Shruti Bhat PhD (Pharmaceutics), MBA, Lean Six Sigma Black Belt
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Out of Specification Impurity and Non-Compliance to Manufacturing Standards Continue to Haunt Pharmaceuticals- The Lupin Story.  Here's One Way to Correct the Mess ...

1/29/2019

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out of specification impurity and non-compliance to manufacturing standrds continue to haunt pharmaceuticals- the lupin story. Way to correct the mess by dr shruti bhat, continuous improvement tools, kaizen
Out of specification impurity continues to haunt pharmaceutical products. There is yet another USFDA report citing out of specification product impurity and inappropriate processing issues in a reputed pharma company!

For the third time in four months, Lupin Pharmaceuticals has been admonished by the Food and Drug Administration for a series of troubling quality-control issues at a manufacturing facility.

In a recent inspection report dated January 25, 2019, the regulator cited the company for failing to thoroughly review unexplained deficiencies in batches of medicines and not taking ‘scientifically sound’ steps to evaluate samples.

Few other deficiencies include- OOS (out of specification) investigations not handled correctly, impurity levels in products exceed specification limits and detailed health hazard assessment for the presence of this impurity was not conducted as needed.

Further remarks include- failure to re-train analysts who were involved in the purported mis-identification of product impurity, CAPA (Corrective Actions Preventive Actions) not designed and implemented correctly, insufficient investigation of customer complaints.
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Other observations include- Appropriate controls were not exercised over computers or related systems to assure that changes in master production and control records or other records are instructed only by authorized personnel; Equipment used in the manufacturing, processing, packaging or holding of drug products is not of appropriate design to facilitate operations for its intended use; Established lab control mechanisms are not documented at the time of performance, and a lack of oversight and training.


Related reading:
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  1. Valsartan, Irbesartan, Losartan Product Recalls- What are the Lessons for Pharmaceutical Industry?
  2. Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
  3. Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke​​​
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​A detailed root cause analysis shall of course open avenues of true ‘problem areas i.e. disjointed business processes’ which need correction, followed by a neat process improvement strategy and its flawless execution.​

Ideally, pharma companies must structure a dedicated Continuous Improvement lead and team within its organogram.

​There are over eighteen different continuous improvement methodologies to choose from.

Kaizen can be an excellent start to sort out this mess.​
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How to Employ Kaizen in Pharmaceutical Operations?

Though a combination of nine types of Kaizen would be most suited; for starters, Gemba Kaizen can provide maximum help.

Gemba Kaizen is a method of continuous improvement that involves real time action. It is commonly used to add valuable activities to an organization, which help to add to the quality of customer satisfaction. When a problem arises, Gemba Kaizen pinpoints the issue as promptly as possible. The solution to the problem is then used to deal with the same problem, if it should reoccur, but ideally stops the problem from reoccurring in the first place. 
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This method also implements ideas used in lean manufacturing, which help to reduce waste and unnecessary procedures.

One of the main goals of Gemba Kaizen is to eliminate anything that is not valuable, or adds value, to an organization, whether it is systems, procedures, employees, business verticals, machinery, facility and others. 
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Workshop & Online Course on Kaizen:
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​Kaizen Case Studies:

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  1. Reduced Variations in Eye Drop Dosage; a Continuous Improvement Case Study: Kaizen in Pharmaceutical Product Development
  2. Kaizen Improved Patenting and Patent Filing Process ~ 20% drop in Patenting Cost; a Continuous Improvement Case Study
  3. How to Speed-up Pharmaceutical Generic Product Development?: Continuous Improvement Case Study

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Continuous Improvement in Cancer Therapy & Healthcare System Services

1/23/2019

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Today I read a report in Stat News about the first ‘digital pill’ that has been rolled out at a Cancer Treatment center in Minnesota US. The report mentions how chemotherapy pills taken by cancer patients are packaged with a sensor that can alert a physician, pharmacist, or caregiver after the pill has been swallowed.

The report highlights that seven patients — all of whom have colorectal cancer in stage 3 or stage 4 and are being treated in Minnesota — have been provided with this treatment. The idea is that, by tracking when patients take their drugs, health care providers will be better able to ensure medication adherence and to provide treatment guidance, with the goal of improving health outcomes.

How does digital pill work?:

After patients swallow a chemo capsule, the sensor gets activated once capsule gets damp in the stomach fluids. The sensor then pings a signal to a patch worn by patients on their torso; which transmits data on the time of day, the size of the dose, and the type of medication taken to an online portal that the patient can view. If patients choose to allow it, their support team can access this database portal too.

This program in Minnesota appears to be the first one in which a digital pill has been used in oncology. So far, neither patients nor insurers pay anything beyond the typical cost of the medication for this high-tech upgrade.

This news sparked my interest for several reasons-

  1. As there is high proliferation of cancer disease world-wide, such digitization of cancer therapy will hopefully bring benefits to a wider population of cancer patients.
  2. Despite advances in Oncology, not everything about cancer is understood by researchers, doctors, patients and care givers. The resulting effect is that there is no cure for cancer, especially once cancer has metastasized or is beyond stage 2. Another peculiarity of cancer is that no two types of cancer are same, hence medications and their dosages administered to cancer patients are different. For example, dosage of Tarceva tablets prescribed for a lung cancer patient is different from what is prescribed for a patient with pancreatic cancer. However, the digitization platform done for chemotherapy of colo-rectal cancer can be researched further to extend to other cancer types, which can yield better patient compliance, superior therapeutic modeling and better treatment outcomes to a wider patient population.
  3. Additionally, this concept of  'digital pill' can be extended to other disease types too, where patient compliance has always been a problem; for example Tuberculosis, Schizophrenia, hypertension etc. Drug-resistant tuberculosis is worse to treat than regular TB. Hence, a digital TB pill will be  a boon for patients and doctors alike. Similarly, patients forgetting to take their blood pressure pill is usual, especially among older folks. Such non-compliance issues can hopefully be nipped in the bud with digital pharmaceuticals for hypertension.  
  4. Such digital pills can substitute the health system services which invest in phone calls and other reminders to patients to help them stay on track with their medications.

'Digital' pill is not only an impressive step in Continuous Improvement for Cancer Therapy, it is a significant step in Continuous Improvement for Health System services too! and, hopefully pave way for Continual Improvement in TB care, hypertension management and patient-centric drug product design.


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Learn to ready yourself for USFDA and other regulatory audits, workshops by Dr Shruti Bhat

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Reduced Variations in Eye Drop Dosage; a Continuous Improvement Case Study: Kaizen in Pharmaceutical Product Development

1/16/2019

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Learn how Kaizen was used in Pharmaceutical Research and Product Development to reduce variations in product administration ...

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Workshops & Online Courses for Pharmaceutical Research and Drug Product Development by Dr. Shruti Bhat

10/23/2018

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About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

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USFDA Unveils Two Draft Guidance Documents to Facilitate Generic Development of Transdermal and Topical Dosage Forms

10/9/2018

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revised fda guidelines for transdermal patch and topical products
revised usfda guidelines for transdermal and topical products
The United States Food and Drug Administration (USFDA) today 9th October 2018, unveiled one revised draft guidance and another new draft guidance to help advance the development of generic Transdermal/Topical Delivery Systems (TDS). Here's a snapshot:

When applied to a patient’s skin, Transdermal/ Topical products are expected to deliver the correct dose of the medication consistently and for the expected length of time, while adhering consistently and uniformly to the skin, even when the skin is exposed to water, humid environment and/or body movement.

Because of the inherent complexity of delivering a drug through a transdermal/ topical system, making generic copies of these branded (reference listed) transdermal/ topical drug products is hard; and the two draft guidance documents aim to mitigate this problem.

ANDA Guidance document for assessing Irritation and Sensitization:

This 12-page guidance provides recommendations for Abbreviated New Drug Application (ANDA) sponsors on the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system.

Applicants must perform a comparative assessment of the generic and reference listed transdermal/topical drug products using an appropriately designed skin I/S study with human subjects. The draft document demonstrates that the potential for a skin irritation or sensitization reaction with the Test-TDS is no worse than the reaction observed with the Reference-TDS.

Study design and conduct, considerations for statistical analysis, overall assessment of adverse event data and format of data submissions are outlined in the draft guidance. (Note: The recommendations relating to the design and conduct of I/S studies described in this guidance replace the recommendations related to I/S studies provided in product-specific guidances published before this guidance. This set the stage for revisions in bioequivalence (BE) study guidelines for 23 TDS products).

ANDA Guidance document for Assessing Adhesion

This revised 9-page draft guidance supersedes a draft from June 2016 and provides recommendations for the design and conduct of studies evaluating the adhesive performance of a TDS.

Apropos the guidance document, depending on the objective(s) of a transdermal/ topical dosage form product development program, applicants may choose to evaluate transdermal /topical adhesion in clinical studies performed to evaluate adhesion only or in clinical studies performed with a combined purpose (example- for simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints).

Additional topics covered in the revised draft include the study design and conduct, considerations for statistical analysis, as well as recommendations on the combined evaluation of adhesion and bioequivalence.
About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

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References:
  1. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry
  2. Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry


​Learn more about how to error-proof product development-

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Lean Manufacturing in Food, Drug, Cosmetics & Chemical Industry

10/9/2018

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Learn about how to use LEAN Business Process Improvement methodology for Innovation and Manufacturing …

Case Study: Improved productivity of pellet manufacturing by 28% per shift via LEAN

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Popular Books on Business Process Improvement:
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To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

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Advances in pharmaceutical research- use of nanotechnology as therapeutic platforms for disease management.

8/15/2017

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Dr. Shruti Bhat, Pharmaceutical Industry Thought Leader, brings to you some highlights from current pharma and clinical research news, views and data.
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Picture
New nanoparticles deliver bigger drug payload.
Scientists at Brigham and Women's Hospital and the Harvard-MIT Division of Health Sciences and Technology have developed new nanoparticles from a modified polymer that can more efficiently load up on cancer drugs and deliver them more precisely.

These new nanoparticles inhibit the MARK signaling pathway, which helps prevent the spread of cancer cells and makes tumors more susceptible to chemotherapy.

"Current chemotherapy drugs must be administered in high concentration throughout the body in order to destroy tumor cells, translating to high toxicity and discomfort for the patient, mainly due to the effects on normal cells," co-lead author Rania Harfouche said in a release. By modifying the polymer, researchers "allow for lower drug concentrations to be used, and provide opportunity for more potent treatments with lesser side-effects for the patient."

In a study involving mice, the nanoparticles inhibited tumor growth. And the scientists say that this new approach to cancer therapy could have wide applicability. ​
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​Scientist creates 'nanocage' drug delivery system.
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Washington University's Younan Xia has been attracting considerable attention for his research work on microcapsules that can precisely deliver a drug payload right where it's needed.
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​Xia has been making microscopic gold 'nanocages,' tiny particles encased in polymer strands that collapse when exposed to heat. "But the really cool part," says Xia, "and the cool part of nanotechnology generally, is that the tiny gold cages have very different properties than bulk gold." In particular, they respond differently to light.

Using a near infrared light, the scientist can trigger a collapse at any point, leaving the tissue unharmed. Adjusting the light can recalibrate the release rate. And by designing the polymers to latch onto specific disease targets, such as a tumor, Xia believes he can concentrate the drug right where it's needed. ​
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​Nanoparticles used to deliver targeted ED drugs.
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Nanoparticles "smaller than a grain of pollen" have been engineered to carry minute quantities of therapeutics for erectile dysfunction, effectively delivering the drug directly through the skin in animal models. And the team of researchers at Albert Einstein College of Medicine at Yeshiva 
 University says that the same approach could be a better alternative to existing drugs while safely working in men who currently are prohibited from taking the tablet meds.
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​Scientists used rats bred to suffer from erectile dysfunction to test the nanoparticles. "The response time to the nanoparticles was very short, just a few minutes, which is basically what people want in an erectile dysfunction medication," says Dr. Kelvin Davies. "In both rats and humans, it can take 30 minutes to one hour for oral erectile dysfunction medications to take effect."

The oral drugs are associated with a number of side effects, including blurred vision and upset stomachs. Men who have suffered a heart attack, meanwhile, are prevented from getting the ED drugs at all. But the researchers say that a locally applied topical solution was effective without side effects in rodents. ED drugs have been prominent best-sellers and an improved approach could also prove to be highly profitable.
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Nanoparticles boost antibacterial treatments.
The University of Liverpool and IOTA NanoSolutions have developed man-made nanoparticles that could increase the effectiveness of antibacterial treatments. Many current drugs are insoluble and need to be administered at higher doses in order to work. However, this increases the chances that bacteria and other organisms will build up a resistance to the drugs. In time, new formulations of medicines must be developed in order to knock out the mutated organisms.
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University of Liverpool researchers found that in some instances, the nanoparticles can be used to make insoluble drugs behave like soluble drugs, increasing their effectiveness at lower doses. Scientists are concentrating on applying the nanoparticle technology to antiparasitic drugs that treat malaria.

"Already our technology has shown the potential to improve a range of current medicines and may lead to treatments that prevent drug resistance," said Professor Steve Rannard, from the Department of Chemistry, who is also co-founder and current Chief Scientific Officer of IOTA NanoSolutions. "If our approach can deliver new antimalarial treatments, it may help to prevent millions of deaths per year and improve the lives of hundreds of millions of current malaria sufferers."
Nanoparticles research aids drug development.
Drugs with the ability to dissolve have much stronger efficacy, however many drugs are insoluble. In order to compensate, drugs often need to be administered in higher doses. This increases the possibility of bacteria and other organisms mutating as the high doses make it easier for them to build resistance to the drugs. This leads to treatments becoming obsolete and the need for new medicines to be developed.

Chemists at the University of Liverpool working with IOTA NanoSolutions have now developed a new technology to produce nanoparticles of insoluble drugs that mimic the behaviour and the effectiveness of dissolved drugs.

Nanoparticles are man-made particles manufactured for use in a number of industries including the cosmetic and pharmaceutical industry; they can make materials stronger, lighter and cleaner.

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​Recent data has shown that in some cases, low concentrations of insoluble drugs in a nanoparticle form can be more active than previously thought, offering the potential to administer drugs in low dosages without reducing the effectiveness of the treatment. The new technology is allowing the scientists to develop new medicines by converting currently available drugs into a nanoparticle form. Antiparastitic drugs to treat malaria are also being developed in collaboration with the Liverpool School of Tropical Medicine.

Professor Steve Rannard, from the Department of Chemistry who is also co-founder and current Chief Scientific Officer of IOTA NanoSolutions, said: "Already our technology has shown the potential to improve a range of current medicines and may lead to treatments that prevent drug resistance. If our approach can deliver new antimalarial treatments, it may help to prevent millions of deaths per year and improve the lives of hundreds of millions of current malaria sufferers."

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Nanoparticle program delivers anti-cancer therapy.
A research team at Washington University in St. Louis has combined a nanoparticle platform used in imaging growing blood vessels and combined it with the fungal drug fumagillin to create a new weapon to fight the growth of tumors. Fumagillin has long been known as a potent anti-cancer therapy, but its neurotoxic side effects are too harsh for patients. To circumvent the side effects, the scientists adapted nanoparticles designed to dock on a protein carpeted on endothelial cells clustered on the walls of new blood vessels and loaded them with fumagillin. By targeting the therapy directly at the new blood vessels, the therapy can stop angiogenesis, a key target in oncology research.

"It basically becomes a vehicle to dump off a truckload of cargo," Joseph DeSimone of the University of North Carolina tells MIT Technology Review. "It's sort of like a Trojan horse."

There are a number of research programs underway relying on animal studies to determine the effect of new nanoparticle technologies that can interrupt angiogenesis. First-generation nanoparticle therapies rely on passive delivery methods while this second generation round of research is working on new technology aimed at more precise targeting of disease.


Nanomaterials used to fix neuron damage.
Northwestern University researcher Samuel Stupp has presented the results of a study in which he injected nanomaterials into the severed spinal cords of mice, allowing them to walk again after several weeks of therapy. The nanomaterials he used were designed to self-assemble into nanofibers which repaired damaged neurons. The research offers new insights into the near-term research potential of nanotechnology and offers hope for patients with Alzheimer's and Parkinson's who suffer from severe neuron damage.

"Regenerating bone and cartilage are our first targets," Stupp told the Chicago Tribune. "That would be very important to Baby Boomers who value their quality of life. We are also working with regenerating blood vessels to address damage from heart attacks. (Nanotechnology) will first aid in diagnosing illness, but it also will provide therapies to alleviate or cure." 
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Nanoparticles offer ovarian cancer treatment approach.
Magnetic nanoparticles have been used to ‘drag' cancer cells out of the bodies of mice. Scientists at Georgia Tech coated the nanoparticles with a targeting molecule that caused them to bond to the cancer cells. And the researchers say the approach could be used to treat metastatic ovarian cancer. During metastasis, the cancer cells drift in the abdominal area, offering a target for the nanoparticles. They believe that a patient's abdominal fluid could be drained, cancer cells filtered out, and then infused back into the abdominal cavity.

"It's possible that the particles may not ever have to go into the patient's body," says John McDonald, the chief scientific officer of the Ovarian Cancer Institute at Georgia Tech. "That would be preferable, because then you don't have to worry about any potential toxicity."


About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
 
#ShrutiBhat  #ContinuousImprovementAcademy  #Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #Innoworks  #Innovation  #Quality  #eLearning  #Business  #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeScience  #Food  #Beverage  #Biotechnology  #Retail  #Cosmetics  #PersonalProducts  #Chemicals  #Drugs #Engineering #ShiftingParadigms #BPM  #LeanManagement  #KaizenLeaderMasterclass  #LeanSixSigma  #Kanban  #FMEA  #RiskManagement


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References-

Rea
d more: http://www.fiercebiotechresearch.com/story/new-nanoparticles-deliver-bigger-drug-payload/2009-04-28#ixzz0kS4utcYO
http://www.sciencedaily.com/releases/2009/11/091101132539.htm
Read more: http://www.fiercebiotechresearch.com/story/nanoparticles-used-deliver-targeted-ed-drugs/2009-09-22#ixzz0kS5TN3ev
Read more: http://www.fiercebiotechresearch.com/story/nanoparticles-could-boost-antibacterial-treatments/2008-11-10#ixzz0kS5umDfi
Read more: http://www.fiercebiotechresearch.com/story/nanomaterials-used-to-fix-neuron-damage/2007-05-01#ixzz0kS6W39Pt
Read more: http://www.fiercebiotechresearch.com/story/nanoparticles-offer-new-approach-treating-ovarian-cancer/2008-07-22#ixzz0kS6iAbJA
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