Pharmaceuticals

This package features 29 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within an organization.

This training package features an Adobe Flash training presentation with audio, which provides a strong tool for training a workforce in the fundamentals of cGMP manufacturing.

This training package features an Adobe Flash training presentation with audio, which provides a strong tool for training a workforce in the fundamentals of current Good Documentation Practices.

This template package features a universal IQ/OQ Protocol template that provides a ready-to-populate document to generate an IQ, OQ, or IOQ in the pharma or biotech industry.

This template package contains our most popular Technology Transfer templates.

This training package features a training presentation which provides an overview of statistical methods and how they can be utilized for validation.

This training package features a training presentation, which provides background and supplemental information on using Project Charters, and a Project Charter template.

This SOP package features an SOP template that provides instructions for the preparation and execution of riboflavin coverage tests in washers and tanks.

This package features a universal audit / inspection preparation checklist template which provides a comprehensive list of tasks and activities that should be performed by multiple departments in preparation for a regulatory inspection or audit.

This template package features a universal Change Management Form Template that provides a method for formally tracking and approving changes in a project which are outside of the approved project charter or project plan.

This template package features a universal Communication Plan Template that provides a method for clearly defining the communication responsibilities, rules, vehicles, and frequency for any project.

This template package features three universal Kickoff Meeting Agenda Templates that provide the tools to effectively facilitate and manage a 2 hour, 4 hour, or 8 hour long Kickoff Meeting for any project.

This template package features a universal Project Closeout Form Template that provides a method for formally closing out a project, including performing a Lessons Learned, Risk Plan review, and project file archival.

This template package features a universal RACI Diagram Template that provides a method for clearly communicating roles and responsibilities on a team during any project.

This package features a standard procedure which outlines the approach for managing risk within any project. Three universal templates to support the creation of a plan for managing risks are also provided.

This template package features a universal Stakeholder Analysis Template that can be used to outline those individuals and/or organizations who may impact or be impacted by a project.

This package features a training presentation that outlines a standard procedure for aseptic gowning, as well as recommended cleanroom behavior for aseptic processing areas.

This training package features a comprehensive introduction to the CAPA (Corrective Action and Preventive Action) process.

This package features a technical presentation which provides an overview of Automated Inline Dilution processes and equipment.

This training package features a technical presentation which provides a comprehensive introduction to process water coolers.

This training package features a technical presentation which provides a comprehensive overview of data logging in FDA regulated industries.

This SOP package features an SOP template that provides a step-by-step procedure and test logs for thermal mapping a pharmaceutical refrigerator.

This template package features two universal meeting agenda and meeting minutes templates that can be used to effectively facilitate and manage any meeting.

This template package features a universal action item list and decision register template that can be used to easily manage tasks and responsibility for any project or meeting.

This template package features a universal Analytical Assay Summary template that can be used to provide the most up-to-date information on all assays used for in-process testing, lot release, characterization, raw material testing, and other assays related to a specific process requiring technology transfer.

This training package features a training presentation which provides background information on microbiology and an overview of aseptic processing in GMP facilities.

This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of micro and ultra-micro analytical balances.

This training package features a training presentation which provides tips and techniques on the art of sales.

This template package features a universal Bill of Materials template that can be used to provide the most complete information on all components, raw materials, consumables, reagents, and biologic materials.

This template package features a universal Biologic Material Transfer Log template that can be used to document the transfer of cells and intermediates in various stages of processing, including purified product and reference standard. The log provides basic information on the origin, nature, and key biological and safety properties of the materials in question.

This SOP package features an SOP template that provides instructions for pre-use cleaning and disinfection, operation, and post cleaning for a Class II, Type B2 biological safety cabinet.

This template package features a universal Certificate of Translation template that can be used to properly document and certify any documents that require translation.

This SOP package features a standard procedure that defines a fully compliant GMP documentation system for any GMP facility.

This SOP package features a standard procedure outlining a completely defined and cGMP compliant training system.

This template package features a universal Change Management template that can be used to provide information on both contemplated and actual modifications to the process and/or its components in a controlled and documented manner.

This training package features a training presentation which provides an overview of cleaning validation in the pharmaceutical and biotech industries.

This SOP package features a standard step-by-step procedure for handling numerical raw data and calculations.

This template package features a universal Equipment List template that can be used to provide the most complete information on all critical and auxiliary systems for the transferred manufacturing process and associated testing.

This SOP package features a comprehensive step-by-step procedure that provides instructions for the construction, installation, and operation of a feed through assembly.

The Kymanox Feed Through Assembly is a cost effective method for inserting thermocouples into pressurized environmental chambers, such as sterilizers.

This rental package provides a cost effective method for inserting thermocouples into pressurized environmental chambers, such as sterilizers.

This template package features a universal Interview Evaluation template that can be used to conduct and rate any interview for potential employment.

This training package features a training presentation that provides an overview of cell culture processes and terminology, including cell culture vs. fermentation, cell lines, manual & automated cell culture, harvest, and cell banking.

This training package features a training presentation which provides training and quality professionals with a strong tool for training their workforce in the basics of validation master plans.

This SOP package features an SOP template that includes detailed instructions for the setup and operation of a PC-controlled, Kaye Validator 2000 system that are not available in the GE Sensing procedures.

This equipment package includes everything needed to perform reliable, highly accurate temperature studies, including a laptop PC and 36 premium thermocouples.

This equipment rental package includes everything needed to perform reliable, highly accurate temperature studies, including a laptop PC, feed through assembly, and 36 premium thermocouples.

Kymanox provides experienced personnel to perform data logging services using the Kaye Validator 2000 to deliver the information that you need.

This template package features a universal material receipt and lot testing template that can be used for receiving raw materials and executing incoming testing.

This SOP package features an SOP template that outlines the procedure for releasing incoming raw materials. A Material Receipt & Lot Testing template form is also provided.

This SOP package features a procedure for effectively planning and facilitating any meeting. Three universal templates to support meeting facilitation are also provided.

This SOP package features an SOP template that provides instructions for the setup, calibration, and operation of a pH/Conductivity Meter.

This SOP package feactures an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical freezer.

This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical incubator.

This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical refrigerator.

This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical ultra-freezer.

This training package features a training presentation which provides training and quality professionals with a strong tool for training their workforce in the basics of post validation monitoring and validation lifecycle management.

This training package features a training presentation that provides an overview of validation and discusses the need for validation, the validation process, and what it means to operate in a state of control.

This template package features a universal Project Charter template with example text that can be used for any project requiring a Project Charter.

This training package features a training presentation which provides a strong introduction and detailed overview to the fundamentals of project management.

This template package features a universal project roster template that includes all of the pertinent information that should be captured in any project roster.

This training package features a training presentation which provides an overview of purification processes and terminology.

This template package features a universal Quality Plan template with example text that can be integrated into any documentation system and used to define the quality practices, resources, and activities relevant to a process.

This template package features a universal Sampling Plan template that can be used to provide information on quantity, size, and nature of samples of materials to be collected at various stages or unit operations for process control, release, or informational purposes. This template is especially useful for technology transfers.

This SOP package features an SOP template that provides instructions for the setup and operation of SmartReader data loggers from ACR Systems.

This template package features a universal Solution Formulation template that can be used to outline the minimum requirements for the successful transfer of information necessary for the preparation of buffers, media, and other solutions.

This template package features a universal SOP template that can be integrated into any documentation system and used for formatting any policy, process, or procedure document.

This SOP package features a procedure that provides comprehensive instructions on creating comprehensive, effective, and clear Standard Operating Procedures in any industry.

This template package features a universal traceability matrix template that provides a ready-to-populate document and spreadsheet to generate a trace matrix for any system validation.

This template package features a universal Training Attendance Sheet template that can be used to properly track and document the attendees of any training course.

This Standard Operating Procedure (SOP) package features a 19 page document which outlines guidelines for transferrring technology for the development or manufacturing of biopharmaceuticals, vaccines, or combination devices.

This Standard Operating Procedure (SOP) package features a 19 page document which outlines guidelines for transferrring technology for the development or manufacturing of biopharmaceuticals, vaccines, or combination devices.

This template package features a comprehensive outline of the information required in a User Requirements Specification for the Biotechnology, Medical Device or Pharmaceutical industries. It includes sections for process overview, design and construction, operational requirements, automation requirements, safety, acceptance and delivery, and documentation. Suggested technical content is also included throughout the template.

This package features a universal Weighted Grid Analysis Tool that provides a method for comparing multiple project options.

This training package features a training presentation which provides basic training for managers and employees on workplace harassment.

This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Plans, which provide information on assays requiring transfer, activities related to assay qualification at the receiver site, as well as expected results and specifications.

This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Reports, which provide documented proof that transferred assays perform at the receiver's facility and in the receiver's hands acceptably and comparably with the sender.

This SOP package features a procedure that provides comprehensive instructions on creating Detailed Process Descriptions, which provide the most up-to-date information on equipment, materials, methods, process steps, and unit operations, as well as specifications for raw materials and components, intermediates, bulk drug substances, and drug product.

This SOP package features a procedure that provides comprehensive instructions on creating Experiment Reports, which document the details of an individual experiment or trial performed as part of a process transfer.

This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Plans, which outline, in detail, the strategies, activities, and timeline for transferring a process between different facilities, as well as provide expected results and specifications for the transfer.

This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Reports, which provide documented proof that a transferred process performs at the receiver’s facility and in the receiver’s hands acceptably and comparably with the sender.

This training package features a training presentation which provides basic training for employees responsible for writing or managing SOP documents.

This training package features a training presentation which provides basic information on the writing and execution of validation protocols.