Regulatory Audit Checklist

Our fantastic regulatory audit checklist and scorecard is on sale for $300 (a savings of $100) for the remainder of this week.

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

If you are working on a biotech, pharmaceutical or medical device regulatory audit, this checklist provides the following:

• The checklist can be utilized to complete internal or external audits of licensed facilities which are required to follow the ISO, FDA, and EU regulations outlined in the document.
• The checklist is broken into 21 independent audit elements (each with its own tab in the spreadsheet).
• Each element contains a series of questions that correspond to and are cross-referenced by several well-known regulations.
• Each question is assigned a weight, from "Minor" to "Critical", which corresponds to the relative significance of the question and the subsequent requirements. The higher the number, the higher the significance.
• Guide Notes are provided to ensure that the user of the checklist has relevant examples of the regulatory requirement.
• The user of the checklist completes each audit element by filling out the scores for the 21 elements. The user will score the auditee for each question, providing a numerical value equal to the weight when the auditee has shown evidence of meeting the full intent of the regulatory requirement. The user will subsequently record scores based on the responses, down to a zero(0) if the auditee is not meeting the intent of the regulation.
• Upon completion of the checklist, it is recommended that the user capture objective evidence for each question.
• After each element and its subsequent questions have been answered, a total score will be updated automatically at the bottom of the list of questions and in the Summary tab for the evaluation.
• The total score is calculated automatically and provides the facility with a quantitative evaluation of how well it is meeting the regulatory requirements included in the 21 elements. The user may then set an acceptable or "passing" grade for the audit based on the results.
• This audit checklist will serve as an excellent basis for an internal or external audit process.

Save $100 on our Audit Checklist now!

Installation Qualification Template at KymaSTORE

Hi,

I'm excited to say that our Universal Installation Qualification / Operational Qualification (IQ/OQ) Template is now one of our top sellers on our KymaSTORE.



This template provides a universal Installation Qualification/Operational Qualification (IQ/OQ) Protocol template, in a fully editable Microsoft Word document with example text, that can be used to generate IQ, OQ, and IOQ protocols as well as adapted for many other protocols.

It includes all types of data and tests that are expected to be captured to achieve regulatory compliance for FDA, ISO, & EU regulations.

Visit our store and use the coupon code "ITandMarketing" to receive a 10% off discount on any download!

More New Biologics CMOs on CMOLocator!

At Kymanox, we're quite excited about all of the Contract Manufacturing Organizations that are joining our Biologics CMO Search Engine.

Here's a list of the most recently added partners:

AAIPharma Services Corp.

Althea Technologies, Inc

Avecia

Cytovance Biologics, LLC.

Enzon Pharmaceuticals

Eurogentec Biologics

Formatech, Inc.

Goodwin Biotechnology, Inc.

Hyaluron Contract Manufacturing (HCM)

Miltenyi Bioprocess

Novozymes

PacificGMP

Paragon Bioservices, Inc.

Pyramid Laboratories, Inc.

Vivante GMP Solutions, Inc.

CMOLocator (Part III)

I wanted to post an update on the latest Organizations to join our new Biopharma CMO Search Engine:

NEW ACTIVE PARTNERS:

AERAS

Charles River

Eden Biodesign

Florida Biologix

Goodwin Biotechnology, Inc.

Hyaluron Contract Manufacturing (HCM)

Omnia Biologics

Pyramid Laboratories, Inc.

University of Maryland Biotechnology Institute

Thank you to all of the organizations above for helping to grow our search engine.

In addition to our Active partners, we have a number of "CMOLocator Added" partners. These are partners with whom we have worked in the past, and have knowledge of their production lines.

NEW CMOLOCATOR ADDED PARTNERS:

Althea Technologies, Inc.

Avecia Biotechnology Inc.

Avid Bioservices, Inc.

CMC Icos Biologics

Diosynth Biotechnology

DSM

KBI Biopharma

Lonza

Rentschler Biotechnologie

Please visit CMOLocator.com for more information about our Biopharma CMO Listing and Search Engine.

CMOLocator (Part II)

Well, CMOLocator is a hit. In the past two weeks we have had visitors from Italy, Denmark, Netherlands, Belgium, the UK, Spain and over 200 visitors from the US. Decent traffic for a brand new site!



We hope you will visit us too - CMOLocator is the hottest new biopharma website on the internet. Our new Biopharma CMO Search Engine is certain to grow and we are excited about what it can do for Biopharma Contract Manufacturing, as well as for our company, Kymanox. Please take a moment to visit our CMO Search Engine today.

CMO Locator

It's been a while since I've posted, and that is because I have been hidden away working on the very latest Kymanox product, CMO Locator.



CMO Locator is a free search engine specifically designed to help you find Biopharma Contract Manufacturing Organizations that are able to manufacture the Drug Product (API) or Drug Substance (Fill/Finish) that your biotech drug development process requires.

Recently we spent a good deal of time looking for a search engine that would help us identify the best CMO with the right capabilities for the drug development project of a large client. We realized that this search required far too much time and effort to even get to a "short list" of possible candidates. Since there wasn't a good search engine out there, we decided to build one! As a result, we are currently compiling a list of all of the production lines and capabilities of all of the Contract Manufacturing Organizations that we have come in contact with.



Our CMO Search Engine contains the following search options for Drug Substance (API):

Platform: Cell Culture, Microbial
Reactor Scale: 1-100L, 100L-2000L, 2000L-5000L, 5000L +
Bioreactor Process: Batch, Fed-Batch, Perfusion
Compliance Level: Phase I/II, Phase III, Commercial
Biosafety Level: BSL 1, BSL 2, BSL 3, BSL 4
Additional Services: Analytical Services, Cell Banking, Cell Line Development, Preclinical Manufacturing, Process Development, Viral Manufacturing
Regions: Asia, Europe, North America, South America, Australia/New Zealand

For Drug Product (Fill/Finish), you can search on:

Dosage Form: Liquid, Lyophilized
Batch Size: 1-5000, 5000-20000, 20000-50000, 50000+
Vial Size: 2ml, 3ml, 5ml, 10ml, 20ml, 20+ ml
Compliance Level: Phase I/II, Phase III, Commercial
Biosafety Level: BSL 1, BSL 2, BSL 3, BSL 4
Additional Services: Analytical Services, Formulation Development, Preclinical Manufacturing, Prefilled Syringes, Stability Studies, Viral Manufacturing
Regions: Asia, Europe, North America, South America, Australia/New Zealand

If you own or represent a CMO, please follow this link to add or request access to your CMO profile (it's free for base level "Active" listings):

Add your CMO to CMO Locator

We at Kymanox are very excited about this new Biopharma CMO search engine and are striving to make it the only place to come on the web to find your next CMO. We hope it will serve the biopharma industry well.

Universal Technology Transfer

Kymanox has created a set of Universal Technology Transfer Templates available from our KymaSTORE.™ Take a look at our offerings:

• Analytical Assay Summary Template - 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.



• Bill of Materials Template - 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.



• Biologic Material Transfer Log Template - 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.



• Change Management Template - 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.



• Equipment List Template - 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.



• Sampling Plan Template - 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.



• Solution Formulation Template - 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.



• Writing Assay Transfer Plans Procedure - 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. The procedure also includes appropriate example tables to provide further guidance on creating the document.



• Writing Assay Transfer Reports Procedure - 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. The reports summarize the results of executed qualification protocols for each transferred assay.



• Writing Detailed Process Descriptions Procedure - 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. The procedure also includes appropriate example tables to provide further guidance on creating the document.



• Writing Experiment Reports Procedure - 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. Experiment Reports provide the rationale for performing the experiment, as well as a brief description of materials, equipment, procedure, results, and conclusions.



• Writing Process Transfer Plans Procedure - 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. The procedure also includes appropriate example tables to provide further guidance on creating the document.



• Writing Process Transfer Reports Procedure - 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. The report summarizes the results of bench-top verification experiments, process scale-up, and optimization, as well as the Engineering Run at scale.