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Continuous Manufacturing: Future is Here

June 6, 2016 by
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For Improved Quality in Pharmaceutical Manufacturing, a cleaner, flexible, and more efficient manufacturing practice is here and it is called continuous manufacturing.   Traditional manufacturing practice in Pharmaceutical is known as “batch” manufacturing, a process that manufacturing experts from the 1950s would easily recognize.   The unique benefits of continuous manufacturing is integrated processing with fewer steps, smaller equipment and facilities, and real-time continuous product quality monitoring.  Contributing to reduce costs, improved product supply reliability, and a smaller ecological foot print.

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Continuous Manufacturing is also consistent with FDA Guidelines on Process Validation using Quality by Design principals.  (see our blog on FDA Guidelines on Process Validation: Then and Now)

Regulators have been encouraging continuous manufacturing technology due to the imminent advantages to product and patients.  US FDA approval of Janssen Pharmaceutical Inc. continuous manufacturing production line in April 2016 is a milestone for Pharmaceutical industry. (See FDA Blog post on this milestone).  It is the first significant approval of a change of production method from batch based unit operation to a continuous manufacturing process.

The Guidance for Industry on Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, issued by US FDA in December 2015 provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technologies such as continuous manufacturing technology to FDA.

The regulators encouragement to utilize modern manufacturing technologies comes from the fact that pharmaceutical manufacturing has the potential to significantly impact patient care. Applying continuous manufacturing technology introduces long term manufacturing cost reduction and an enhanced supply reliability.  Given the recent impact of drug shortages on patients around the world, regulators are more than eager to support emerging technologies for continuous manufacturing.

One of the benefits of implementing continuous manufacturing is to introduce on-line quality monitoring and testing as opposed to end point quality testing as applied for batch manufacturing processes. In addition to the uninterrupted supply, Process Analytical Technologies (PAT) potentially increases the quality monitoring frequency.  To support such initiatives, Compliance Associates released in 2015, Validator®  for Process Validation, an integrated software solution purposely built for the needs of pharmaceutical industry.

Process-Validation-Flyer---2015.jpgValidator® has the capability to collect data sets and provide real time data trending. The system is an ideal solution for pharmaceutical Continued Process Verification (CPV) lifecycle stage for both batch processing and continuous manufacturing technology.  Validator® has the capability to detect adverse trends on an ongoing basis and notify the user as assigned.

In addition to administering the Continued Process Verification (CPV) program for the entire organization with cross site visibility, the Validator® system also delivers capabilities required for a Quality by Design (QbD) based Process Design stage and Process Performance Qualification stage as recommended by US FDA and EMA regulatory guidance. One example is the Risk Assessment tool built-in to Validator®. The integrated solution offered by Validator® also makes powerful data mining possible in line with the current regulatory philosophy of facilitating quick data driven decision making based on sound science.

For more information on Validator’s integrated approach for the support of continuous manufacturing and Quality by Design for Process Validation, email info@complianceassociates.ca. To see a sneak peak of Validator, click here for a 2 minute video demo.

 

 

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