Tuesday, July 20, 2010

CMO of the Day - Boehringer Ingelheim



I am starting a new Blog attack - one blog post per weekday until I get through the entire list of CMOs on our Biopharma CMO Search Engine, CMOLocator.

My first CMO of the day is Boehringer Ingelheim.


As one of the leading companies for the contract manufacturing of biopharmaceuticals, Boehringer Ingelheim offers the entire production technology chain in development and production at its facilities in Biberach (Germany) and Vienna (Austria). Their large scale manufacturing sites deliver biopharmaceutical products like therapeutic proteins, fusion proteins, protein scaffolds, monoclonal antibodies, antibody mimetics and plasmid DNA.

We have listings for 27 of their production lines on our CMO search engine:

Boehringer Ingelheim Biberach Train 1

Boehringer Ingelheim Biberach Train 2

Boehringer Ingelheim Biberach Train 3

Boehringer Ingelheim Biberach Train 4

Boehringer Ingelheim Biberach Train 5

Boehringer Ingelheim Biberach Train 6

Boehringer Ingelheim Biberach Train 7

Boehringer Ingelheim Vienna Microbial Train 1

Boehringer Ingelheim Vienna Microbial Train 2

Boehringer Ingelheim Vienna Microbial Train 3

Boehringer Ingelheim Vienna Microbial Train 4

Boehringer Ingelheim Vienna Microbial Train 5

Boehringer Ingelheim Vienna Microbial Train 6

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 1

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 2

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 3

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 4

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 5

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 6

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 7

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 8

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 9

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 10

Boehringer Ingelheim Biberach Fill/Finish Line 1

Boehringer Ingelheim Biberach Fill/Finish Line 2

Boehringer Ingelheim Biberach Fill/Finish Line 3

Boehringer Ingelheim Biberach Fill/Finish Line 4

Tuesday, April 20, 2010

cGDP and cGMP Training Packages

Our Introduction to cGDP Current Good Documentation Practices and Introduction to cGMP Current Good Manufacturing Practices Training Packages have been selling very well in the last few months! More and more companies are recognizing the value of using our training packages to get their employees up to speed on GMP and GDP practices in a very efficient, inexpensive way. Why hire an outside consultant to teach you the concepts when you download our training packages at a fraction of the cost?



Our online store offers templates for Pharma, Biotech and Medical Devices, Standard Operating Procedures for things like Riboflavin Coverage Test, Data Recording Standards, pH & Conductivity Meters and many more. We also offer classroom courses in technology transfer for Biopharmaceuticals, and technical presentations on cutting edge topics.

Visit our store at www.kymastore.com today and see how much time you can save on your next project!

Monday, March 29, 2010

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!

Friday, March 26, 2010

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!