Analytical Method Transfer in Technology Transfer (TT) according to WHO guidelines

Learn WHO guidelines for analytical method transfer with SU and RU duties in technology transfer process in industrial pharmacy. Analytical Method Transfer in Technology Transfer (TT) Analytical Method Transfer Protocols This analytical method transfer protocol should contain details of the: Duties of Sending Unit (SU) for the transfer of analytical methods Duties of Receiving Unit … Read more

Difference between qualification and validation

Here is a simplified table highlighting the differences between Qualification and Validation in industrial pharmacy. Difference between qualification and validation Qualification defines as the process of checking and documenting whether equipment, systems or processes meet specific standards and requirements for their intended use. It ensures that everything is up to the necessary standards and functions … Read more

WHO guidelines: Premises and Equipements for Technology Transfer

Learn about WHO guidelines for Premises and Equipements to successful Technology Transfer in Industrial Pharmacy. Why Premises and Equipements are important? Premises and Equipements are vital for technology transfer due to the following reasons: In summary, precise equipment information is crucial for successful technology transfer, ensuring replication, quality control, compliance, process optimization, and efficient maintenance. … Read more

Documentation in Technology Transfer

Learn Documentation in technology transfer in pharmaceutical industry Documentation contains Development Report, Plan and Reports. What is Documentation in Technology Transfer? Documentation in technology transfer refers to the process of capturing and recording essential information, procedures and knowledge related to transferring a technology from one organization to another. Each and every step performed from R&D … Read more

Granularity of Technology Transfer (TT) Process

Learn Granularity of Technology Transfer (TT) Process and the materials such as API, excipients, finished products and packaging procedure. Granularity of Technology Transfer The granularity of technology transfer refers to the level of detail or specificity at which technology is transferred from one entity to another. It refers to the extent to which the knowledge, … Read more

Technology Transfer from R & D to production

Learn Technology Transfer from R & D to production and Technology Transfer Dossier and key aspects like process, packaging and cleaning. What is Technology Transfer Dossier? The Technology Transfer Dossier (TTD) is a crucial document provided by R&D to the product development laboratory. It encompasses key information related to formulation and drug product development. The … Read more

Quality Risk Management in Industrial Pharmacy

Learn definition and principle of Quality Risk Management (QRM) with applications. It helps to control risks in pharmaceutical products. What is Quality Risk Management? Quality risk management is a systematic way to identify, assess and control risks that may affect the quality of pharmaceutical products. It involves evaluating potential risks based on scientific knowledge, protecting … Read more

Technology Transfer Protocol in Industrial Pharmacy

Learn about the key sections and importance of a technology transfer protocol for smooth knowledge transfer between labs. Technology Transfer Protocol Technology transfer protocol is a document create to transfer a technology from one lab to another. Sometimes, if a contract manufacturer or laboratory is involved, they may have their own procedures that need to … Read more

HPLC Column Types Used for analysis

Exploring Different Types of HPLC Column Used for pharmaceutical. The columns help to separates and analyzes complex mixtures. What are Columns in HPLC? In High-Performance Liquid Chromatography (HPLC), a column is a vital component of the chromatographic system. It is a cylindrical tube packed with a stationary phase material that facilitates the separation and analysis … Read more

WHO Guidelines for Technology Transfer in Pharmacy

WHO guidelines for technology transfer in industrial pharmacy. Learn how these guidelines ensure efficient and quality-driven transfers. What is Technolgy transfer in pharmacy? It involves the exchange of knowledge, skills and expertise between organizations. The purpose can be developing, manufacturing or distributing pharmaceutical products. It involves sharing information, intellectual property, manufacturing processes, quality control procedures. … Read more