing authority for medicines.

Scale-up
This is the study conducted to ensure the established required quality parameters and manufacturability that of formulation while changing or scaling up the formulation to the machines, equipments, and methodology used to manufacture it to commercial level at higher volume from small volume at laboratory level.

Technology Transfer
This is a systematic approach to transfer the process information from development to commercial level and need a qualification.

Operations
This is a technical portion of the Pharmaceutical Industry that does all required things to convert components to make it useful for Pharmaceutical purpose.

Manufacturing
This is converting the components to the final useful form.

Factory Layouts
These are the drawings depicting details about the premises and manufacturing facilities and thier respective locations with one another.

Facility and Equipments
It includes premises,building,equipment and machineries that are directly or indirectly useful for the manufacturing and packing.

Capacity
Machine Capacity is the ability of a machine to produce certain quantum of good output at a point before risk point.It can also be expressed in terms of efficiency.Generally manufacturers of the machine claim minimum and maximum capacity or speed with or without load. In case of group of machines,having least is the capacity. Protective capacity is the best concept for routine monitoring.

Packaging
Packaging has been evolved as a special science and art as well keeping in view the product,transportation,storage and customer.In case of pharmaceuticals, stability of the product to maintain its safety and efficacy is the main focus while designing a pack.

Quality Control
Quality control deals with sampling,testing and approvals.

Quality assurance
Quality assurance is a technical administration department.

Documentation
Considering a potential risk in case of unintentional failures documentation of each and every possible aspect is a recommnded control to investigate.

Calibration
To ensure the correction factor in Measuring devices used with respect to that of standard instruments maintained at approved laboratories at standard conditions.

Qualification
Formal documented evidence of acceptability to have predetermined characteristics.

Validation
Formal documented evidence to show the consistent predetermined end result.

Warehousing
Warehousing is a temporary storage of approved Finished Goods (FG) before distribution. It can vary according to the need of the industry.

Engineering and Utilities
It ensures,supports and maintains the facility and equipments in a good working state of condition.

Distribution and Logistics
It includes all the means of transfering the Finished Goods from warehouse to the end customer.

Planning
It is the supporting section of the industry for the best possible execution of the operations.

Demand Planning
It ensures and communicate the customer orders.

Supply Planning
It ensures and communicate the deliveries of the customer orders.

Capacity Planning
It ensures the operational capacities to satisfy the customer needs.It can have forecast or actual demand as a basis to consider. 1.Lead - liberal. 2.Lag  - conservative. 3.Match - balanced.

Marketing
It deals with the essential of industry to find a customer to sustain and grow.

Sales
It deals with the transfering ownership of Finished Goods to customer.Physician is a prescriber to the patient,the medicine sales and sales promotion has a peculiarity of it's kind.

Licencing and Regulations
Pharmaceutical industry is said to be highly regulated considering the health of society.

e CTD
Advantage of technology has made it possible to submit the document in electronic form.

USFDA
The United States of America has control on medicines through Food and drug administrations.FDA Approval is must to market the drug in US.

MHRA
Europe has control on medicines through the Agency MHRA.

TGA
Australia has control on medicines through the Agency TGA.

GxP(Good X Practices)
Being a highly regulated industry it is expected to follow the standard practices at all possible levels hence comprehensive term GxP.X stands for any title that can be fixed for the major category of practices having many activities under its umbrella that can be separated from other titles.

GLP(Good Laboratory Practices)
Testing facility can be called as Laboratory.The way it shall work is said to be GLP.

GCP (Good Clinical Practices)
Study of a drug-body interation on Human object is called Clinical Study.The prescribed way for the safety of the subjects is called GCP, the way to conduct this study.

GMP and cGMP(current Good manufacturing Practices)
The guidelines for manufacturing by the drug controlling authority for its purity,safety and efficacy is GMP.

GEP(Good Engineering Practices)
Machines that are used for medicine making also need preventive and breakdown maintenance. This should have almost negiligible or no impact on the safety, quality and efficacy of the product being manufactured during it.Hence the ways of engineering that cares it can be comprehensively called as Good engineering practices.

Manufacturing and Packaging of Parenterals
Para Enteron made the term parenterals,hence medicines that need route of administration to the patient other than Gastro intestinal (GI)Tract comes under this category.

Manufacturing and Packaging of Opthalmic Preparations
Occular route has been prooved potentially useful in drug delivery. Eye is a delicate organ hence all medicinal preparations administred through this route need to be manufactured according to the highest possible care as that of for parenterals.

Manufacturing and Packaging of Solid Dosage Forms
Formulations in the solid form have some advantages and disadvantages.

Manufacturing and Packaging of Semisolid Dosage Forms
Formulations in the semisolid form have some advantages and disadvantages.

Manufacturing and Packaging of Liquid Dosage Forms
Formulations in the liquid form have some advantages and disadvantages.