Continuous Process Verification (What it takes for a rapid set up?)

ICH Q10 Guidance and Process Validation Guidance published by FDA in 2011 both emphasizes routine process monitoring and continued process verification (CPV) as an integral part and a third and final stage of process validation and its life-cycle management.

A nice and very detailed case study has been published by BPOG (Biophorum Operations Group) on how to implement CPV. Though this case study is very detailed, here below is summarized in a flow chart the steps involved in setting up CPV. This gives an idea of what procedures, tools and efforts needed to rapidly setup a CPV program at your organization.

For definitions of CPP, KPP and MP refer to our July 27, 2015 blog on SPC.

Steps 1 through 4 involves scientific judgement hence cannot be automated.  This will involve some initial lag time to establish a CPV program. However an efficient knowledge management platform can greatly help in rapidly identifying parameters to monitor and establishing trending techniques and can significantly help in reducing time of deployment.

Steps 5 through 11 require fair amount of labor and can become a daunting task to routinely monitor hundreds of parameters (especially for complex biologic products), investigate trends and keep updating/adjusting the control limits to keep a check on process variability and capability. Adding to this if your site/organization is a multi product commercial manufacturing site this activity become impossible to perform manually and keep up the frequent reviews of processes with limited resources (FTE's) available. Most of the steps from Steps 5 through 11 can easily be automated and a specially designed software tool for CPV purpose can prove to be great advantage having capabilities in terms of:

• data integration and warehousing of all relevant historical process information
• lot traceability and genealogy
• performing correlations across process steps for quick troubleshooting
• overlaying batch trends
• templating specific process parameters for routine periodic trending
• historical limits management
• validated reporting

Few tools in this space have emerged recently (in last few years) catering to process data management and particularly CPV. 

Our ProcessPad platform is industry first completely web-based bioprocess data management software for rapidly deploying CPV in your organization. Contact us for more information at info@simplyfeye.com.

More about us at: http://www.simplyfeye.com

Simplyfeye at ISPE Boston Product Show (October 7, 2015)

 Easy | Intuitive | Collaborative | Part11 Compliant 

Visit our booth at the upcoming ISPE Boston Product Show and know more about our product ProcessPad.

Event Details:
Booth # 2214
ISPE Product Show XXIV
Wednesday October 7, 2015
Gillette Stadium Clubhouse
Foxborough, MA

More Details about the event at: http://productshow.ispeboston.org/

Statistical Process Control (SPC) and Continuous Process Verification (CPV)

Simplyfeye team is recently involved in a major project with a multinational pharma company where we are helping the company setup a process monitoring program of all its commercial manufacturing processes using our product ProcessPad.

We all know SPC is an important ingredient of CPV and a process control chart (as shown below) forms the central piece of the puzzle for SPC and any process monitoring program.

Figure 1: Process Control Chart

Here is how we help setup a Process Monitoring program.

Step 1: What to SPC?

Figure 2: Selecting parameters for routine monitoring

Step 2: What limits to apply?

Figure 3: Controlling the process within limits

Step 3: How to estimate control limits?

Figure 4: Statistical rules to estimate control limits

Step 4: How to identify a trend?

Step 5: How it all ends up in ProcessPad?

Figure 5: Outcome of Steps 1 through 4 in real life

Step 5 above shows how ProcessPad platform provides a tool set for rapidly deploying a process monitoring program for your continuous process verification efforts that can be easily validated in GMP environments with minimal efforts.

For more information contact us at: info@simplyfeye.com

© Simplyfeye       |        info@simplyfeye.com         |         http://www.simplyfeye.com

Simplyfeye presenting at Windshire Seminar in Cambridge, MA

Getting the Most Out of Your Process Data: 

Techniques for Data Acquisition and Analysis and  

Why It is Important

The Windshire Group, LLC and Ops2Data, LLC proudly invite you to a symposium featuring presentations from two prominent industry experts (see profiles below) speaking on Process Data Analytics and Ongoing Process Verification, followed by a roundtable discussion.

Attendees also will benefit from networking with their peers.

A complimentary Continental breakfast and will be included with your free registration.

When:       Thursday, June 25, 2015

Where:      The Seminar Room

Athenaeum Center

215 First Street

Cambridge, MA 02142

8:00 a.m.                       Continental Breakfast / Networking

8:30-11:00 a.m.           Seminar and Roundtable Discussion

How:         RSVP  by info@windshire.org or 1-844-686-5750, ext. 102

                   with number of people attending

Presentations by: 

James Blackwell, Ph.D., M.B.A.

President, The Windshire Group, LLC

Biopharmaceutical, Medical Device, & Cell Therapy

Comprehensive CMC Consulting^tm Services

A prominent industry consultant with broad technical and quality experience encompassing early process development to commercial operations for pharmaceutical and biopharmaceutical including monoclonal antibodies, parenterals, vaccines, recombinant proteins, oral dosage forms, peptides, antibiotics, medical devices, and cell therapy products. Dr. Blackwell is a member of ISPE, RAPS, PDA, and AAPS and has graduate training in chemical engineering, microbiology, and business and technology management.

For more information about The Windshire Group please go to our website at

http://www.windshire.org

Anshuman Bansal

Founder, Simplyfeye 

Mr. Bansal is a leading expert on process analytics. Simplyfeye provides manufacturing intelligence solutions for bioprocess scientists and engineers and empower them with contextual information for making better, faster data driven decisions.

For more information about Simplyfeye please visit their website at http://www.simplyfeye.com/

© Simplyfeye       |        info@simplyfeye.com         |         http://www.simplyfeye.com

Non-conformance Triages: Analytical Results Assay Background Data

In the biopharmaceutical production world we are always surrounded by all kinds of quality impacting non-conformances. Typically a site triage team investigate these non-conformances that involves folks from Production, QA and QC (and sometimes people from Process Development or Manufacturing Sciences) to meet periodically to track, resolve, assign root cause and identify corrective and preventative actions. This cross-functional team needs information from variety of cross-functional data sources quickly to resolve issues. Typical information sources that are scraped during an investigation are shown in image below as the basic building blocks of an investigation process. Instant access to the data from these building blocks (in the context of the non-conformance) is very essential so that the group can resolve these on the fly while having discussion during the meeting itself.

Most often in investigations assay background data like system suitability, calibration curve details (that help in assessment of assay fitness) are difficult to access and may get overlooked from the information platter due to hastiness in getting to an assignable cause and CAPA. If the assay background data is available instantly the team can readily answer questions related to

• sources of variability in assay results

• re-evaluate assay suitability criteria and variability in system suitability itself

• variability in calibration curves and assessment of its limits criteria

• variability in internal reference standards

• and much more….

ProcessPad(TM) now has the capability of bringing the test results’ background assay data along with other investigation building blocks on the same single access window. This will help triage team get instant access to all relevant data and readily get answers to their investigation related queries right there during the triage meeting. A typical trend outcome (via ProcessPad) for an assay system suitability is shown below

About ProcessPad(TM)

ProcessPad(TM) is bio+pharma process management software to manage process data in development and commercial manufacturing of biopharmaceuticals.

© Simplyfeye Softwares Pvt Ltd, Hyderabad, India      |      info@simplyfeye.com       |      http://www.simplyfeye.com

Simplyfeye among best product poster presented at IKMC 2013

Simplyfeye team recently attended a poster conference (http://www.ikmc2013.com/ikmc/index.html) organized by IKP Knowledge Park at Hyderabad,India. This conference is an annual event organized by IKP to showcase innovative product development in the country and is attended by industry veterans , government representatives and angel investors / venture capitalists. More than 100 innovators and start-up companies presented their ideas in the form of posters. Our poster titled "Bioprocess Monitoring" based on our innovative product ProcessPad was very well appreciated. We are excited to inform that we were adjudged second best poster in the conference. This recognition boost our confidence and gives Simplyfeye team encouragement to continue our journey of building quality products and solutions for the bio/pharmaceutical drug manufacturing industry. We thank IKP team for inviting us and giving us chance to present our ideas. Sharing below is the poster that we presented.

Additional note on Bioreactor Contamination Control: Some Simple Strategies to Consider

Further to my earlier post on using process data for troubleshooting and control of bioreactor contaminations, I recently came across a wonderful article in Pharmaceutical Engineering for simple strategies to keep a check on contamination events published by Ryan Schad and his team (from Eli Lilly & Co.) back in June 2010 issue of the magazine.

I especially liked the following checklist provided in this article.

The article elegantly describes the following considerations in good detail:

• handling of steam and condensate
• air removal
• cold spots
• equipment drains
• piping slopes
• elastomers
• methods of data collection from reactor for monitoring
• offline monitoring: sterile sampling techniques
• online monitoring: reactor probes and its sterility
• valves and dead lags
• agitator shaft seals

In addition to these I also recommend considering these:

• Incorporating a Helium Leak Test: Since helium can penetrate very small cracks and crevices, filling the bioreactor with helium prior to a batch and snooping for leaks is very quick and easy way to identify potential leaks especially in deteriorated elastomers. Most of the leak testing methods that are usually employed are bubble test or pressure decay. Helium can be a good alternative if you find any of the current methods that you employ are not effective.  
• Using inexpensive Tempilstik temperature crayons: If your plant is old or there is no way to install additional temperature sensors on your valves to check for effectiveness of your SIPs, you may consider good old temperature sticks to confirm the effectiveness of sterilizations each time and record the checks in your SIP batch records. (Note: This process is laborious but can be an easy cost effective solution for contamination check and also historizing SIP data for future troubleshooting)

If you think you already have incorporated these checks and still are having problem in controlling your contamination events its high time you take help of external consultants as they will help provide a third eye to the investigation. Most of the time taking the help of consultants who have already solved similar problems in various contexts earlier can help you overcome your own organizations' blind spots, internal politics or lack of expertise (internal transfers, attrition etc.).

Simplyfeye team can be one such resource to you that you can rely and can utilize our years of experience in solving such problems. Our team will help you implement effective CAPAs (and data systems) for future checks on such events.