FWQRC, Quality Professionals

QUALITY PROFESSIONALS

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Today’s topic is about how Quality professionals help organisations to deliver. We explain who they are and how they go about it

  • Everyone in an organisation is responsible for quality – from the CEO to the intern. But not everyone can be a quality expert. It’s important to have people who can provide the knowledge, tools and guidance to help everyone else play their part in pursuing excellence.These people are called quality professionals. Their job is to make sure organisations deliver.
  • Quality professionals come in many guises. Some are generalists, some are specialists. Many will have titles such as quality manager, quality engineer, quality director or assurance manager, while others deal with quality as part of a broader remit. Some are concerned with the delivery of products and services, while some are part of the leadership of an organisation. Some are employed in-house, while others work outside the organisations they deal with.
  • What unites quality professionals is their dedication to protecting and strengthening their organisations by making sure that stakeholders’ needs are met – and ideally, that their expectations are exceeded.

What quality professionals do

To put quality at the heart of their organisations, quality professionals focus on three specific areas, or competencies:

  • Strong governance: This starts with top management expressing a commitment to quality. Effective governance means making sure that the aims of management are crystal clear, that they reflect the requirements of stakeholders, and that the right people, policies and processes are in place to turn them into action.
  • Proper assurance: This ensures that the policies and priorities that have been decided on are being carried out properly, and that whatever is being produced – whether it’s a product, service, or project – is meeting stakeholders’ needs.
  • A culture of improvement: This means continually evaluating the organisation’s performance to improve efficiency, eliminate waste, reduce risk, respond to changes and create new opportunities.

The measure of a quality professional’s success is how well we

  • Protect reputation: avoiding the potentially catastrophic risks of getting things wrong
  • Enhance reputation: maximizing value for our customers and stakeholders
  • Improve profitability: eliminating unnecessary cost and waste and growing revenue
  • Drive change: contributing to the ongoing improvement of the organisation

Quality professionals are recognized by colleagues as

  • Agents for change: transforming processes, behaviour and culture
  • Guardians: protecting the business by identifying appropriate standards for business performance and assuring that they are met
  • Collaborators: working closely with leaders and managers
  • Leaders: creating, managing and improving the organisation’s business process systems
  • Progressive: understanding the realities of managing organisations in dynamic environments
  • Holistic: looking across business functions and hierarchies to advocate a broad process and customer-centric view of the organisation
  • Professional at FWQRC: qualified by professional institute (CQI), the CQI, and bound by a rigorous code of conduct.

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GMP, Supply Chain

MITIGATING RISKS WITH BLACK CHAIN TECHNOLOGY

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This blog is related to how block chain contributes to drug supply management

WHAT IS BLOCK CHAIN?

Block chain, or a distributed ledger, is a way of organisation information is a way that gives all appropriate parties access to the information they need and keeps that information secure from people who should not see it

In terms of quality, block chains can ensure that every part of a supply chain can have assurance that the materials & products moving through it have reached a particular standard passed checks and compiled with necessary regulations

In its simple form,block chain is information that is shared across a group of computers so that if one person updates that information others are able to see it

HOW BLOCK CHAIN CONTRIBUTES TO DRUG SUPPLY-CHAIN MANAGEMENT

Imagine a simple supply chain: Company A produces raw material;company B makes it into a product,while company C sells it. With block chain,company A can alert company B & company C of changes in supply chain-such as overproduction-that they can then use to moderate their manufacturing process. Company B could extend their working hours and sales strategy, while company C could plan a marketing campaign to move the extra product

Sharing decentralized information in this way means that business relationships will become much more flexible,benefiting the participants and requiring no outside help. This can be a highly effective means of self regulation

HOW BUSINESSES ARE USING BLOCK CHAIN IN THEIR SUPPLY CHAIN:

Global research firm, Gartner, predicts that by 2023,some 30% of manaufacturing complanies with revenue of more than $5bn will be using block chain to drive down costs and improve tracebility and transperancy

Block chain as a strategy will force companies to look beyond the boundaries of their own firm & establish shared process and consensus mechanisms with their supply chain partners

CHALLENGES OF THE MODEL

  • The benefits are great,but they may come at a cost
  • Block chain represents a challenge for businesses “Companies that have an ageing information technology infrastructure will struggle to interact effectively with digitally native companies
  • Tech companies have a responsibility to make the user experience as easy & seamless as possible for everyone in the supply chain

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Agriculture, Food, Regulatory Focus News Letter, Your Partner

FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products

Hi,Welcome to FWQRC Regulatory Focus News Letter…

Today, in recognition of January 2020 as National Biotechnology Month, the U.S. Food and Drug Administration, the Department of Agriculture and the Environmental Protection Agency launched a Unified Website for Biotechnology Regulation. The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

“This is a time of unprecedented scientific innovation. Agricultural biotechnology promises to bring dynamic new products to the marketplace,” said FDA Commissioner Stephen Hahn, M.D. “At the FDA, we are committed to fostering flexible, risk-based approaches in this field while upholding our mission of protecting and promoting both human and animal health and animal well-being, for example by reducing their susceptibility to diseases like novel influenzas and resistance to zoonotic or foreign animal diseases. Our approach balances our internationally respected, science-based review standards with our ongoing risk-based regulatory approaches to ensure the safety of our food supply.”

The Unified Website for Biotechnology Regulation describes the federal review process for certain biotechnology products and allows users to submit questions to the three agencies. The goals of this website are to provide enhanced customer service to innovators and developers, while ensuring Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotechnology innovations.

In October 2018, the FDA announced its Plant and Animal Biotechnology Innovation Action Plan, which focuses on the agency’s risk-based regulatory approach. This approach will help secure confidence in the reliability and performance of plant and animal-based innovative products for consumers and America’s global trading partners. Making sure these products are safe is critical to maintaining consumer and commercial confidence in them and will help them to realize their full potential benefits for human and animal health.

The FDA uses a flexible, risk-based approach to the oversight of plant- and animal- derived products of biotechnology, focusing on safety and, where applicable, effectiveness. The agency’s approach includes, when appropriate, updating and clarifying science-based policies to support innovation and ensure that our regulatory processes are efficient, predictable, and proportionate to risk.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

COSMETICS, GMP, Healthcare Institutions, Life Sciences, Medical Devices, Regulatory Focus News Letter

Cosmetic Registration Reports

Hi, Welcome to FWQRC Regulatory Focus News Letter

About Blog FWQRC Regulatory focus pharma news, views and analysis of healthcare in a rapidly changing world. Not only do we keep you connected with the latest trends in pharma, we can also help you develop and bring to life your own thoughts, ideas and inspirations to enable you and your business to become key pharma influencers

The information in the tables below is a monthly report of activity in FDA’s Voluntary Cosmetic Registration Program (VCRP)

VCRP Monthly Status Report

Because the law does not require cosmetic firms to register their establishments or file their product formulations with FDA, participation in this program is voluntary. For this reason, the information below does not indicate the total number of companies manufacturing or marketing cosmetics in this country, or all cosmetic products on the market.

Activity for December 2019

  • Number of online accounts activated this month: 103
  • Number of products filed this month: 593
  • Total activity since the launch of the new online system, September 20, 2018
  • Number of active online accounts: 2,816
  • Number of active cosmetic establishment registrations: 1,395
  • Number of labelers that have filed product formulations*: 650
  • Number of filed products: 8,333
  • Number of product formulations discontinued**: 373
  • Number of product formulations rejected***: 958
  • Total activity since the VCRP was established, in 1972
  • Number of active cosmetic establishment registrations: 4,392
  • Number of labelers that have filed product formulations*: 3,071
  • Number of active products on file: 68,838
  • Number of product formulations discontinued**: 82,094
  • Number of product formulations rejected***: 5,101
Guidelines, Healthcare Institutions, Life Sciences, Regulatory Focus News Letter

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

HI, Welcome to FWQRC Regulatory Focus News letter

Today’s topic is about the new treatment option for patients with HER2-positive breast cancer approved by FDA

The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, meaning that the drug targets the changes in HER2 that help the cancer grow, divide and spread, and is linked to a topoisomerise inhibitor, which is a chemical compound that is toxic to cancer cells.

“There have been many advances in the development of drugs for HER2-positive breast cancer since the introduction of Herceptin (trastuzumab) in 1998. The approval of Enhertu represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Drug development in the area of targeted therapies builds on our scientific understanding of malignant diseases not only in breast cancer, but in multiple other diseases.”

HER2-positive breast cancer is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. Approximately one of every five breast cancers have a gene mutation in the cancer cells that makes an excess of the HER2 protein. HER2-positive breast cancers are an aggressive type of breast cancer.

Enhertu’s approval was based on the results of a clinical trial enrolling 184 female patients with HER2-positive, unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies in the metastatic setting. These patients were heavily pretreated in the metastatic setting, receiving between two and 17 therapies prior to receiving Enhertu. Patients in the clinical trial received Enhertu every three weeks and tumor imagining was obtained every six weeks. The overall response rate was 60.3%, which reflects the percentage of patients that had a certain amount of tumor shrinkage with a median duration of response of 14.8 months.
The prescribing information for Enhertu includes a Boxed Warning to advise health care professionals and patients about the risk of interstitial lung disease (a group of lung conditions that causes scarring of lung tissues) and embryo-fetal toxicity. Interstitial lung disease and pneumonitis (inflammation of lung tissue), including cases resulting in death, have been reported with Enhertu. Health care professionals should monitor for and promptly investigate signs and symptoms including cough, dyspnea (difficult or labored breathing), fever and other new or worsening respiratory symptoms. If these symptoms arise, Enhertu may need to be withheld, the dose reduced or permanently discontinued. Women who are pregnant should not take Enhertu because it may cause harm to a developing fetus or newborn baby, or cause delivery complications. The FDA advises health care professionals to tell females of reproductive age, and males with a female partner of reproductive potential, to use effective contraception during treatment with Enhertu.

The most common side effects for patients taking Enhertu were nausea, fatigue, vomiting, alopecia (hair loss), constipation, decreased appetite, anemia (hemoglobin in blood is below the reference range), decreased neutrophil count (white blood cells that help lead your body’s immune system response to fight infection), diarrhea, leukopenia (other white blood cells that help the immune system), cough and decreased platelet count (component of blood whose function is to react to bleeding from blood vessel injury by clumping, thereby initiating a blood clot). Decreased neutrophil count is a potentially serious and common side effect as described in the Medication Guide. Patients treated with Enhertu may be at increased risk of developing left ventricular dysfunction, which occurs when the heart is unable to pump blood effectively to the body, as this has been seen with other HER2-directed therapies for breast cancer.

Enhertu was granted Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients. Further clinical trials may be required to verify and describe Enhertu’s clinical benefit.
The FDA granted this application Breakthrough Therapy designation, which expedites the development and review of drugs that are intended to treat a serious condition, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Enhertu was also granted Fast Track designation, which expedites the review of drugs to treat serious conditions and fill an unmet medical need. This application was approved three months prior to the FDA goal date.

The FDA granted the approval of Enhertu to Daiichi Sankyo.

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Regulatory Focus News Letter, Your Partner

National Drug Code(NDC)

Hi, Welcome to FWQRC Regulatory focus News Letter….

Here we are going to review the historic step taken by Trump Administration to lower U.S. prescription drug prices

Proposed rule could allow certain prescription drugs to be imported from Canada; draft guidance explains how manufacturers could import drugs, biological products originally intended for sale in another country

Today, President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
The NPRM issued today is the first step in implementing a provision of federal law that would allow for the importation of certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer. The draft guidance issued today describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign country is, in fact, an FDA-approved drug product, including that it is manufactured in accordance with the FDA-approved application.

“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Health and Human Services Secretary Alex Azar. “These are historic actions by HHS and the FDA, and they represent the bold nature of President Trump’s agenda for lowering drug costs. The President has recognized the opportunity to lower costs for American patients through safe importation, and we at HHS and FDA are delivering on that possibility through a safe, commonsense approach.”

The NPRM would allow states and certain other non-federal government entities to submit importation program proposals to the FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity. Referred to as Section 804 Importation Programs, these programs would be authorized by the FDA to manage the importation of certain prescription drugs that are approved in Canada and also meet the conditions in an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labeling prior to importation and undergo testing for authenticity, degradation, and to ensure that the drugs meet established specifications and standards. Notably, these programs would also have to demonstrate significant cost reductions to the American consumer.

“The FDA continues to assess and act on multiple opportunities to promote competition that can, in turn, help reduce drug prices and improve access to medicines for Americans,” said Assistant Secretary for Health Brett Giroir. “The proposed rule and draft guidance include procedures intended to protect the public’s health and safety. We look forward to receiving public comment on these draft policies, and we will take timely comments into account as we work to finalize the rule and guidance. Our ultimate goal is to provide a robust program that clearly lays out procedures to import drugs that could provide lower prices while also maintaining the high quality Americans expect.”

Of note, the draft guidance describes procedures drug manufacturers could follow to obtain an additional National Drug Code (NDC) for certain FDA-approved prescription drugs, including biological products, that were originally manufactured, and intended to be marketed, in a foreign country. The use of an additional NDC would allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require.

The draft guidance also recommends that the drug manufacturer include a statement on the product’s label and in the prescribing information to assist pharmacists to accurately identify, dispense and bill for these products. Prescription drugs, including biological products, imported under the pathway described in the draft guidance could be available to patients in a variety of settings, including hospitals, health care providers’ offices, or licensed U.S. pharmacies, and would include the FDA-approved labeling (including prescribing information).

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register

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