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GAMP-5 Guidance for Computer System Validation

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GAMP-5 guidance, the related “V model” and the different software categories used to simplify the validation activities are nowadays considered the internationally recognised best approach for computer system validation. GAMP stays for “Good Automated Manufacturing Practice” and it is a guideline which is published by the ISPE, International Society for Pharmaceutical Engineering. The guideline is currently in Version 5.

Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5.

GAMP-5 is very important especially when the software application is provided by a supplier external to the organization. In fact this regulation requires users and suppliers to work together, each of them according to specific responsibilities, two gain the full validation of the software system.

Specifically, for the users, GAMP-5 provides a framework for validation activities to ensure that the system is fully validated according to its intended user before it moves to production. Suppliers, at the same time, can use GAMP to test the SW application for avoidable defects in the supplied system to ensure quality products are produced.

The Principles of GAMP-5 Guidelines

The GAMP-5 guideline for computer system validation is based on five principles:

  • Product and Process Understanding
  • Lifecycle approach within QMS
  •  Scalable Lifecycle Activities
  • Science Based Quality Risk Management
  • Leveraging Supplier Involvement

Product and Process Understanding

It is essential to fully understand the software product and the related process in order to complete a validation activity. the validation effort shall be concluded with a “Fit for Use” statements and this cannot be performed if the most critical product functionalities are completely understood and tested. The critical functionalities are the ones that have an impact on the safety of the patient, on quality of the product and on security and integrity of the data.

Lifecycle approach within QMS

The lifecycle management of the computer systems under validation need to be managed within the quality management system of the organization. This practically means, as per GAMP-5 methodology, to have a detailed SOP highlighting how each state of the lifecycle of the software application is managed.

Having all the phases of the software lifecycle integrated within the quality system means providing evidence that the requirements are indeed defined within the concept phase or having detailed SOP for release, maintenance and retirement of the software.

Scalable Lifecycle Activities

The lifecycle activities of the software application under validation can be scaled or modelled according to different parameters:

  • System impact on patient safety, product quality, and data integrity (Risk Assessment)
  • System complexity and novelty
  • Outcome of supplier assessment

The V model which, according to GAMP-5, is taken as reference for the lifecycle model of the software application under validation. This is where different GAMP-5 categories can be used to classify the software applications; the strength of the validation efforts are dependent from each category. You can refer to the procedure P-06 : Computer System Validation for a description of the different categories.

The V model can be altered or modified according to the parameters mentioned above. GAMP 5 make it clear the type of validation requirements associated with a system should be tied to how new and complex they are; thus it is tied to the different GAMP-5 categories.

Science Based Quality Risk Management

The GAMP-5 approach suggests to concentrate validation efforts on the most critical functions of the software application, which should be identified using a risk management approach. This is where a clear comprehension of the product and the process is crucial to determine the potential risks to patient safety, product quality and data integrity.

In order to apply risk management approach, the organization shall proceed in a stepwise manner, based on the following sequence:

  • Identify functions which impact patient safety, product quality and data integrity
  • Perform functional risk assessments
  • Implement and verify appropriate controls
  • Review risks and monitor the implemented controls

For the methodology of how functional risk assessment shall be implemented, refer to the computer system validation procedure:

Leverage the involvement of the supplier

According to GAMP-5, the organization is definitely responsible for performing validation of the software application they are using. However, regulated companies can leverage their supplier’s own documentation, including existing test documentation to avoid wasteful effort and duplication. Collaboration between suppliers and the organization responsible for validation is of fundamental importance to ensure the validation efforts are meaningful.

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Source: https://www.qualitymeddev.com/2021/01/17/gamp-5/

Medical Devices

How Rani Therapeutics’ robotic pill could change subcutaneous injection treament

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A new auto-injecting pill might soon become a replacement for subcutaneous injection treatments.

The idea for this so-called robotic pill came out of a research project around eight years ago from InCube Labs—a life sciences lab operated by Rani Therapeutics Chairman and CEO Mir Imran, who has degrees in electrical and biomedical engineering from Rutgers University. A prominent figure in life sciences innovation, Imran has founded over 20 medical device companies and helped develop the world’s first implantable cardiac defibrillator.

In working on the technology behind San Jose-based Rani Therapeutics, Imran and his team wanted to find a way to relieve some of the painful side effects of subcutaneous (or under-the-skin) injections, while also improving the treatment’s efficacy. “The technology itself started with a very simple thesis,” said Imran in an interview. “We thought, why can’t we create a pill that contains a biologic drug that you swallow, and once it gets to the intestine, it transforms itself and delivers a pain-free injection?”

Rani Therapeutics’ approach is based on inherent properties of the gastrointestinal tract. An injecting mechanism in their pill is surrounded by a pH-sensitive coating that dissolves as the capsule moves from a patient’s stomach to the small intestine. This helps ensure that the pill starts injecting the medicine in the right place at the right time. Once there, the reactants mix and produce carbon dioxide, which in turn inflates a small balloon that helps create a pressure difference to help inject the drug-loaded needles into the intestinal wall. “So it’s a really well-timed cascade of events that results in the delivery of this needle,” said Imran.

Despite its somewhat mechanical procedure, the pill itself contains no metal or springs, reducing the chance of an inflammatory response in the body. The needles and other components are instead made of injectable-grade polymers, that Imran said has been used in other medical devices as well. Delivering the injections to the upper part of the small intestine also carries little risk of infection, as the prevalence of stomach acid and bile from the liver prevent bacteria from readily growing there.

One of Imran’s priorities for the pill was to eliminate the painful side effects of subcutaneous injections. “It wouldn’t make sense to replace them with another painful injection,” he said. “But biology was on our side, because your intestines don’t have the kind of pain sensors your skin does.” What’s more, administering the injection into the highly vascularized wall of the small intestine actually allows the treatment to work more efficiently than when applied through subcutaneous injection, which typically deposits the treatment into fatty tissue.

Imran and his team have plans to use the pill for a variety of indications, including the growth hormone disorder acromegaly, diabetes, and osteoporosis. In January 2020, their acromegaly treatment, Octreotide, demonstrated both safety and sustained bioavailability in primary clinical trials. They hope to pursue future clinical trials for other indications, but chose to prioritize acromegaly initially because of its well-established treatment drug but “very painful injection,” Imran said.

At the end of last year, Rani Therapeutics raised $69 million in new funding to help further develop and test their platform. “This will finance us for the next several years,” said Imran. “Our approach to the business is to make the technology very robust and manufacturable.”

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Source: https://techcrunch.com/2021/03/05/how-rani-therapeutics-robotic-pill-could-change-subcutaneous-injection-treament/

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Medical Devices

How Rani Therapeutics’ robotic pill could change subcutaneous injection treament

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A new auto-injecting pill might soon become a replacement for subcutaneous injection treatments.

The idea for this so-called robotic pill came out of a research project around eight years ago from InCube Labs—a life sciences lab operated by Rani Therapeutics Chairman and CEO Mir Imran, who has degrees in electrical and biomedical engineering from Rutgers University. A prominent figure in life sciences innovation, Imran has founded over 20 medical device companies and helped develop the world’s first implantable cardiac defibrillator.

In working on the technology behind San Jose-based Rani Therapeutics, Imran and his team wanted to find a way to relieve some of the painful side effects of subcutaneous (or under-the-skin) injections, while also improving the treatment’s efficacy. “The technology itself started with a very simple thesis,” said Imran in an interview. “We thought, why can’t we create a pill that contains a biologic drug that you swallow, and once it gets to the intestine, it transforms itself and delivers a pain-free injection?”

Rani Therapeutics’ approach is based on inherent properties of the gastrointestinal tract. An injecting mechanism in their pill is surrounded by a pH-sensitive coating that dissolves as the capsule moves from a patient’s stomach to the small intestine. This helps ensure that the pill starts injecting the medicine in the right place at the right time. Once there, the reactants mix and produce carbon dioxide, which in turn inflates a small balloon that helps create a pressure difference to help inject the drug-loaded needles into the intestinal wall. “So it’s a really well-timed cascade of events that results in the delivery of this needle,” said Imran.

Despite its somewhat mechanical procedure, the pill itself contains no metal or springs, reducing the chance of an inflammatory response in the body. The needles and other components are instead made of injectable-grade polymers, that Imran said has been used in other medical devices as well. Delivering the injections to the upper part of the small intestine also carries little risk of infection, as the prevalence of stomach acid and bile from the liver prevent bacteria from readily growing there.

One of Imran’s priorities for the pill was to eliminate the painful side effects of subcutaneous injections. “It wouldn’t make sense to replace them with another painful injection,” he said. “But biology was on our side, because your intestines don’t have the kind of pain sensors your skin does.” What’s more, administering the injection into the highly vascularized wall of the small intestine actually allows the treatment to work more efficiently than when applied through subcutaneous injection, which typically deposits the treatment into fatty tissue.

Imran and his team have plans to use the pill for a variety of indications, including the growth hormone disorder acromegaly, diabetes, and osteoporosis. In January 2020, their acromegaly treatment, Octreotide, demonstrated both safety and sustained bioavailability in primary clinical trials. They hope to pursue future clinical trials for other indications, but chose to prioritize acromegaly initially because of its well-established treatment drug but “very painful injection,” Imran said.

At the end of last year, Rani Therapeutics raised $69 million in new funding to help further develop and test their platform. “This will finance us for the next several years,” said Imran. “Our approach to the business is to make the technology very robust and manufacturable.”

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Source: https://techcrunch.com/2021/03/05/how-rani-therapeutics-robotic-pill-could-change-subcutaneous-injection-treament/

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Ecommerce

UAT Group Inc, Acquires 20% of Next Casting Technologies

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Tampa FL, March 4th,2021 – OTC PR WIRE – Umbra Applied Technologies Group, Inc (OTC Pink: UATG) announced today that it has purchased 20% of the Austin, Texas based medical company Next Casting Technologies. The global orthopedic casting, splinting, braces and support market was valued at US $4.6 billion in 2015 and is expected to reach US $7.9 billion by 2024, at a CAGR of 6.4%. Next Casting Technologies has projected its first-year revenues to be $16.1M once it launches with a five-year evaluation in excess of $80M. UAT Group will deliver the $5M purchase price amortized over the next 24 months.

Chief Executive Officer, Alex Umbra commented, “Next Cast represents the tip of the spear in casting technology. What they have created is impressive and singular in the market. We initially partnered with NextCast on producing one of the components in their next generation cast which utilizes our industry leading antimicrobial technology Hygieia. After 2 years of collaborating on this unique project, it seemed only natural to have Next Cast become part of our family in a more definitive way. This addition to our suite of companies supports our commitment to building value within our subsidiary and strategic network”.

Next Casting Technologies (NCT) founded in 2016, is a research and design-centric, biomedical technology company, with an expanding portfolio of intellectual property. The NCT team of experienced engineers, designers, certification experts and business professionals combine advanced design with paradigm shifting technology engineered to disrupt and transform the casting, bracing and splinting space.

The current SmartCast technology is ready for commercial production and introduction into the market, with advances in second generation models currently under development. The next generation SmartCast will feature an integrated microprocessor not just for simplifying and managing the cast curing time, but will also include the ability to detect swelling, and promote the fracture healing process with active bone growth stimulation. Their patent pending technology provides multiple pathways for product line expansion within the lucrative specialty casting and custom bracing markets.

The CEO and inventor of the NCT product line stated,” We are currently in the final stages of initial commercial production and building domestic sales.  As revenue increases, design and production work will continue to expand product offerings to include bracing, splinting and specialty casting, utilizing NCT’s unique technology.  Over the next 36 months, the NCT Board vision is to guide the company into an international brand. We are currently engaged with a national medical products and service provider to provide our product lines to their clients. I know I speak with everyone at Next Cast when I say we could not be more excited about our future with our new strategic partner UAT Group”.

For more information about Next Cast go here: https://www.nextorthocast.com/

About Umbra Applied Technologies Group, Inc.:

The firm is located in Tampa Florida and focuses on advanced technologies across many disciplines. UAT Group is a holding company with interests in both public and private companies during the early stages of development as well as growth stages of companies with a synergistic business model to UAT Group subsidiaries.

For more information visit www.uatgroup.com

Investor and Media Contact: UAT Group at info@uatgroup.com

NEITHER THE SECURITIES EXCHANGE COMMISION NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS NEWS RELEASE.

Forward-Looking Information

This news release may include “forward-looking statements” including forecasts, estimates, expectations, and objectives for future operations including but not limited to its ability to conclude a business combination with a third party, sale of assets, return of capital or initial public offering and a secondary listing on the OTC as a result of aforementioned and its ability to fund the exploration of its assets through the raising of equity or debt capital or through funding by a joint venture partner that are

subject to a number of assumptions, risks, and uncertainties, many of which are beyond the control of Umbra Applied Technologies Group including but not limited to capital markets and securities risks and continued development success on technology. There can be and are no actual or implied guarantees that any of the above activities will be completed or completed on terms acceptable to the Company and its shareholders or approved by any regulatory authority having jurisdiction. Such forward-looking information represents management’s best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Umbra Applied Technologies Group does not assume the obligation to update any forward-looking statement, except as required by applicable law.

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Source: https://otcprwire.com/uat-group-inc-acquires-20-of-next-casting-technologies/

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Medical Devices

IAI Announces Medical Assist ELECYLINDER Series

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The main features are easy operation, AVD (acceleration/speed/deceleration) that can be adjusted individually, and high performance. Source: https://infomeddnews.com/iai-announces-medical-assist-elecylinder-series/

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