Kymanox Midwest Business Development

Greetings and salutations!

On Friday, 21 August I will be attending the 5th Annual Golf Outing hosted by the PDA (Parenteral Drug Association) Midwest Chapter at Chevy Chase Country Club in Wheeling, IL. Last year was very enjoyable and hope the same for this year.

11:00 am - Check in and Lunch begins

12:00 pm - Shotgun (Best Ball) begins

~4:00 pm - Award ceremonies and cocktails

Kymanox is sponsoring the event and we are expecting a great turnout. Several members from our midwest office will be in attendance including myself, Kevin Brown, and Alyson Stevans.

So if you have not already signed up for the event, please do so. I look forward to seeing you there!

Best regards,

Justin Pawlik

Kymanox 5th Year Anniversary

Today, 03AUG09, Kymanox celebrates our 5th year anniversary!

Kymanox (ki'-mah-noks') is committed to delivering Ideal Knowledge Transfer™ to its clients. A variety of services are available, such as technical project management, process operations, and engineering for the biotech, pharmaceutical and life science industries.

We also offer a variety of products available for download from our KymaSTORE™ website - templates, training packages, procedures, equipment packages, and more. Click the logo below to see what KymaSTORE can offer your company.
Ideal Knowledge Transfer Tip:

Perfecting the last 1 to 10% of an individual task may take a disproportionate amount of time and resources and usually does not provide a positive overall return. Instead of perfection, strive towards a state of overall robustness where multiple strategies help ensure the desired outcome.

Training: Universal Technology Transfer Methodologies for Biopharmaceuticals

Stephen M. Perry, PMP and Vladimir Kostyukovsky, Ph.D. of Kymanox will be teaching the course next week, July 27-28, 2009, 8:30 AM – 4:30 PM at NC State BTEC.


The Midwest office is excited to see another round of training coming up at BTEC and know how value-added the training will be for all who attend.







Universal Technology Transfer Methodologies for Biopharmaceuticals Course Description:

Discover how to set-up a team of professionals essential for the success of tech transfer. Assess feasibility, business, and regulatory impact. Identify necessary actions and create detailed assay and process transfer plans. Monitor, evaluate progress, and manage proactively the ongoing technology transfer project. Define criteria and document success of the technology transfer. Defend the rationale for and the outcome of the transfer in front of US and international regulatory bodies.


Best regards,


Justin Pawlik

Project Management in Drug Development: Phase III to Commercialization and Beyond

I attended the two day training last week from 20JUL09 - 21 JUL09 provided by Stephen M. Perry, President of Kymanox at NC State BTEC and was extremely impressed. The course was yet another example of how Kymanox provides Ideal Knowledge Transfer (IKT).

As a new drug candidate enters late‐stage clinical development, project managers must shift their focus from development to preparing to enter the marketplace. A few of the challenges associated with Phase III and Commercialization include regulatory submission, manufacturing scale‐up, and promotional launch. In order to successfully transfer from Phase III to Commercialization, project managers must learn how to apply the fundamentals of cross‐functional project management to these later stages of drug development. Particular skills are needed to effectively implement, monitor, and control late stage projects. By following the procedures and using the tools and templates provided, this course will allow you to successfully manage late‐stage drug development projects and avoid costly delays during the shift from Phase III to Commercialization.

The course was intense and very informative. Upon completion I was able to:

• Select the right cross‐functional team to ensure project success


• Effectively communicate with internal and external stakeholders and prevent communication breakdowns


• Develop useful project objectives and project plans


• Apply risk management strategies when developing project objectives and making risk‐based decisions


• Create and manage an achievable timeline and budget


• Successfully transition from Phase III to commercialization and avoid costly delays

I definitely recommend the training and am looking forward to the next topic on Universal Technology Transfer Methodologies for Biopharmaceuticals which will also be at BTEC on 27-28JUL09.


Please feel free to contact me with any additions, comments, or questions.


Best regards,

Justin Pawlik

GMPPENS | cGMP Compliant Indelible Ink

There has been quite a bit of buzz surrounding GMP pens lately. Companies are looking for a way to easily identify and use pens that are GMP compliant. This saves time and money by reducing the amount of exception reports caused by improper documentation techniques. Kymanox offers a solution... GMPPENS!



One concern that comes up regularly is indelible ink and the resistance to alcohol especially 70% IPA. The rest of the industry shares this concern and frustration. GMPPENS are in fact cGMP compliant indelible ink as prescribed by the FDA. However, most alcohols (including 70% IPA) will smear "indelible ink" to some degree. It is highly recommended that companies approach the handling of the documents and use of the pens through training and awareness to reduce the exposure of 70% IPA to documents.

GMPPENS allow users in GMP environments to clearly identify and avoid using pencils, gel pens, erasable pens, etc. GMPPENS may be wiped down with 70% IPA for cleanroom and BSC use but the ink is subject to smearing with higher concentrations alcohol.

Please feel free to contact me with any questions or concerns regarding this issue. For additional information and ordering please visit http://www.gmppens.com/.




Best regards,

Justin Pawlik

Management's Commitment to VMPs

Welcome back to the Kymanox Midwest Operations Blog.

My last post outlined the commitments made in Validation Master Plans. Of the three listed, the commitment from the management from the organization is one of the most important. This shows that management is dedicated to the outline of how and why validation must occur; it is also a reflection of the organization's values and objectives.

The Commitment from Management
A VMP, must first and foremost, contain a commitment to compliance and validation from the management of the organization. The overall commitment from management describes the organization’s values, global objectives, and global approaches for maintaining the validation quality system. Documenting this information is consistent with ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which states: “The company’s overall policy, intentions, and approach to validation….should be documented.” (1)

Management’s commitment to achieving compliance is a regulatory expectation which can be accomplished through an effective validation program. ICH Q10, Pharmaceutical Quality System (2), 21 CFR § 820.20 (3), and the International Organization for Standardization (ISO) 9001 (4) quality assurance model all refer to the need for a commitment from management in order to achieve compliance. The specific topics included in the policy section of a VMP form the management’s overall commitment to validation.

First, the VMP must broadly define the organization’s values with respect to validation. Just as a child’s values are developed from parents, so too are the values of employees developed from management. Defining the organization’s values regarding validation creates an environment where validation is viewed as an essential quality system. Validation is not simply an activity that is complete when all required tests on the systems have been executed and passed.

Outlining the organization’s values in the VMP is important because it describes the validation philosophy by which the organization operates and monitors its commitment to compliance and validation. Since the VMP is typically requested by inspectors prior to or during an audit, including this information in the VMP demonstrates management’s commitment to validation.

The VMP must also include management’s global objectives for validation. These objectives outline the goals for the validation program. Goals that are written down have a much higher probability of being achieved than those that are not. Goals for validation are no different. Including the objectives for validation in the VMP is a commitment to achieving those goals from the management of the organization.

In addition to including global objectives for validation, the VMP must include global approaches for ensuring that the validation program is both effective and accurate. Every system must be monitored and controlled after implementation to make certain that it continues to operate as intended. A frequency schedule for evaluating validation status shall be applied to each area based on criticality and quality risk. Including a plan for maintaining the validation program re-affirms management’s commitment to validation.

Any comments, questions, and suggestions are welcomed.


Best regards,


Justin Pawlik


REFERENCES
1. ICH, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 04 June 2008.

2. ICH, Pharmaceutical Quality System Q10, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 09 November 2005.

3. Quality System Regulation. Code of Federal Regulations Title 21, Volume 8, Part 820 1 April 2007.

4. ISO 9001:2000 Quality Management Systems—Requirements, Section 4.1.

VMPs As Commitment Documents

One of the many services we provide at Kymanox is commissioning and validation of many different types of systems, from equipment to software. Kymanox not only executes commissioning and validation of systems, but we also create all of the documents to support validation. One of the documents that is usually created to support validation is the Validation Master Plan.

In the pharmaceutical, biotechnology, and medical device industries, it is paramount that the products manufactured are done so under strict guidance and supervision. Quality systems are put into place to ensure the safety and efficacy of the product; while validation ensures that systems, equipment and processes are reproducible and reliable. The Validation Master Plan (VMP) is the primary document that houses all aspects of the validation process and conveys managements overall intent, including defined validation scopes, scheduling of required work and responsible persons.

A VMP is more than a plan for executing validation. It is a commitment from the organization to ensure that the validated systems satisfy regulatory expectations. There various sections in a VMP contain different commitments from the organization. While the VMP is used to plan validation and outline the commitments from the organization, it is also a forward-looking document that must include a commitment for maintaining the validated state of systems in the future, as well as achieving a validated state for systems in the near-term.

COMMITMENTS IN A VMP

The VMP is viewed by regulatory agencies and auditors as a commitment document and is frequently one of the first documents requested in audits. A VMP is an overall commitment to ensure that systems, equipment and processes are validated and in compliance with governmental regulations. It demonstrates that the products manufactured from those systems and processes meet safety and efficacy requirements for the end customer. The subsequent posts to this blog will discuss the following specific commitments made in a VMP:

• A commitment from the management of the organization
• A commitment to how compliance is achieved
• A commitment to properly planning all aspects of validation
  

Any comments or questions are welcomed.

Best regards,

Justin Pawlik

Introduction Post

Welcome to my new blog about working as an Operations Executive in the Pharmaceutical, Bio, and Medical Device industries. Specifically I will be discussing articles written by my staff and me for various technical journals. The reasons for writing and publishing the articles are two-fold; Kymanox has an opportunity to educate the masses by writing about what we do on a daily basis; and we are able to promote Kymanox by having our company name published in well-respected technical journals.





I have been working at Kymanox for approximately two years. Coming from a very large pharmaceutical organization, I truly enjoy and cherish the dynamics of a smaller company. Kymanox is very nimble and can react to the changing times much faster than larger more bureaucratic companies. For this reason, Kymanox is not just surviving during these difficult economic times but actually thriving!

Kymanox (ki’-mah-noks’) is derived from Greek and means Ideal Knowledge Transfer™. The company was founded in 2004. Kymanox focuses on providing Ideal Knowledge Transfer (IKT) to help organizations achieve predictable project success. We provide comprehensive services on all of our projects to ensure the satisfactory completion of all scoped worked while remaining within all budgetary, schedule, and quality constraints. Since Kymanox is able to provide solutions to companies on a per-project-basis, we remain lean and efficient.

Kymanox is interested in creating long-term value for its clients. All work preformed is done on a project basis and each project starts with a value proposition analysis. It is this analysis that determines what value Kymanox can and will provide. In today’s business environment, it is sometimes difficult to identify all the customers and stakeholders for a given project or product. Keeping this in mind, Kymanox takes special care in handling multi-party projects. Scoped deliverables remain on-time and on-budget while keeping overall customer satisfaction high. Lastly, Kymanox emphasizes communication and transparency to its own operations so that decision makers and contributors are empowered with accurate and timely information.

In contrast to the traditional consulting model, Kymanox offers its clients a full-range of services related to Technical Project Management, Engineering, Process Operations, Quality & Regulatory Compliance, Commissioning & Validation, and Automation & Software with staffing that matches only what the project requires. Utilizing our experiences and talents, we have also developed various templates and training packages to assist other companies in providing Ideal Knowledge Transfer to their employees.

If you are looking for best-in-class services, please contact Kymanox.

Over the following weeks and months, I will update this blog with information that might be useful to those in this industry. Comments and suggestions are welcomed.

Best regards,

Justin Pawlik