Sunday, August 30, 2015 8:19:56 AM
http://www.prnewswire.com/news-releases/nanoviricides-inc-completes-purchase-of-cgmp-compliant-pilot-production-facility-300017051.html
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Discusses%20the%20Strong%20Effectiveness%20of%20Its%20Anti-Herpes%20Drug%20Candidates%20in%20a%20Lethal%20Animal%20Model%20of%20Dermal%20Herpes%20Infection.html
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Considerations in pilot plant development --
-Kind and size – depends on goals; evaluating product and process; producing samples of product for evaluation; market testing or furnishing to potential customers
-Location: near R&D facility? At an existing plant? Close liaison between R&D and pilot plant staff is essential
-Labor requirements and costs: engineering staff, skilled operations and maintenance staff- pilot plant costs may exceed those of usual plant production costs. The pilot plant may be used for training personnel for a full- scale plant
Objective of scale up --“Find mistakes on small scale and make profit on large scale.”
-To produce physically and chemically stable therapeutic dosage forms.
-Review of the processing equipment.
-Guidelines for productions and process control.
-Evaluation and Validation.
-To identify the critical features of the process. To provide master manufacturing formula.
Pilot plant studies include the close examination of the formula to determine:
-Its ability to withstand batch scale .
-Process modification .
-Compatibility of the equipment with the formulation.
Cost factor.
-Availability of raw materials meeting the specifications required to produce the product.
-Market requirement.
-Physical space required and the layout of the related functions
Thus , during the scale up efforts in the pilot plant:
-Production and process controls are evaluated , validated and finalized.
-Product reprocessing procedures are developed and validated . -Appropriate records and reports are issued to support cGMP
PILOT PLANT DESIGN
A pilot plant design should support three key strategic objectives:
-Formulation and process development.
-Clinical supply manufacture.
-Technology evaluation , scale up and transfer.
Attributes playing a key role in achieving the above objectives are :
-cGMP Compliance.
-A flexible highly trained staff .
-Equipment to support multiple dosage form development . -Equipment at multiple scales based on similar operating principles to those in production .
...
PILOT PLANT OPERATION
Operational Aspects of Pilot Plant includes:
-Validation Training Engineering Support Maintenance Calibration -Material Control Inventory Orders Labeling Process and Manufacturing Activities
-Quality Assurance and Quality Control
VALIDATION:
A validation master plan should be develop that addresses--
-The design specifications Installation qualification
-Operational qualification
-Performance qualification of all major utility systems, process equipment, and computer control systems.
-A fully validated pilot plant should ensure compliance with cGMP and should meet current FDA standards.
TRAINING:
Training in four major area required–-
-Compliance with quality standards such as cGMP Safety and environmental responsibilities
-Compliance with SOPs Technical skills and knowledge
...
MAINTENANCE:
It is required to –-
-Meet cGMP norms
-To ensure data integrity and equipment reliability during the development process.
-The maintenance program should be documented and written procedures established.
CALIBRATION: Calibration of critical instruments/equipments is required for–-
-Compliance with cGMP Maintaining the integrity of data generated during the development process
-Calibration should be performed by well trained and expert staff ...
PROCESS EVALUATION:
-It is the basis of process validation
-Documentation of process is to be done.
-Process is validated only if there are no changes in the formula, quality of the ingredients, or the equipment configuration
-Revalidation needs to be done to ensure that changes have not take place.
GMP CONSIDERATIONS:
GMP Items that should be a part of scale up are --
-Equipment qualification
-Process validation
-Regularly schedule preventive maintenance
-Regularly process review & revalidation
-Relevant written standard operating procedures
-The use of competent technically qualified personel
-Adequate provision for training of personel
-A well-defined technology transfer systemValidated cleaning procedures.
-An orderly arrangement of equipment so as to ease material flow & prevent cross-contamination
http://www.academia.edu/8939649/PILOT_PLANT_SCALE_UP_TECHNIQUES_CONTENTS_INTRODUCTION_ON_PILOT_PLANT_AND_SCALE_UP
Dr. Eugene Seymour clearly stated scale-up studies was a laborious process (paraphrasing) but we are moving forward now with the commissioning of the new state of the art, multi-kilogram Pilot Plant in Shelton, CT to produce FluCide(TM), announced on January 2015.
http://www.pharmamanufacturing.com/articles/2004/41/
Who do you believe, a "Tokyo Rose"-like anonymous poster with many aliases, posting from somewhere in Washington, D.C., New York City - Wall Street, California/Big Pharma office, the Kremlin - Russia, Beijing - China, all trying to scare "longs" out of their wits by using their financial might to drive the nav of NNVC shares to a new low?...or do you believe Dr. Milton Boniuk, an independent director/insider who is buying with great frequency and confidence?
http://ih.advfn.com/p.php?pid=nmona&article=68325023
http://www.streetinsider.com/SEC+Filings/Form+4+NANOVIRICIDES,+INC.+For%3A+Aug+13+Filed+by%3A+BONIUK+MILTON/10843248.html
http://www.nanoviricides.com/press%20releases/2013/NanoViricides%20Appoints%20Baylor%20Professor%20Dr.%20Milton%20Boniuk%20as%20an%20Independent%20Board%20Member.html
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