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


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

This Article Will Make Your Environmental Compliance Amazing: Read or Miss Out!

Both EPA and OSHA have tons of information about every aspect of environmental compliance. They are handy and easy to understand.

Environmental compliance is a critical requirement for workplaces in many parts of the world. In the US, this aspect of compliance is undertaken by the Environmental Protection Agency (EPA) in conjunction with the Occupational Safety and Health Administration (OSHA). These agencies coordinate with each other to ensure that environmental hazards are kept within specified limits so that they don’t affect the workforce or cause damage to the environment beyond prescribed norms or levels.

An example of the way by which these two agencies coordinate is the one that relates to the control of accidental release of chemicals from designated workplaces that may have an adverse impact on employees, the environment or the general public. While OSHA is given the responsibility of ensuring that chemical releases do not affect workers in the workplace under Sec. 304; Sec. 112 (R) of the EPA’s Clean Air Act describes how to protect the general public from the effects of such hazards.

In areas such as chemical accident prevention, the EPA and OSHA work closely in a number of designated areas, which include:

  • Helping companies that come under their regulatory guidelines to ensure compliance
  • Guiding and interpreting the regulations
  • Coordinating in strategies and actions relating to enforcement and compliance
  • Putting in place and implementing mechanisms for sharing information.

The fact that two federal agencies work in tandem to ensure environmental compliance makes this a serious issue that companies can ignore only at their own peril. The understanding of facts such as this goes a long way in ensuring environmental compliance because it drives home the criticality of ensuring environmental compliance.

Simple, yet effective tips for ensuring environmental compliance

This article will make your environmental compliance amazing: it offers simple, down-to-earth tips on how to ensure environmental compliance rather than drilling down complex and incomprehensible insights. These are some of the steps you could take to ensure environmental compliance:

Be in touch with the government agencies

This is the most obvious, yet the most effective way of ensuring environmental compliance. It is the governmental agencies that are responsible for ensuring compliance. So, who could be a better guide to help you with yours? Directly interacting with agencies such as EPA and OSHA will help you take the proper steps right in consultation with them. Also, make ample and maximum use of the resources that are available all over the Net. Both EPA and OSHA have tons of information about every aspect of environmental compliance. They are handy and easy to understand.

Take expert help

Experts are what they are: very knowledgeable professionals in their field. Taking the help of an environmental compliance expert will help you stay clear of the provisions relating to environmental compliance. Selecting the appropriate one in this connected world should never be an issue.

Implement compliance software

Many software applications that not only guide you in compliance but also carry out most of the requirements are available in the market. This type of software application is very helpful in taking the pain and the guesswork out of environmental compliance implementation. Agreed, the cost of buying, installing and running these software applications can be expensive. Yet, this cost neutralizes over the long run. More importantly, this cost is very small in relation to the cost of noncompliance.

Train your employees

No understanding of the regulations or implementation of any other tip is of any value unless the employees become an active part and stakeholders in ensuring compliance with the environmental regulations. Employees are the central players in environmental compliance. It is primarily for them that all the regulations are made. These are the core stakeholders in ensuring environmental compliance. The key is to make understand the benefits they get by implementing and complying with the environmental guidelines. This is when they can become active players in the entire endeavor.

Pump Up Your Sales with Some Remarkable Lean Management Tactics

Spending a few productive minutes with HR is likely to save you valuable time on three or four unproductive interviews running into hours.

Lean management for sales? Isn’t that kind of oxymoronic? We have been told all along that lean management is ideal for areas such as manufacturing, services, operations and supply chain since it is essentially built upon minimalization of waste. How does sales fit into this picture?

Fact is, it does. You can pump up your sales with some remarkable lean management tactics. As we know, lean management is a set of practices that helps an organization to optimize its revenues while keeping its resources at a minimum by avoiding wastage at every possible point. Lean management is primarily about creating value by identifying the core points at which wastage occurs and plugging them in every viable way.

Lean management consists of streamlining and harmonizing the points of productivity across the areas of service, technology, manufacturing and many others. Now, this understanding is necessary to derive a grasp of how you can pump up your sales with these remarkable lean management tactics. So, what is in all this for sales is a question some people might ask, in just the way many others have. They ask, with quite some justification, if lean management can work in an area that offers sales incentives to its staff to reward and motivate them.

How does lean management work for sales?

Let us try to understand how lean management concepts go for sales:

The starting point, in fact the real point, to how to pump up your sales with some remarkable lean management tactics is to realize that inculcating activities in which waste does not occur is not restricted to areas with which lean has come to be identified. Simple: you can adapt lean principles into all the areas of sales starting from interviewing candidates for the job.

Let me explain: when you shortlist candidates for interviewing to be brought into the sales team, whether you realize it or not, the organization spends a lot of unnecessary resources on arranging the interview. These could range from calling up the candidate, spending time on the interview and deciding about her suitability. What if the candidate is rejected? Haven’t you wasted a lot in terms of resources? Haven’t you wasted your manager’s time, the expense on phoning or any other such items?

Adapt the same lean thinking for sales as well

Pumping up your sales with some remarkable lean management tactics consists of looking at all these as wasteful activities. Well, you may be wondering if I am saying that interviewing candidates is a wasteful activity. It certainly isn’t. But spending a lot of time and money on interviewing the wrong candidate certainly is!

If you keep the lean principles in mind, you would ask HR to shortlist a more suitable candidate, where the chances of rejecting are fewer, and you could be doing with a lot less waste of your time. Spending a few productive minutes with HR is likely to save you valuable time on three or four unproductive interviews running into hours.

And what about lean practices during the sales itself? Setting up the right time for the sales appointment, avoiding travel on a call that is not likely to result in a deal, avoiding expensive trips…there are umpteen ways by which you can pump up your sales with some remarkable lean management tactics.

Lean management in creating value for the customer

And, there is another very core aspect of lean management for sales, which will help you pump up your sales with some remarkable lean management tactics. Creating value for the customer is what a business essentially exists for, right? When this is done by applying lean management principles, there is a tremendous boost to the value the customer gets from the company’s products or service. One way of accomplishing this is by integrating sales with the entire processes the company has.

Integrating sales with the other processes ensures that sales becomes part of the operations to the extent that operations are designed and implemented keeping sales in mind and not in isolation of it. Bringing this vital element into the processes rounds up the whole cycle and enhances the value chain on an unimaginable scale.

The direct offshoot of such an integration is that when the customer sees value in the company’s products or services, there are fewer complaints or recalls. This is the finest means of augmenting the company’s resources because the fewer these items, the more it can leverage its resources for further improvement.

In this way, many such activities round sales can be minimized. These count for lean practices, although it must be said that these lean principles have not been designed keeping sales in mind. That however, does not take away from the relevance or value of lean principles to sales.





4 Important CLSI Guidelines According to Assay Validation

They will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly follow.

Each of the assay performance characteristics (specificity, sensitivity, accuracy, precision, linearity, stability, reportable range, reference range) will be explained in terms of experimental design and statistical analysis.

Most assay validations are a compromise between scientific principles, regulatory requirements, and limited resources in reality. They will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly follow.

Though the CLSI guidelines provide much more actionable details than other guidelines (e.g. by FDA, USP), the understanding and adoption of the guidelines remains a challenge for the broad users. Plus, due to reality restraints, oftentimes the study design and/or the statistical analysis suggested by the guideline cannot be exactly followed.

In this webinar, major CLSI EP guidelines will be introduced. The focuses are

(1) interpreting the procedure for each guideline,

(2) intuitive explanation of the statistical methodologies,

(3) using real-life examples to illustrate the use of the guidelines, and

(4) discussing some solutions when facing challenges in implementing the guidelines.


These are the areas covered by the mentor


  • Sensitivity (EP17)
  • Accuracy (EP9)
  • Precision (EP5)
  • Specificity (EP7)
  • Matrix effect (EP14)
  • Statistical Process Control (SPC)

Don’ Miss these Guidelines Going Viral


Using autoantibody [biomarkers] to drive safer and more effective treatments

The game-changing importance of cancer immunotherapies and the coming of age of this approach was further confirmed by the awarding of the 2018 Nobel Prize in Physiology and Medicine.

For a number of years now, immunotherapy has been seen as the dawn of a new era, and is the most promising approach to cancer treatment since the use of targeted therapies, making headlines as results for successive novel immunotherapeutic drugs and combination therapies are released.

These innovative therapeutic strategies, which harness the body’s own immune response to fight cancer, have truly revolutionized the field, giving hope to the millions of individuals diagnosed with cancer every year.The game-changing importance of cancer immunotherapies and the coming of age of this approach was further confirmed by the awarding of the 2018 Nobel Prize in Physiology and Medicine to James Allison and Tasuku Honjo, for their remarkable contributions to the field ofimmuno-oncology.

Given their enormous potential, a broad range of immunotherapeutic strategies, including chimeric antigen receptor T-cell therapies (CAR-T cells), therapeutic vaccines and immune checkpoint inhibitors (CIs) are already on the market and numerous others are under active clinical development. Concerted research efforts have translated into large numbers of clinical trials, with various reports putting the number of ongoing trials at between 800 and 1000in the United States of America alone.Some of these treatments have already gained market approval, with a raft of new immunotherapeutic drugs expected to reach the market in the next couple of years.

This comes amid annual growth in the immuno-oncology sector of around 15% a year, according to Zion Market Research, with the market expected to be worth over 97 billion US dollars by 2022.

Despite this justified optimism, there remain a number of key challenges limiting the future potential of immuno-oncology treatments. While immunotherapies are proving to be highly effective in some groups, it is now clear that many patients do not respond to treatment or suffer from inflammatory side effects known as immune-related adverse events (irAEs). IrAEs can range from non-life-threatening conditions such as skin rash, through to more severe, life-threatening ones involving the endocrine glands, joints, liver, lungs and other organs, resulting in the potential termination of treatment. In some cases, fatal irAEs have been reported. However, as few standardized diagnostic criteria for irAEs currently exist, concerns have been raised that the number of incidences are underestimated.

Such irAEs are most prominent for CIs,owing to their mechanism of action and their widespread use in mono-, put particularly combination therapies.Immune checkpoints act as negative immune regulators of autoreactive Tcells – in essence, acting as ‘brakes’ – that preventautoimmunity. However, once these checkpoints are inhibited and these brakes are removed, the activated T cells can cause an over stimulation of the immune system,resulting not only in beneficial anti-cancer effects but also in an autoimmune response.

Because of these risks, irAEs have been known to put a stop to the clinical development of some immunotherapeutic drugs, they may also limit the progress of immuno-therapies in earlier stage cancer patients. Once severe irAEs are encountered, patients often decide (or are required) to discontinue their clinical trial participation or treatment. In some cases, regulatory bodies such as the US Food and Drug Administration have intervened to halt trials, even when promising results were observed. Clearly, this is a challenge for patients, bio pharmaceutical companies and regulatory authorities, and a solution is highly sought-after.

Consumerization of Healthcare, AI, and the Shifting “Physician-Patient” Relationship

The next important step in enabling patients to inquire about their own personal health.

The classic story of disruptive technology is all too familiar. Travel websites replace agents by giving consumers access to the same rates. Uber offers transportation outside of the established taxi cab system. Amazon brings outlet shopping into our homes. The common thread in all these examples is the transfer of more power to consumers. These changes usually cut costs, increase efficiency and often force out those who cannot keep up. Most of these fundamental developments occur in fields that do not require highly technical expertise, such as housing and transportation, allowing consumers to take control without extensive training.

The specialized knowledge and professional barriers in medical practice have, for many years prevented consumer involvement — leaving control and decision making solely in the hands of the healthcare provider, with the patient largely on the receiving end of information that directly affects their care.

However, these barriers are beginning to crumble.

Over several decades, patients have become more active in pursuing better care and are looking for knowledge sources that can help them become more educated and active participants in their care. Recently, advancements in AI (artificial intelligence), big data analytics, mobile technology and cloud computing have started to enable patients to take greater control of their medical care, leading towards a major shift in the patient-physician relationship.

The first hint of the evolving physician-patient relationship started when medical information became accessible to the layperson. Websites such as WebMD began to make medical literature comprehensible, accessible and searchable. Beyond this, social media and patient blogs allowed people to compare their experiences with others’, creating a better understanding of what their symptoms may be telling them. However, this data was still too general and not personalized.

Patient access to their personal health records (via patient portals) was the next important step in enabling patients to inquire about their own personal health.

Next, mobile technology has allowed patients to track, store and manage their medical history with increasing accuracy. Furthermore, FDA-cleared wearables have advanced to provide vital signs and other sensor-related data, adding more dimensions to the personal clinical data stored on the consumer’s mobile.

Now, consumer-focused companies such as Apple, are providing consumers with access to their full medical records from multiple healthcare providers on their mobile devices. Together with the wearable sensor and patient-entered data, the patient now has access to a far more enriched, comprehensive and accurate up-to-date data than any of the individual healthcare providers treating him/her.

However, understanding the clinical implications of the data to the individual is challenging for most consumers. Consumers are flooded with their own clinical data, with limited ability to utilize this data to benefit their own health.

Very interesting & Huge information never miss this