QbD Development Process Evaluating Critical Steps

The selection of robust process parameters for Quality designs, and how to establish criteria to measure and discernable observances.

  • How to Build quality, safety, and efficacy into the manufacture of drug product
  • The ICH guidelines for pharmaceutical manufacturing
  • Risk-based, modern pharmaceutical manufacturing
  • Understanding Target Quality Profile, Critical Quality Attributes
  • Process parameters and design experiments
  • Regulatory concerns FDA and EMA on QbD

To establish a procedure for the proper assessment of product and process design, Also, to align evaluation of product quality standards for chemistry manufacturing and controls (CMC) review and to maintain quality standards per Office of Pharmaceutical Science (OPS)

It should be noted that OPS is responsible for assuring that the quality of drug products for the entire pharmaceutical industry follow uniform policy and review processes during drug product development (the manufacture and formulation).

Therefore, it is incumbent on all personnel involved with the preparation of documentation for subsequent submission to the regulatory authority recognize the importance of creating and maintaining a clear scientific and sound approach for all products.

  • Quality target product profile (QTPP) forms the basis for design and the development of the product. Considerations for the Quality Target Product Profile (ICH guideline Q8 R2)
  • Critical quality attributes (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality
  • Process Analytical Technology (PAT) which is a Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
  • Risk Assessment (RA)one can recognizing critical attributes that are going to affect final quality of product

Process Evaluating Critical Steps

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GMP Expectations for Products Used in Early Phase IND Studies

GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

  • Discussion of the elements found in the guidance document for Phase 1 material
  • What to do at really early stages
  • What about special IND studies?
  • What about preclinical studies?
  • Varying GMP activities that depend upon the nature of the IND product
  • What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
  • What to do about QC activities such as instrument qualification, method validation, and process validation

These guidelines remove some of the problems https://goo.gl/9qYuLa

Dread the gym? This smart mirror delivers your fitness fix at home

We visited Mirror’s HQ in NYC to test it out and to see if it’s really worth cancelling that gym membership for.

You’re probably thinking that there’s plenty of at-home fitness equipment on the market, but this one isn’t an eyesore. Unlike a spin bike or treadmill, it also brings you a huge variety of exercises from yoga to barre, and even weight training. But at $1,500, Mirror is an investment you want to be sure about. We visited Mirror’s HQ in NYC to test it out and to see if it’s really worth cancelling that gym membership for.

Looks sleek and high-end

For $1,500, one would hope the product not only works well but looks nice too — especially if it’s hanging in the middle of your home. It does. When we saw the product ahead of its debut in September, we were blown away. At first glance it appears to be a normal mirror with an extremely sleek look framed in dark, carbon steel, but there’s a mineral bronze powder-coated LCD inside.

At the top is a 5-megapixel front-facing camera (which will be used for personal training classes in 2019) that comes with a convenient cover you can slide on and off, for those worried about privacy. It’s a little bulky and distracting, and takes away from the streamlined look of it. The 40-inch display boasts a 1080p resolution, and in our demo, content looked crisp and bright on the screen. To hear your workouts loud and clear, there are also two 10-watt speakers built in.

There’s no touchscreen capability, which might be for the best if you imagine the potential for fingerprints and smudges. With dual-band Bluetooth and Wi-Fi, everything is connected from Mirror’s app on your smartphone. That way, you can also sync a heart-rate monitor or your Apple Watch to see your beats per minute in real time during workouts. Unfortunately, the app is compatible only with iOS devices for now.

Click here to continue to build own body shapes

The [Ultimate Guide] To Medical Device Inspection

I want to present the ultimate guide to medical device inspection, which I believe is going to live up to just what I am calling it: the ultimate guide to medical device inspection.

A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.

Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection? Fact is, a medical device inspection’s stringency is a little overrated. Am I not contradicting myself? On the surface, yes, but scratch a bit, and you will realize the truth of what I am saying.

Yes, medical device inspections are extremely difficult to the point of being scary. But the fundamental question is, for whom? A medical device inspection is a difficult one for only those who are unprepared for it. In other words, a medical device inspection is just like a highly rated competitive exam: it is tough if you are unprepared and manageable if you are prepared.

So, in what way can a medical device manufacturer prepare for a medical device examination? I want to present the ultimate guide to medical device inspection, which I believe is going to live up to just what I am calling it: the ultimate guide to medical device inspection.

The basis to a medical device inspection is just one mantra: prepare, prepare and prepare. I already know it and I don’t need you to tell me this, you may say. But how to prepare and what to prepare for is the question. I will try to make my ultimate guide to medical device inspection as comprehensive as I can and will try to shed as much light on as many areas of it as I can, while trying to keep it simple.

Conceptualization

Let us begin at the beginning. Some medical devices are designed newly. Many build on what is already there in the market and some are completely off the block. The first step to my ultimate guide to medical device inspection is to understand this aspect of a medical device. Is your device a new one or is it being developed based on an existing device’s core? Many devices alter or extend an existing one to stretch its uses to a new or untapped market. The entire nature of the medical device inspection can depend on this nature of the medical device. So, classifying your medical device into its right slot is the first step in this ultimate guide to medical device inspection. Conceptualizing what your medical device is like is half the work done.

Regulations!

Regulations are at the heart of medical device inspections. All inspections look primarily for the extent of compliance to regulations. In perhaps no other industry is regulation of such vital importance than in the field of medical devices. Getting the regulations right is the foundation of a successful medical device inspection and quite easily qualifies in the ultimate guide to medical device inspection. Companies have enormous resources in the form of FDA literature (or that of other regulatory bodies if the product is marketed in those jurisdictions) and expert guidance.

My sincere exhortation: please do not hold back your purse strings in this most important of areas. If you try to economize and satisfy yourself that you have saved a few dollars here, think of what you will be required to cough up if your device fails to meet regulatory standards. The penalties are of such order that you may even have to shut shop like so many others that have met the same fate. Make sure the regulations are adhered to each and every stage. The consequences of staying compliant are simply too many and all of them are of a positive nature.

Keep a very sharp eye on Design Controls

Design Controls constitute the next point in the ultimate guide to medical device inspection. This is another of the areas in which the FDA is unsparing when it comes to penalizing medical devices companies that don’t meet the requirements. Learn all the intricacies of Design Controls and understand the criticality of documentation in Design Controls. In addition to helping you to meet regulatory standards, it also makes your own life easier. Documentation enables you to quickly track any activity that the inspector may want to examine. It helps you guarantee and assure your activity at every stage. This diagram is neatly indicative of what the FDA expects the Design Control flow to be like:

This link https://goo.gl/5Yn6MF has more on this topic for your reference

Medical Wearable Devices Health Technology [Fads or the Future]

The fitness wearable company has adopted Google Cloud for Healthcare application programming interfaces (APIs) in a bid to make data sharing more secure.

The wearable health technology craze looks like it’s here to stay but some devices are proving more useful to the medical industry than others. Which of the most talked about devices are fads and which could be the future?

As the wearable health technology market continues to grow it can be hard to distinguish the trendy consumer devices from those with useful medical applications. From the debate over smart watches to the latest wearable MRI scanner, here’s a roundup of some of the most talked about wearables. Many of them are pointing the way to the future of patient care.

wear electronics

In the ever growing wearable health technology market, Fitbit is arguably the most well-known brand. Extremely popular with consumers, fitness tracking Fitbit watches are not a favourite among medical professionals due to claims that the patient data collected is not accurate enough for medical assertions to be made. However, Fitbit remains determined to break into the healthcare market and partnered with Google earlier this year to improve the ability of its devices to share data with medical professionals. The fitness wearable company has adopted Google Cloud for Healthcare application programming interfaces (APIs) in a bid to make data sharing more secure.

The more medically trusted smart watches include the FDA-approved Empatica smartwatch, called Embrace, which is designed to monitor seizures. The AI-powered device uses advanced machine learning to check for grand mal or generalised tonic-clonic seizures and can send instant alerts to caregivers.

cropped-future-of-integrated-health-960x329px

Continuous glucose monitors (CGMs) are becoming increasingly popular with diabetic patients, who can wear the devices day and night to keep an eye on their glucose levels. The popularity of the devices lies in the fact that a patient can view their glucose levels with a quick glance and only have to use a finger prick blood test twice a day to check that the readings on both devices are similar.

Real-time glucose levels help patients make more informed choices about the types of food, physical activities and medication they require throughout the day. CGMs work by using a tiny sensor inserted under a patient’s skin which tests interstitial glucose levels every few minutes and sends this information to a monitor or smartphone. Patients receive alerts when their glucose levels need to be adjusted.

Devices like the Dexcom G6 are popular because they claim to negate the need for patients to use finger sticks.

Diagnostic wearables

No matter how advanced healthcare is becoming there is always an occasion when healthcare professionals just aren’t sure what is wrong with a patient. This is where diagnostic wearables come in.  Australian National University (ANU) researchers recently developed optical sensors that can be used in wearable medical devices to diagnose various diseases in real-time. The sensors measure very small concentrations of metabolite gases, which are emitted through human skin and breath, and use these measurements to detect biomarkers which can indicate a variety of diseases.

at-home-sleep-trackers

Other new diagnostic wearables include body-worn sensors that can assess gait and potentially detect Alzheimer’s disease early. Diagnostic technologies like this definitely have a future as the healthcare industry continues to look for ways of diagnosing chronic conditions earlier.

Cardiac monitors

Wearable imaging

More interesting topic if you miss you never understand http://bit.ly/2MTQpvQ

Few Things [Nobody] Told You About Good Clinical Practice

The most important aim of GCP is to ensure that the data clinical trials generate, in meeting scientific standards

Good Clinical Practice (GCP) is a set of international standards meant for entities that conduct clinical trials. This set of standards, formulated by the International Conference on Harmonization (ICH), when implemented into clinical trials involving human subjects, seeks to ensure the protection of the humans involved in the research, as well as to bring about transparency in the methods of clinical practice. The efficacy and safety of the clinical product these trials seek to produce is another of the desired outcomes of GCP. GCP has been formulated to set standards and protocols that ensure the efficacy of the therapies into a larger population. The most important aim of GCP is to ensure that the data clinical trials generate, in meeting scientific standards, are:

  • Accurate
  • Verifiable

Now, the challenges associated with GCP implementation

The intention behind the formation of GCP guidelines is beyond suspicion. No person in his or her right mind can argue about the beneficial intent of these guidelines. This said, there are a few challenges associated with GCP implementation. A look at some of the things nobody tells you about GCP before you get started:

Interpretation of the documents

The first important aspect of GCP nobody tells you about pertains to interpretation. This is at the heart of challenges concerning GCP. Good Clinical Practice is an exact science whose practice is open to subjectivity. This is one of the major oxymoronic aspects of GCP. This is because while GCP sets out the standards that clinical sites are required to comply with; it does not state which method to adapt. These standards are codified and located in multiple locations of the GCP standard, which means that those involved in research have to tome over absolutely every bit of the standard before getting down to researching.

principle-of-good-clinical-practice-4-638

As a first step, in the US, the clinical site starting the research has to obtain clearance for this research by signing what is called Form 1572, which is an FDA form in which the investigator has to state all the intent, scope, SOPs, and all other such aspects of the trial. To do this, the Principal Investigator (PI) should read the document upside down, in a manner of speaking, because this is the clearest guideline to what the research is going to do. Although not impossible or unachievable, this aspect of clinical trials is a challenge nevertheless.

Literature review

Literature review is another tough nut to crack for ensuring GCP adherence. This is so because although it appears more like just a formality, sufficient midnight oil has to be burnt to produce a literature review that meets the GCP expectations of the regulatory authorities. All the details of GCP guidelines laid out by such international standards and declarations as the Helsinki Declaration, the Common Rule, the Belmont Report, the World Health Organization guidelines on best clinical practices, and the various CFRs issued by the FDA, have to be taken into consideration. Again, this is something PIs get assistance to carrying out, but is a challenge no doubt.

Getting the site awarded

The actual way in which the recruitment of volunteers, or subjects as they are called, takes place is another of the many things nobody tells you about GCP. It starts with filling up the Investigator Interest Questionnaire. A synonym for a feasibility survey, this is a form from which the clinical research sites are allocated for study. Although done online, this is quite an elaborate procedure, to which one needs quite a high level of understanding of how the system works.

A site qualification visit that follows next is also a critical meeting that the Principal Investigator has with the Clinical Research Associate. At this meeting, all the ingredients that go into the clinical research, such as the purpose and the product that is sought to be obtained, the demography of the subjects, the state and fitness of the instruments, the mode of the trial, the infrastructure of the site and a million other questions have to be satisfactorily answered. It is only following all these that the CRA makes up her mind about awarding the clinical site to the organization.

There are challenges, but don’t let them deter you

It needs mentioning that these challenges are not universal in nature. What is a problem in one jurisdiction or GCP site need not be so in another. Another important aspect that needs to be taken into consideration is the fact that these are not stumbling blocks, but steps aimed at ensuring that the purpose for which GCP was enacted is being met at every clinical trial. So, this should not put anyone off.

These things that nobody tells you about Good Clinical Practice are not meant to scare you from carrying out research which could prove beneficial in many ways, but to just let you know that there are some factors that need to be taken into consideration before plunging into a clinical research.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2794015/

https://gh.bmj.com/content/bmjgh/1/3/e000122.full.pdf

https://medium.com/@TheRealDanSfera/clinical-research-monitoring-101-the-basics-you-need-to-understand-to-become-a-clinical-research-c2184ec4df6b

https://cdn2.hubspot.net/hub/149400/file-18012806-pdf/docs/mc-n_good-clinical-practice-from-review-to-application.pdf

Short-term [Health Plans]: A junk option to an actual drawback

Here is why I think states can and should take quick action to protect consumers.

After failing to overturn most of the Affordable Care Act in a very public fight, President Donald Trump has been steadily working behind the scenes to further destabilize former President Barack Obama’s signature achievement. A major component in this effort has been an activity called rule-making, the administrative implementation of statutes by federal agencies like the Department of Health and Human Services.

Most recently, citing excessive consumer costs, the Trump administration issued regulations to vastly expand the availability of short-term, limited duration insurance plans.

While the cost of health care is one of the overwhelming problems in the American health care system, short-term health plans do nothing to alter the underlying causes. Indeed, these plans may cause great harm to individual consumers while simultaneously threatening the viability of many states’ insurance markets. Having studied the U.S. health care market for years, here is why I think states can and should take quick action to protect consumers.

doctor-futuristic-medical-concept-pressing-button-89989642

Comparing crab apples and oranges

Short-term, limited duration insurance plans, by definition, provide insurance coverage for a short, limited period. Since being regulated by the Health Insurance Portability Act of 1996 (HIPAA), this has meant for less than one year. Sold at least since the 1970s, they were offered as an alternative to major medical insurance intended for individuals with temporary and transitional insurance needs such as recent college graduates or those in between jobs.

However, after passage of the Affordable Care Act further concerns emerged over the misuse and mismarketing of these kinds of plans. As a result, the Obama administration restricted their duration to three months.

In addition to being shorter in duration, these policies’ benefits tend to also be much skimpier than for those plans sold on the Affordable Care Act’s marketplaces. For example, plans often do not cover crucial services such as prescription drugs, maternity care, or major emergencies like cancer. Equally problematic, even those benefits covered come with high deductibles, strict limitations, and annual and lifetime coverage limits.

It is important to note that short-term health plans are also not subject to any of the consumer protections established by the Affordable Care Act. This means, for example, that insurers can set premiums, or even refuse to sell to an individual, based on a person’s medical history. Moreover, consumers must update their health status every time they seek to purchase coverage.

Crucially, short-term health plans have shown to be particularly discriminatory against women. For one, women are charged higher premiums. Moreover, they are likely to be disproportionately affected by medical underwriting for pre-existing conditions like domestic and sexual abuse and pre- and postnatal treatment.

Expansion of short-term health plans https://goo.gl/MTSEZP