KymaSTORE - Downloads for Ideal Knowledge Transfer

Buy 2, Get 1 Free Sale while supplies last! Click the link above for more details.

20 pens with black, cGMP-compliant, indelible ink as required by FDA, ICH, FMEA and other regulatory authorities.

$19.80

Blue Retractable GMP Pen (20-pack)

Buy 2, Get 1 Free Sale while supplies last! Click the link above for more details.

20 pens with blue, cGMP-compliant, indelible ink as required by FDA, ICH, FMEA and other regulatory authorities.

$19.80

Regulatory Audit Checklist and Scorecard Template Package

This template package features a comprehensive audit checklist that can be used to perform internal and external audits of facilities following FDA, ISO, & EU regulations.

$400.00

Writing Detailed Process Descriptions Package

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.

$100.00

Riboflavin Coverage Test SOP Template Package

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

$100.00

Universal Technology Transfer SOP

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.

$100.00

Introduction to cGMP Current Good Manufacturing Practices Training Package

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.

$500.00

Introduction to cGDP Current Good Documentation Practices Training Package

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.

$400.00

User Requirements Specification Template Package

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.

$100.00

Traceability Matrix Template Package

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.

$50.00