Quality Culture, Regulatory Focus News Letter, Your Partner

DEVELOPMENT OF A QUALITY CULTURE

Hi, Greetings from FWQRC……

Today’s topic is about the development of a Quality Culture and the supporting role of international standard development

Quality Culture is a term being discussed with increasing regulatory among quality professionals as well as more widely outside of the quality profession, as organisations and governments consider continuous challenges including productivity, competitive strategy and reputation protection.Within a quality culture, everyone is involved in the ongoing pursuit of excellence

Pharmaceutical culture of quality

Each worker or team is both a supplier & customer within their organisation and takes responsibility for the quality of their output. In this setting, there is no need to check the final products as an incremental review has occurred on an ongoing basis at each stage

Conversely, the absence of a quality culture is likely to be characterized by an absence of individual or team responsibility and the need for costly & time consuming inspection and test regimes which add little value

Conclusion: Given the more elusive nature of culture compared to other facts of organisation life, it is not unreasonable for individuals to look for external sources of guidance. Assistance may be required to understand current culture, determine that culture which might best address requirements and to help define & deliver actions to support the quality culture journey.

Write to fwqrcservices@gmail.com to understand your organisations current culture, determine that culture and deliver actions to support the quality culture

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.

Your Partner

New year greetings

We wish that all your wishes are fulfilled this year.

Stay connected with FWQRC…

Food, Healthcare Institutions, Life Sciences, Regulatory Focus News Letter

Investigation of Listeria monocytogenes

Welcome to FWQRC Regulatory focus news LetterHere we are going to review on the Outbreak Investigation of Listeria monocytogenes Linked to Hard-Boiled Eggs, December 2019FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to foods that contain hard-boiled eggs. On December 20, 2019, Almark Foods recalled and suspended production of hard-boiled and peeled eggs in pails due to the potential for contamination with Listeria monocytogenes. These hard-boiledand peeled eggs were sold in pails under the following names: Rainbow Select Hard-cooked Eggs, Rainbow Select Hard-cooked Eggs in Vinegar, Nic’s Salad Hard-boiled Eggs, Almark Hard-cooked Eggs, and Sutherland Select Hard-cooked Eggs. A full list of recalled products is included below.RecommendationFood processors, restaurants, and retailers should not sell or serve any of the recalled hard-boiled and peeled eggs in pails from Almark Foods. These products were not sold directly to consumers.Additionally, FDA recommends that food processors, restaurants and retailers who have received Almark Foods bulk, fresh hard-boiled eggs, use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross-contamination.Background:As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states. In interviews, ill people answered questions about the foods they ate and other exposures in the month before they became ill. Of the five people for whom information was available, four reported eating products containing eggs. Three of these people reported eating hard-boiled eggs in deli salads purchased from grocery stores and in salads eaten at restaurants. Illnesses started on dates ranging from April 10, 2017 to November 12, 2019.Additionally, based on whole-genome sequencing, the Listeria monocytogenes found in environmental samples collected at the firm’s processing facility during an FDA inspection conducted in February 2019 is a genetic match to the outbreak strain. FDA is conducting additional inspections and sampling. Almark Foods has been cooperating with the ongoing investigation and announced a voluntary recall of hard-boiled and peeled eggs in pails on December 20, 2019.This outbreak strain was found during environmental sampling in 2017 of one other food facility. That facility is not currently handling food and ceased operation in 2018.Thank you for viewing FWQRC blogs….

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

Thank you for viewing FWQRC newsletters……..

Guidelines, Your Partner

Some Medicines and Driving Don’t Mix

Hi, Welcome to FWQRC News Letter

Here we are going to review on medicines that might affect driving

Although most medications won’t affect your ability to drive, some prescription and nonprescription medicines can have side effects and cause reactions that may make it unsafe to drive, including:

  • sleepiness/drowsiness
  • blurred vision
  • dizziness
  • slowed movement
  • fainting
  • inability to focus or pay attention
  • nausea
  • excitability

Additionally, we know that CBD can cause sleepiness, sedation and lethargy, based on data from the approved prescription CBD drug. Because of these side effects, consumers should use caution if planning on operating a motor vehicle after consuming any CBD products.

Medicines That Might Affect Driving

Knowing how your medications — or any combination of them — affect your ability to drive is a safety measure. Some drugs that could make it dangerous to drive include:

  • opioid pain relievers
  • prescription drugs for anxiety (for example, benzodiazepines)
  • anti-seizure drugs (antiepileptic drugs)
  • antipsychotic drugs
  • some antidepressants
  • products containing codeine
  • some cold remedies and allergy products, such as antihistamines (both prescription and OTC)
  • sleeping pills
  • muscle relaxants
  • medicines that treat or control symptoms of diarrhea
  • medicines that treat or prevent symptoms of motion sickness
  • diet pills, “stay awake” drugs, and other medications with stimulants (e.g., caffeine, ephedrine, pseudoephedrine)
  • Taking Cannabidiol (CBD) Products and Driving Can Be Dangerous

Last year the agency approved a prescription CBD drug, Epidiolex, for the treatment of two rare and life-threatening seizure disorders in children. The FDA has not approved any other CBD products. Unlike drug products approved by the FDA, unapproved CBD drug products have not been subject to any FDA review. 

Moreover, there has been no FDA evaluation regarding whether unapproved CBD drug products are safe and effective to treat a particular disease or condition, what the proper dosage is, how they could interact with other drugs, foods or cosmetics, or whether they have dangerous side effects or other safety concerns.

But we do know that CBD can cause sleepiness, sedation and lethargy, based on data from the approved prescription drug. Because of these side effects, consumers should use caution if planning on operating a motor vehicle after consuming any CBD products.

We urge you to obtain more information about CBD by visiting: What You Need to Know About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.

Some Sleep Medicines Can Impair You, Even the Next Morning

People with insomnia have trouble falling or staying asleep. Many take medicines to help sleep. Come morning, though, some sleep medicines could make you less able to perform activities for which you must be fully alert, including driving.

A common ingredient in a widely prescribed sleep medication is zolpidem, which belongs to a class of medications called sedative-hypnotics. The FDA has found that medicines containing zolpidem, especially extended release forms, can impair driving ability and other activities the next morning.

Zolpidem immediate and extended-release forms are marketed as generic drugs and under these brand names:

  • Ambien and Ambien CR (oral tablet)
  • Edluar (tablet placed under the tongue)
  • Intermezzo (tablet placed under the tongue)
  • Zolpimist (oral spray)

People who take sleep medicines should talk to their health care professional about ways to take the lowest effective dose. Don’t assume that non-prescription sleep medicines are necessarily safer alternatives. The FDA is also evaluating the risk of next-day impairment with other insomnia drugs, both prescription and OTC versions.

Allergy Medicines Can Affect Your Ability to Drive

For allergy sufferers, medications containing antihistamines can help relieve many different types of allergies, including hay fever. But these medicines may interfere with driving and operating heavy machinery (including driving a car).External Link Disclaimer Antihistamines can slow your reaction time, make it hard to focus or think clearly, and may cause mild confusion even if you don’t feel drowsy.

Read the OTC Drug Facts label of your medicine and understand the warnings before using it. Also, avoid drinking alcohol or taking sleep medications while using some antihistamines. Those combinations can increase the sedative effects of antihistamines.

How to Avoid Driving Impaired

You can still drive safely while taking most medications. Talk to your health care provider about possible side effects. For example, some antihistamines and sleep medications work for longer periods than others. You might feel the sedating effects of these medications for some time after you’ve taken them, and maybe even into the next day.

Doctors and pharmacists can tell you about known side effects of medications, including those that interfere with driving. You can also request printed information about the side effects of any new medicine.

To manage or minimize side effects while driving, your health care provider may be able to adjust your dose, adjust the timing of when you take the medicine, or change the medicine to one that causes fewer side effects for you.

Here are some more tips:

  • Always follow directions for use and read warnings on medication packaging, or handouts provided by the pharmacy.
  • Don’t stop using your medicine unless your prescriber tells you to.
  • Tell your health care provider about all the products you are taking, including prescription, OTC, and herbal products. Also, let them know about any reactions you experience.

Thank you for visiting FWQRC blogs…

Contact FWQRC™ for GMP Training, Auditing by QP, eCTD, GAP Analysis, Risk Assessment, CAPA, CSV, Method development/Validation, ADE/PDE Values, Facility & Product Registrations