Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Approaches Of Gastro-Retentive Drug Delivery System or GRDDSAkshayPatane
Approaches Of Gastro-Retentive Drug Delivery System
Includes:
Floating and Non-Floating drug delivery system with their subtypes
Like Non-effervescent system, Effervescent system, Raft forming system,
High Density system, Expandable system, Muco-adhesive system,
Super porous hydrogel system and Magnetic Systems, etc.
Application Of Polymer In Controlled Release FormulationAnindya Jana
Polymers are becoming increasingly important in the field of drug delivery. The pharmaceutical applications of polymers range from their use as binders in tablets to viscosity and flow controlling agents in liquids, suspensions and emulsions. Polymers can be used as film coatings to disguise the unpleasant taste of a drug, to enhance drug stability and to modify drug release characteristics.
As a consequence, increasing attention has been focused on methods of giving drugs continually for a prolonged time periods and in a controlled fashion.
This technology now spans many fields and includes pharmaceutical, food and agricultural applications, pesticides, cosmetics, and household products.
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Approaches Of Gastro-Retentive Drug Delivery System or GRDDSAkshayPatane
Approaches Of Gastro-Retentive Drug Delivery System
Includes:
Floating and Non-Floating drug delivery system with their subtypes
Like Non-effervescent system, Effervescent system, Raft forming system,
High Density system, Expandable system, Muco-adhesive system,
Super porous hydrogel system and Magnetic Systems, etc.
Application Of Polymer In Controlled Release FormulationAnindya Jana
Polymers are becoming increasingly important in the field of drug delivery. The pharmaceutical applications of polymers range from their use as binders in tablets to viscosity and flow controlling agents in liquids, suspensions and emulsions. Polymers can be used as film coatings to disguise the unpleasant taste of a drug, to enhance drug stability and to modify drug release characteristics.
As a consequence, increasing attention has been focused on methods of giving drugs continually for a prolonged time periods and in a controlled fashion.
This technology now spans many fields and includes pharmaceutical, food and agricultural applications, pesticides, cosmetics, and household products.
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging, and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT-related documentation - confidentiality agreement, licensing, MoUs, legal issues
Mucoadhesive drug delivery system interact with the mucus layer covering the mucosal epithelial surface, & mucin molecules & increase the residence time of the dosage form at the site of the absorption.
Mucoadhesive drug delivery system is a part of controlled delivery system.
Since the early 1980,the concept of Mucoadhesion has gained considerable interest in pharmaceutical technology.
combine mucoadhesive with enzyme inhibitory & penetration enhancer properties & improve the patient complaince.
MDDS have been devloped for buccal ,nasal,rectal &vaginal routes for both systemic & local effects.
Hydrophilic high mol. wt. such as peptides that cannot be administered & poor absorption ,then MDDS is best choice.
Mucoadhesiveinner layers called mucosa inner epithelial cell lining is covered with viscoelasticfluid
Composed of water and mucin.
Thickness varies from 40 μm to 300 μm
General composition of mucus
Water…………………………………..95%
Glycoproteinsand lipids……………..0.5-5%
Mineral salts……………………………1%
Free proteins…………………………..0.5-1%
The mechanism responsible in the formation of mucoadhesive bond
Step 1 : Wetting and swelling of the polymer(contact stage)
Step 2 : Interpenetration between the polymer chains and the mucosal membrane
Step 3 : Formation of bonds between the entangled chains (both known as consolidation stage)
Electronic theory
Wetting theory
Adsorption theory
Diffusion theory
Fracture theory
Advantages over other controlled oral controlled release systems by virtue of prolongation of residence of drug in GIT.
Targeting & localization of the dosage form at a specific site
-Painless administration.
-Low enzymatic activity & avoid of first pass metabolism
If MDDS are adhere too tightlgy because it is undesirable to exert too much force to remove the formulation after use,otherwise the mucosa could be injured.
-Some patient suffers unpleasent feeling.
-Unfortunately ,the lack of standardized techniques often leads to unclear results.
-costly drug delivery system
Technology Transfer Related Documents.pptxAfroj Shaikh
SlideShare Description: Technology Transfer Related Documents
Welcome to SlideShare's collection of technology transfer related documents in the field of pharmacy. This presentation focuses on the essential documentation needed for successful technology transfer in pharmaceutical manufacturing, emphasizing its role in ensuring quality, safety, and regulatory compliance.
Technology transfer plays a crucial role in the dynamic and ever-evolving field of pharmacy. It facilitates the smooth transfer of knowledge, processes, and technologies from research and development to commercial production. To ensure a seamless transition, a well-defined set of documents is required to capture critical information, procedures, and controls.
This SlideShare presentation explores the key documents involved in technology transfer within the pharmaceutical industry. The technology transfer protocol is discussed first, highlighting its purpose, contents, and significance. Acting as a roadmap, this protocol outlines the transfer scope, stakeholder responsibilities, timelines, and acceptance criteria, promoting effective communication and collaboration between the sending and receiving units.
The importance of comprehensive process descriptions is also emphasized. These documents detail the manufacturing process, equipment specifications, critical parameters, and in-process controls. They serve as a guide for the receiving unit to replicate the process accurately, ensuring consistent product quality and performance.
Validation and qualification protocols are addressed as well, highlighting their role in verifying that equipment, processes, and systems are suitable for their intended use. These protocols are crucial for meeting regulatory requirements and mitigating risks associated with the transfer.
Analytical method transfer documents are discussed next, encompassing the procedures for transferring and validating analytical methods used to assess the quality attributes of pharmaceutical products. Robust analytical methods are essential to ensure accurate and reliable test results throughout the product lifecycle.
The presentation also covers documentation related to training, risk assessments, change control, and deviation management. These documents help establish a robust quality management system, ensuring adherence to regulatory standards and facilitating continuous improvement.
Whether you're involved in technology transfer, quality assurance, or regulatory affairs, this SlideShare is a valuable resource for understanding the essential documents involved in successful technology transfer within the pharmaceutical industry. By leveraging these documents effectively, you can ensure a seamless transfer process, maintain product quality, and uphold patient safety.
Explore our SlideShare and gain the knowledge necessary to navigate the intricacies of technology transfer in pharmacy. Stay updated with the latest best practices and regulatory guidelines.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging, and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT-related documentation - confidentiality agreement, licensing, MoUs, legal issues
Mucoadhesive drug delivery system interact with the mucus layer covering the mucosal epithelial surface, & mucin molecules & increase the residence time of the dosage form at the site of the absorption.
Mucoadhesive drug delivery system is a part of controlled delivery system.
Since the early 1980,the concept of Mucoadhesion has gained considerable interest in pharmaceutical technology.
combine mucoadhesive with enzyme inhibitory & penetration enhancer properties & improve the patient complaince.
MDDS have been devloped for buccal ,nasal,rectal &vaginal routes for both systemic & local effects.
Hydrophilic high mol. wt. such as peptides that cannot be administered & poor absorption ,then MDDS is best choice.
Mucoadhesiveinner layers called mucosa inner epithelial cell lining is covered with viscoelasticfluid
Composed of water and mucin.
Thickness varies from 40 μm to 300 μm
General composition of mucus
Water…………………………………..95%
Glycoproteinsand lipids……………..0.5-5%
Mineral salts……………………………1%
Free proteins…………………………..0.5-1%
The mechanism responsible in the formation of mucoadhesive bond
Step 1 : Wetting and swelling of the polymer(contact stage)
Step 2 : Interpenetration between the polymer chains and the mucosal membrane
Step 3 : Formation of bonds between the entangled chains (both known as consolidation stage)
Electronic theory
Wetting theory
Adsorption theory
Diffusion theory
Fracture theory
Advantages over other controlled oral controlled release systems by virtue of prolongation of residence of drug in GIT.
Targeting & localization of the dosage form at a specific site
-Painless administration.
-Low enzymatic activity & avoid of first pass metabolism
If MDDS are adhere too tightlgy because it is undesirable to exert too much force to remove the formulation after use,otherwise the mucosa could be injured.
-Some patient suffers unpleasent feeling.
-Unfortunately ,the lack of standardized techniques often leads to unclear results.
-costly drug delivery system
Technology Transfer Related Documents.pptxAfroj Shaikh
SlideShare Description: Technology Transfer Related Documents
Welcome to SlideShare's collection of technology transfer related documents in the field of pharmacy. This presentation focuses on the essential documentation needed for successful technology transfer in pharmaceutical manufacturing, emphasizing its role in ensuring quality, safety, and regulatory compliance.
Technology transfer plays a crucial role in the dynamic and ever-evolving field of pharmacy. It facilitates the smooth transfer of knowledge, processes, and technologies from research and development to commercial production. To ensure a seamless transition, a well-defined set of documents is required to capture critical information, procedures, and controls.
This SlideShare presentation explores the key documents involved in technology transfer within the pharmaceutical industry. The technology transfer protocol is discussed first, highlighting its purpose, contents, and significance. Acting as a roadmap, this protocol outlines the transfer scope, stakeholder responsibilities, timelines, and acceptance criteria, promoting effective communication and collaboration between the sending and receiving units.
The importance of comprehensive process descriptions is also emphasized. These documents detail the manufacturing process, equipment specifications, critical parameters, and in-process controls. They serve as a guide for the receiving unit to replicate the process accurately, ensuring consistent product quality and performance.
Validation and qualification protocols are addressed as well, highlighting their role in verifying that equipment, processes, and systems are suitable for their intended use. These protocols are crucial for meeting regulatory requirements and mitigating risks associated with the transfer.
Analytical method transfer documents are discussed next, encompassing the procedures for transferring and validating analytical methods used to assess the quality attributes of pharmaceutical products. Robust analytical methods are essential to ensure accurate and reliable test results throughout the product lifecycle.
The presentation also covers documentation related to training, risk assessments, change control, and deviation management. These documents help establish a robust quality management system, ensuring adherence to regulatory standards and facilitating continuous improvement.
Whether you're involved in technology transfer, quality assurance, or regulatory affairs, this SlideShare is a valuable resource for understanding the essential documents involved in successful technology transfer within the pharmaceutical industry. By leveraging these documents effectively, you can ensure a seamless transfer process, maintain product quality, and uphold patient safety.
Explore our SlideShare and gain the knowledge necessary to navigate the intricacies of technology transfer in pharmacy. Stay updated with the latest best practices and regulatory guidelines.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The uploaded Power point presentation is of Industrial Pharmacy-II Unit-I (Topic - Pilot Plant Scale up Techniques). ppt is very useful for student of B.pharmacy
Important for D. Pharmacy, B. Pharmacy and M. Pharmacy.
A brief introduction to the basic of pilot plant scale up and its objectives, significance, applications and importance
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Overview on Edible Vaccine: Pros & Cons with Mechanism
Pilot plant Scale Up Techniques: General considerations
1. PILOT PLANT SCALE UP TECHNIQUES:
GENERAL CONSIDERATION
Dr. Mahesh Kumar Kataria
Professor and Head, Department of Pharmaceutics,
Seth G. L. Bihani S. D. College of Technical
Education, Sri Ganganagar
Email: kataria.pharmacy@gmail.com
Dr. Mahesh Kumar Kataria 1
2. GENERAL CONSIDERATIONS OR REQUIREMENTS
DURING PILOT SCALE UP
To have an intermediate batch scale representing procedures
used for commercial manufacturing, generally the following
should be considered.
Dr. Mahesh Kumar Kataria 2
3. 1. Reporting responsibilities
• Adequate records & reporting arrangement.
• Pilot plant functions can be part of the R&D groups with
separate staffing.
• The formulator who developed the product can take it into
the production and continuously provide support even after
the transition into production.
• Separate pilot plant and technical service group.
• Good relationship & effective communication between the
pilot plant group and the other groups like R &D, processing,
packaging, engineering, QA/ QC and marketing.
Dr. Mahesh Kumar Kataria 3
4. 2. Personnel Requirement
SIGNIFICANCE OF PERSONNEL
• Scientists experience in pilot plant, actual production, R&D,
formulation and QC.
• Knowledge about physical & chemical properties of material
and its stability in various dosage form are important.
Scientist should have;
• Good theoretical knowledge about formulations & practical
experience in pharm. industry.
• Capable of understanding objectives of formulator and
production personnel.
• Engineering knowledge as well as scale up.
• Appropriate qualification according to the responsibility.
• Ability to communicate well, develop and maintain good
relationship with other personnel involved in scale up.
Dr. Mahesh Kumar Kataria 4
5. 3. Space Requirements
SIGNIFICANCE OF SPACE REQUIREMENTS
The space requirements of a pilot plant are of four types:
a. Administrative and information processing
• Adequate office & desk space for both the scientists and
technicians to facilitate proper documentation of their
activities and observations with adequate computers.
• Space adjacent to the actual working area with sufficient
isolation to avoid any hindrances in the smooth functioning.
b. Physical Testing Area
• Adequate working area for analysis and physical testing.
• In process quality control (IPQC) helps in early
identification of production and other type of errors.
• Area should provide permanent bench top space for
routinely used physical testing equipment like balances, pH
meters, viscometers, disintegration apparatus, IR moisture
balance etc.
Dr. Mahesh Kumar Kataria 5
6. ….cont…
c. Standard pilot plant equipment floor space
• Specific floor space for different equipments required.
• Should be as per production line of different dosage forms
• Should also be utilized in an effective way.
• Equipment used should be preferably portable.
• Space for cleaning of the equipment.
d. Storage Area
• As per GMP two separate storage areas-
Approved (for API) and Unapproved area (Excipients)
• Different storage area for in-process materials, finished bulk
products from pilot plant, packaging materials & materials
from experimental scale-up batches made in production.
• Controlled environment space for storage of stability samples.
• Storage area for packaging materials.
Dr. Mahesh Kumar Kataria 6
7. 4. Review of the formula:
• Close examination of formula to determine its ability to
withstand batch-scale and process modifications.
• Each aspect require thorough review about the role of each
ingredient and its contribution to final product
manufactured on the small-scale laboratory.
• Important to understand the effect of scale-up process
using different size of equipment that may subject the
product to different types and degrees of stresses which
affect the predetermined quality & specifications of final
product.
• By reviewing the formula, it can be more readily predicted
or recognized all the characteristics related to final
formulation.
Dr. Mahesh Kumar Kataria 7
8. 5. Raw Materials
SIGNIFICANE OF RAW MATERIALS
• Material (API, excipients etc.) for processing in pilot plant may
not be approved and validated.
• Materials should meet up with rising needs of the product.
• As the batch size increases the variations in micrometrics
properties of powder ingredients like particle size, shape, or
morphology may resulting in differences in density, static
charges, rate of solubility, flow properties and different
handling properties of active/inert ingredients.
• Approval & validation is the responsibility of pilot-plant.
• Single supplier may create problem with respect to price &
quality of material so must have alternative suppliers .
Dr. Mahesh Kumar Kataria 8
9. 6. Relevant Processing Equipment
• Economical, simplest & efficient equipment capable
of producing product within the proposed specifications are
considered for scale up process.
• Size of euipments optimum-Too small euipments, the process
developed will not scale up, whereas if too big then the
wastage of active ingredients.
• The ease of cleaning should be considered.
7. Production Rates
All parameters should be considered during scale up to decide
production rate. The production rate depends upon;
• Type of process and equipment
• The immediate and future demand of product.
• Product loss in equipment
• Time required to clean-up equipment between batches
• Numbers of batches.
Dr. Mahesh Kumar Kataria 9
10. 8. Process Evaluation
• The knowledge of the effects of various process parameters
required for optimization and validation of process.
• Optimization performed by monitoring within batch
variation of measurable parameters like content uniformity,
moisture content, weight variation and compressibility.
Dr. Mahesh Kumar Kataria 10
11. 9. Preparation of Master Manufacturing Procedure
Manufacturing procedures should be presented for easy
compliance & understanding for the technicians.
The process directions should be;
• Specific & unambiguous in form of SOPs.
• The weight sheet should clearly identify the chemicals, their
quantities and order in which use.
• Provide sampling plan and procedure viz. time of sampling,
method of sampling and storage of samples.
• In-process specifications like addition rates, mixing time,
mixing speed, heating and cooling rates, drying temp. etc.
and finished product specifications.
Proper documentation should be carried out during process.
Dr. Mahesh Kumar Kataria 11
12. 10. Product stability and uniformity
• Each pilot batch should be studied for stability and uniformity of
content as per the primary objective of the pilot plant.
11. Good Manufacturing Practice (GMP) Considerations
• Compliance of cGMP guidelines is enforced by the FDA during new
product or process development.
Guidelines provide guidance for manufacturing, testing and QA;
• To ensure the safety and consistent quality of finished product.
• Clean & hygienic area, controlled environmental conditions to
prevent cross contamination, validation of critical process,
controlled & clearly defined manufacturing process, qualification &
training of personnel, documented procedures in the form of
SOPs, MFR, batch processing records (BPR), site master file (SMF)
• Emphasize on equipment qualification, regular process review and
revalidation, a well-defined technology transfer system, validated
cleaning procedures and regularly scheduled preventive
maintenance of facilities.
Dr. Mahesh Kumar Kataria 12
13. 12. Transfer of Analytical Methods to Quality Assurance
• Analytical test methods developed at laboratory scale must
be transferred to the QA department.
• The QA personnel responsible for review the process to
make sure that proper analytical instrument is available,
trained personal perform the test, reliability of the test and
review of assay procedure before transfer.
• QA will ultimately be responsible for the release of the
product for either clinical studies or commercialization.
• QA must be accounted for design of the facility like testing
areas, proper product containment areas (quarantine),
work-in-process (WIP) areas as well as released material
areas. Dr. Mahesh Kumar Kataria 13
