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A platform is the basic hardware and software that allows other applications and technologies to be developed on top of it. There are many types of platforms including operating systems, computing platforms, database platforms, storage platforms, application platforms, mobile platforms, and web platforms. An operating system is system software that manages computer hardware, software resources, and provides common services. It performs functions like process management, memory management, file management, device management, I/O management, and security. Popular operating systems currently include Windows, Android, iOS, Mac OS, and Linux.
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The document discusses platform technology, which is a common or standard method that can be applied across multiple drug products to improve efficiency and quality, and provides examples like nanotechnology, microsphere technology, and liposomal technology. It also outlines the pathway for developing a platform technology, which involves selecting a candidate drug, polymers, and designing the technology, as well as describing the development and manufacturing process. Platform technologies allow companies to streamline drug development and manufacturing.
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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.
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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.
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Licensing is one of those terms that are used quite frequently and hold high importance.
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This document discusses electronic submission of drug applications using the electronic common technical document (eCTD) format. It provides an overview of eCTD, including its module structure and requirements. The key points covered are:
- Regulatory agencies now prefer eCTD format over paper submissions for drug applications due to benefits like reduced storage needs, increased accountability and easier review.
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The document discusses the Certificate of Pharmaceutical Product (CoPP), which is issued by regulatory authorities to help importing countries assess the quality of pharmaceutical products. It outlines the importance of the CoPP for product registration in other countries. The summary also describes the application process for obtaining a CoPP in India, including requirements for documentation, inspections, and the format of the certificate.
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Technology development and transfer industrial pharmacy ll
visit website
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jsmasipharmacy.blogspot.com
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The document discusses key aspects of technology transfer between a sending unit and receiving unit. It defines technology transfer and lists requirements such as a documented approach, trained personnel, and quality documentation. It also defines terms related to quality assurance in technology transfer, including active pharmaceutical ingredients, good manufacturing practices, process validation, and more. Finally, it provides guidance on aspects of technology transfer including developing a transfer protocol, specifications for starting materials, and information that should be transferred about APIs and excipients.
Buccal drug delivery system
I have tried to include almost all details in superficially, and have been supported a lot by my ma'm SHITAL ACHARYA. Thanks to her
Technology Transfer Related Documents.pptx
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.
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technology transfer documents confidentiality agreements, licensing, mous.pdf
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Technology development and transfer industrial pharmacy ll
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Srishti Gupta thanks the Information Technology Training Center and faculty of the Gurugram Branch of NIRC of ICAI for giving her the opportunity to encourage her innovativeness and extra-curricular interests. She also thanks her mentor Ms. Shilpa Kaushik, her parents, and all her friends for their continuous encouragement. The document appears to be Srishti Gupta expressing her gratitude to various organizations and individuals for their support.
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Single-User/Single-Tasking Operating Systems
Single-User/Multitasking Operating Systems
Multi-User/Multitasking Operating Systems
User Interface
Graphical User Interface (GUI)
Command-Line Interface
Running Programs
Managing Hardware
OS.pptx
The document discusses the evolution and functions of operating systems. It describes how operating systems act as an intermediary between the user and computer hardware by managing resources, executing programs, and handling input/output. The key functions of operating systems are process management, memory management, file management, input/output management, and secondary storage management. Operating systems also provide services like program execution, input/output operations, file system manipulation, communications, error detection, resource allocation, accounting, and protection.
Functions Of Operating Systems
The document discusses the functions and types of operating systems. It defines an operating system as the most important program that runs on a computer and performs basic tasks like recognizing input/output and managing files. The major functions of an operating system are providing an interface for users, managing system resources like memory and CPU time, running applications, and handling security and access rights. The document outlines different types of operating systems including real-time, single-user/multi-tasking, multi-user, distributed, and embedded operating systems. Examples of specific operating systems are also provided.
Comp Project (V).pptx
This document provides an overview of computer operating systems. It defines an operating system as the first program that loads when a computer is turned on, acting as an interface between software and hardware. The document then lists key functions of operating systems like processor management, memory management, and file management. It categorizes operating systems as single-user, graphical user interface, multi-user, multithreading, multitasking, real-time, and distributed based on their capabilities. Examples are provided for each category.
systems_software
Computer software refers to a set of instructions given to a computer to perform tasks and comes in two types: systems software and applications software. Systems software includes operating systems, which control computer operations and manage resources, and development programs, which help create application software. Popular operating systems include Windows, Mac OS, Linux, and UNIX.
Basic Software.pptx
Software is a set of instructions, data or programs used to operate computers and execute specific tasks. It is the opposite of hardware, which describes the physical aspects of a computer. Software is a generic term used to refer to applications, scripts and programs that run on a device.
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Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
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Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
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Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
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platform-technologies_compress.pdf
- 2. WHAT IS A PLATFORM? • A platform is a group of technologies that are used as a base upon which other applications, processes or technologies are developed. • In personal computing, a platform is the basic hardware (computer) and software (operating system) on which software applications can be run. • Computers use specific central processing units (CPUs) that are designed to run specific machine language code.
- 3. TYPES OFTECHNOLOGY PLATFORMS 1. Operating systems 2. Computing platforms 3. Database platforms 4. Storage platforms 5. Application platforms 6. Mobile platforms 7. Web platforms
- 4. 8 API Platforms 9. Security 10. Internet ofThings 11. AI platforms 12. Game Platforms
- 5. WHAT IS AN OPERATING SYSTEM? • is system software that manages computer hardware, software resources, and provides common services for computer programs. Ex.Windows, Mac OS, Linux, UNIX, IOS,Android, etc.
- 6. LIST OF OPERATING SYSTEMSWITH THE LATEST MARKETSHARE OS Name Share Windows 40.34 Android 37.95 iOS 15.44 Mac OS 4.34 Linux 0.95 Chrome OS 0.14 Windows Phone OS 0.06
- 7. HISTORY OF OPERATING SYSTEM • Operating systems were first developed in the late 1950s to manage tape storage • The General Motors Research Lab implemented the first OS in the early 1950s for their IBM 701 • In the mid-1960s, operating systems started to use disks • In the late 1960s, the first version of the Unix OS was developed • The first OS built by Microsoft was DOS. It was built in 1981 by purchasing the 86-DOS software from a Seattle company • The present-day popular OS Windows first came to existence in 1985 when a GUI was created and paired with MS-DOS.
- 8. TYPES OF OPERATING SYSTEMS • Batch-Operating System - The user of a batch operating system never directly interacts with the computer. In this type of OS, every user prepares his or her job on an offline device like a punch card and submit it to the computer operator. • SingleTasking - system can only run one program at a time. • Multi-tasking - operating system allows more than one program to be running in concurrency. • Real time OS - A real time operating system time interval to process and respond to inputs is very small. Examples: Military Software Systems, Space Software Systems.
- 9. • Network Operating System - Network Operating System runs on a server. It provides the capability to serve to manage data, user, groups, security, application, and other networking functions. • Mobile OS - Mobile operating systems are those OS which is especially that are designed to power smartphones, tablets, and wearables devices.
- 10. FUNCTIONS OF AN OPERATING SYSTEM • Process Management - Process management helps OS to create and delete processes. It also provides mechanisms for synchronization and communication among processes. • Memory Management - Memory management module performs the task of allocation and de- allocation of memory space to programs in need of this resources. • File Management - It manages all the file-related activities such as organization storage, retrieval, naming, sharing, and protection of files. • Device Management - Device management keeps tracks of all devices.This module also responsible for this task is known as the I/O controller. It also performs the task of allocation and de-allocation of the devices.
- 11. • I/O Management - One of the main objects of any OS is to hide the peculiarities of that hardware devices from the user. • Secondary- Storage Management - Systems have several levels of storage which includes primary storage, secondary storage, and cache storage. Instructions and data must be stored in primary storage or cache so that a running program can reference it. • Security - Security module protects the data and information of a computer system against malware threat and authorized access.
- 12. • Command Interpretation - This module is interpreting commands given by the and acting system resources to process that commands. • Networking - A distributed system is a group of processors which do not share memory, hardware devices, or a clock.The processors communicate with one another through the network. • Communication Management - Coordination and assignment of compilers, interpreters, and another software resource of the various users of the computer systems.