Season’s Greetings!

Untitled

Everyone here at ICQ Consultants would like to wish our employees and colleagues a very happy holiday season and new year.  Thank you, everyone, for your hard work and dedication.  We appreciate all you do to assist in the success of our company.  We have had the pleasure to work with a multitude of outstanding professionals including both our employees and our clients.  Here is looking forward to a successful 2015!

ICQ

Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in-depth view of what we are all about: https://icqconsultants.com.

 

ICQ Consultants, Engineering Better Solutions

 

ICQ

Integrated Commissioning & Qualification Corporation (ICQ) is a leading provider of commissioning, qualification and verification services to companies in the life sciences and pharmaceutical industries. We develop programs and procedures that promote, facilitate and ensure compliance with stringent regulatory standards and our clients’ own internal quality standards. During our history, teams of ICQ consultants have played a central role in the commissioning and qualification of multiple manufacturing plants in the New England area as well as North Carolina. ICQ consists of eighty plus employees all qualified in the different areas of the industry that we as a company specialize in.

We thrive on the long-term success of our clients. We at ICQ make every effort to establish strong continuing relationships. Our company strives to blend in at the client site and become an extension of each client company we work with. ICQ offers many services from the start-up and commissioning of new facilities, utilities, process equipment and processes to decommissioning or project planning. No matter which service you require we have an experienced professional to place into our client sites.

◊ Equipment/Facilities CQ &V ◊ Process Engineering ◊ Process Validation ◊ Manufacturing Operations ◊ Quality Systems and Remediation ◊ Consent Decree Remediation ◊ Construction and Program Management ◊ Project Planning and Scheduling ◊ Compliance Support ◊ Quality Control and Assurance ◊ Re-Qualification ◊ Decommissioning ◊ Commissioning Activities (IV, OV, IQ & OQ) ◊ Engineering Change Management ◊ Cycle Development (CIP & SIP) ◊ Engineering Test Plans ◊ Start-Up and Turn-Over ◊ Shake Down Activities ◊ Project Execution ◊ Cleaning Validation (CIP/COP) ◊ Sterilization Validation (SIP/SOP) ◊ Process Validation ◊ Mixing Validation ◊ Clean/Dirty Hold Validation ◊ Expiry Validation ◊ Cleaning Verification (CV) ◊ Validation Maintenance ◊ Assistance with Compliance Audits ◊ Development and Management of Compliance Action Plans ◊ Regulatory Readiness Inspections and Training ◊ Response to Regulatory Citations and Warning Letters ◊ Design of Quality Systems for New Facilities or New Process Lines ◊ Ongoing QA/QC Support ◊ Preparation of Regulatory Filing and Review Documents ◊ Implementation of Quality by Design (QbD), ICH-Q9, ICH-Q10, ASTM E2476, ASTM E2500 Principles and Approach ◊ Project Managers ◊ Project Leads ◊ C&Q Technical Leads ◊ C&Q Consultants ◊ C&Q Engineers ◊ C&Q Specialists ◊ Documentation Specialists ◊ Construction Managers

ICQ_team1

Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in-depth view of what we are all about: https://icqconsultants.com.

 

The Process Validation Life-Cycle

PVgraphic1

Guidance on Process validation began in 1987 to address consumer recalls and complaints and assure consumers that their products were consistently made with the utmost quality. This guidance underwent some significant fundamental changes in 2011. If processes were “validated” as prescribed by the FDA guidance then why were products being recalled? Why were customers complaining about their products? Why was this happening? When something happens we ask why and get to the root cause(s).

The traditional approach for process validation was a snapshot in time. At a point in time a process demonstrated that it could achieve and maintain a state of control and consistently manufacture a particular product within prescribed acceptance criteria and quality standards. Controls were established to monitor the process and critical operating and performance parameters were identified and reproduced for a prescribed number of batches.

The FDA wanted to see more emphasis on process monitoring and demonstrating statistical control after you “validated” a process. An enhanced approach – a life-cycle approach was implemented and traditional process validation was divided into three stages/phases. Traditional process validation would correspond to Stage 2 activities. The transition from Stage 2 to Stage 3 is analogous to technology transfer to commercial routine manufacture. Stage 3 is the continuous process verification/validation of the commercial process.

process validation

Stage 1 Process Design, ensuring the work is down upfront to characterize and consistently reproduce within certain operating and performance parameters.

Stage 2: Process Qualification, qualifying equipment and utilities, performing process performance qualification (traditional process validation) ensuring the process is able to meet predetermined operating and performance parameters.

Stage 3: Continued Process Verification, ongoing monitoring of the process to ensure it continues to operate within established operating and performance parameters.

Validation is no longer a snapshot in time, it is composed of three stages, and each builds upon the other yet remains fluid. There is constant interplay between stages. Systems and process should be periodically evaluated to verify that they are still operating in a valid state. As experience is gained in commercial routine manufacturing, opportunities for improvements should be sought based on periodic review and evaluation, operational and performance data, and root-cause analysis of failures.

To maintain and control the manufacturing process, the focus had to become on process knowledge and process understanding throughout the life-cycle of the product. Understand and measure inherent product/process variability. A control strategy has to be developed to explain and justify how the product quality is managed and ensuring the operating and performance parameters remains in statistical control. Process control generates product consistency and quality. Process monitoring will provide the information needed to further understand the product/process and give you the information to refine your control strategy. In a feedback process, the continuous process verification is a key component assuring the ongoing effectiveness of the control strategy.

Some of my sources.

For the full article on Why did FDA change their Guideline on Process Validation? Click on http://www.gmp-compliance.org/eca_news_2600.html

Pharmaceutical Engineering Jan/Feb 2012   Control Strategy as the keystone of the product life-cycle, from product/process understanding to continuous process verification and improvement.

PV guidance, check the CDER guidance page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, the CBER guidance page at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or the CVM guidance page at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm

Written By: Lisa Conti, Senior Consultant

ICQ Consultants, Corp.

ICQ

Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in-depth view of what we are all about: https://icqconsultants.com.