Archive for category: General

Laughter, humor and smiling in the workplace can have a tremendously positive affect on a company’s culture. The use of humor, and the ability to produce and make humor, is associated with intelligence and creativity – two things highly valued in the workplace.

Smiling and laughter are free! They boost health, mood, longevity and success. When you smile, endorphins are released. We feel happier and less stressed, are able to think more clearly and creatively because our attention is widened, opening us to multi-tasking and insights that come from the fringes of our perception and subconscious.

Laughing is good exercise. It expands the lungs, stretching body muscles and stimulating homeostasis (maintenance of equilibrium). The added oxygen released by laughing replenishes and invigorates cells improving blood vessel function and increasing blood flow. A good bout of laughter can burn as many calories as rowing intensely for 10 minutes! Smiling – the universal sign of happiness – makes you appear more approachable, attractive, self-confident, self-assured and allows for easier interaction with others. When you smile you exude confidence and the ability to cope during stressful situations. Smiles use from 5 to 53 facial muscles, naturally lifting your face. Studies have shown smiling makes people appear younger. Smiling instantly improves spirits and reduces blood pressure. Infectious laughter and humor binds people together by promoting better teamwork, higher productivity (“whistle while we work”) and increased job satisfaction. Laughter is one of the most effective tools for keeping relationships fresh and exciting. When you’re in good spirits, learning ability is optimal because your mind opens to new ideas. When a learner breaks out of learning malaise, something unexpected is provided increasing the uptake of information; a neurological benefit occurs when emotion is experienced at the same time learning.

Written By: Nita Wilding, Assistant Controller

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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!

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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.

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.

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Teams of Integrated Commissioning & Qualification Corporation (ICQ) Consultants have played a central role in the development, implementation and execution of various quality by design systems as well as the commissioning and qualification of multiple manufacturing plants in the New England area and elsewhere, including some of the world’s largest biotechnology facilities. Now due to increasing demand for ICQ services and recent growth ICQ Consultants is expanding the services within the computer system validation (CSV) industry demand:

Overview: Title 21 CFR Part 11 requires; “Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.” With that said, Validation is confirmation by examination and provision of objective (documented) evidence that computer systems conform to user needs and intended uses, requirements are consistently fulfilled, and applicable regulatory requirements (such as 21 CFR Part 203, 21 CFR Part 820, etc.).

Validation, at its most basic level, is the process of ensuring that applications, systems, and/or environments satisfy intended functionality in a consistent and reliable manner. Primarily, validation is accomplished via software testing – the process of executing a predefined sequence of steps, emulating typical user scenarios and data, to determine if the application, system, and/or environment under evaluation performs as intended. Validation includes verifying:

• Requirements of the system are met (both regulatory and business)
• System performance (speed and accessibility) is acceptable
• Data integrity is properly maintained (not lost, improperly modified, etc.)

The primary benefit of validation is a level of assurance that the system will perform as required and intended during operation. A validated system should be more cost effective to maintain, yield greater Return on Investment (ROI), and result in reduced risk of data loss and issues with regulatory requirements.

ICQ Consultants provides a broad range of Computer System Validation (CSV) services in support of clients’ manufacturing, laboratory, and enterprise systems. We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical risk-based approach to computer system validation. And, by verifying the controlled development and implementation of computer systems, we ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and protect patient safety.

The following are a few key components of services provided:

• Validation methodology based on GAMP5 guidelines and risk-management practices
• Validation plan
• System risk assessment report
• User requirements specification
• System configuration specification
• Test plan
• Installation Qualification (IQ)
• Operation Qualification (OQ)
• Performance Qualification (PQ)
• Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11)
• Validation traceability matrix
• Quality assurance review

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Written By: Alfonso Guarracino, Senior Director of Information Technology

ICQ Consultants Corp.