The Enterey Blog

Enterey News September 2012

Posted by Tita Tavares on Thu, Sep 20, 2012 @ 03:18 PM

 

Community Corner

Enterey Community Corner

Helping Those In Need Get Dressed to Impress

At Enterey, our business is providing growing life sciences companies with operations solutions that allow them to focus on what they do best. As a company-wide initiative, we also like to focus on doing our best, not just with the services we offer but also for our community. Partnering with companies like Robert Half International—an organization that has helped over 5,000 people return to the workforce after poverty, abuse, or military duty—our contributions become even more impactful. 
Last month, Enterey participated in Robert Half’s suit drive benefiting Working Wardrobes of Orange County. The goal was to collect donations of professional attire and accessories to help empower people of all backgrounds to confidently enter the workforce and achieve self-sufficiency. With the help of our friends and family, we donated everything from well-kept designer suits to bags full of barely worn shoes, all of which will soon help people seeking employment get “dressed to impress.” 
Thanks to Office Team Laguna Niguel, a Robert Half Company, for allowing us to participate in this initiative and make a difference in our community.
 
 

What's in The News for Enterey?

Enterey Consulting Partners With DEI to Support the Creation and Protection of Shareholder Value for the Life Sciences

Enterey DEI Risk Management 5
IRVINE, CA--(Marketwire - Sept 05, 2012) - Enterey Life Sciences Consulting, a leading provider of consulting services focused on manufacturing and quality operations for life sciences companies, introduces Decision Empowerment Institute (DEI) PRO-Enterprise Management Risk Quantification Approach for assessing operational and compliance risk, resulting in a sustainable risk-mitigation strategy and protecting potentially billions in shareholder value. 

 

 

 

Risk Management Seminar with DEI - October 4, 2012 at 11:30 am

Can you, as a stakeholder in your organization, answer the following "Five Questions" related to your company's problems, risks, and opportunities (PRO)? Find out why you should be concerned and learn how to prioritize your risks. Registration information will be announced soon. 

 
 

8th Annual Quality & OPEX in Pharma & Biotech - Frankfurt, Germany | October 4-5, 2012

Enterey CEO, Mike Ferletic, will present a Case Study on The Importance of Proactive Compliance and Preparing for GMP Inspections.

Register for the conference >>

 
 

Project Update: Consultant Assists in Successful PAI to Support Commercial Launch

A small drug-development company in Southern California set out with the goal of acquiring a commercial license for its oligonucleotide manufacturing facility in 2012. See how the Enterey consultant was able to assist in a successful European PAI to support the client's commercial launch.

View details >>

 

 

 

Project Update: Tech Transfer Leads to Spend Analysis & Increased Utilization

A prominent biotech/pharmaceutical manufacturer requested assistance in transferring its clinical manufacturing capabilities to a newly commercialized facility. Read more about how Enterey's consultant led the client to refrain from a site closure.

View details >>

 

Tags: Enterey News, Life Sciences Industry News, Life Sciences News & Hot Topics, Quality Risk Managment, Risk Management, Life Sciences, Proactive Compliance

Key Points & Concepts: FDA’s New Guidance Docs for Process Validation

Posted by Tita Tavares on Mon, Apr 11, 2011 @ 11:00 AM

FDA: NEW Guidance for Industry Process Validation: General Principles and Practices - Issued January 2011

FDA’s new guidance aligns process validation with the product lifecycle concept and ICH Guidelines Q8 (R2) Pharmaceutical Development, Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System).

The guidance encourages the implementation of modern development concepts of Quality by Design (QbD), such as design space, Quality Risk Management (QRM) and control strategy, throughout the product lifecycle.

The lifecycle concept links product and process development, qualification of commercial manufacturing process, and maintenance of the process in the state of control during commercial production.

Process Validation Key Points and Concepts

The guidance supports process improvement and innovation through sound science and knowledge management.

Effective process validation contributes significantly to assurance of drug quality and that the drug produced is fit for its intended use.

The guidance defines process validation as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

 

Process validation activities occur over the product and process lifecycle in 3 stages:

1 | Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. The goal of this stage is to design a process suitable for routine commercial manufacturing that can consistently deliver a product that meets its quality attributes.

Process knowledge and understanding are obtained and captured during this stage. Studies should be conducted with sound scientific methods and principles and documented. Design of Experiment (DOE) studies help develop process knowledge. Risk analysis can be used to screen variables to minimize number of experiments while maximizing knowledge gained. Process information from product development can be leveraged in the process design stage and used in process qualification and continued process verification stages when the process design is revised or the control strategy changed.

The process knowledge and understanding gained at this stage form the basis for establishing a process control strategy.

 

2 | Process Qualification: During the process qualification (PQ) stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

PQ consists of 2 elements:
1) Facility design and qualification of equipment and utilities
2) Process performance qualification (PPQ).

Facility design and commissioning precede PPQ. CGMP procedures must be followed.

Completion of this stage is necessary prior to commercial distribution. If acceptable, products can be released for distribution.

The PPQ combines the actual facility, utilities, qualified equipment, and trained personnel with the commercial process under normal operating conditions.

A successful PPQ confirms process design and demonstrates commercial manufacturing process performs as expected. PPQ is based on sound science and manufacturer’s overall level of product and process understanding and demonstrable control. Higher level of sampling, additional testing, and greater scrutiny of process performance usually occurs during PPQ. The PPQ protocol is reviewed and approved by quality unit. The PPQ protocol execution and report, also reviewed and approved by all appropriate departments and quality unit, state a clear conclusion that the process is in a state of control.

 

3 | Continued Process Verification: During this stage, there is continual assurance that the process remains in a state of control (validated state) during commercial manufacture.

An on-going program to collect and analyze product and process data must be established. Data collected includes process trends and quality of incoming materials or components, in process materials, and finished products. Data should be statistically trended by trained personnel Production data is collected to evaluate process capability and stability. Continued process monitoring and sampling occurs at the level established during process qualification until sufficient data are available to generate significant variability estimates. Monitoring can then be adjusted to statistically appropriate and representative levels.

Knowledge and understanding gained is the basis for establishing an approach to control the process.

Manufactures should understand the sources of variation, be able to detect the variation, understand the impact of variation on the process and product, and control the variation commensurate with the level of risk to the process and product.

Controls can consist of material analysis and equipment monitoring at significant processing points.

Manufacturers of legacy products can benefit from knowledge gained from the original process development, qualification and experience. Legacy products and processes would likely begin with Stage 3 activities for continued process verification.

Homogeneity within a batch and consistency between batches are goals of process validation activities. 

 

Recommendations:

FDA recommends an integrated team approach to process validation with subject matter experts from process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance. Project plans and full support of senior management are necessary for success.

Published by: Jim Anthony, Enterey | Director

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Up Next: What is different about the new process validation guidance? What should we be doing differently?

 

Tags: Life Sciences Industry News, Life Sciences News & Hot Topics, FDA New Guidance for Industry, Process Validation, ICH Q8, ICH Q9, ICH Q10, QRM, Quality Risk Managment, Process Verification, Process Qualification, Facility Design, CGMP, DOE, Quality Assurance, Drug Manufacturers