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Quality Management Systems guide organizations in manufacturing and services toward consistent quality and customer satisfaction. Through structured and standardized processes, continual improvement, and focused customer feedback, quality management systems help organizations to enhance performance, reduce errors, and ensure a commitment to excellence, fostering trust and reliability in their offerings.
Here you will find articles on various techniques of improving quality, quality management systems, quality risk management, tools to identify and solve quality problems, how to bring about a culture of quality at your organization, cost of quality, mistake proofing processes, quality-by-design, quality improvement case studies etc. |
Popular Articles on Quality Improvement:
Operational Excellence in Chemical Industry: Proactive Safety and Crisis ManagementThe recent report of gas leak at a chemical factory in Thane, India, resulting in residents complain of eye irritation and breathing difficulties, serves as a critical reminder of the importance of operational excellence in ensuring safety and crisis management. Read More
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How Kaizen Boosted Stability, Compliance and Reduced Batch Deviations in Pharma ManufacturingIs batch variability affecting your pharma compliance? Checkout how Kaizen transformed chaos into compliance and consistency, driving down batch deviations by 40% in pharma manufacturing. Read More
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How to Manage Inventories, Cut Wastages and Rejects in Warehouses? A Lean Six Sigma Case StudyA Canadian Drug company had huge inventory and also wastages in their warehouse. Read More
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How to Reduce Testing Load of Analytical Labs in R&Ds? A Six Sigma Case Study in a Biotech CompanyCanadian Biotech company had too many samples for testing in their research lab. How to cut down this analysis load? Read More
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Revisit your KAIZEN strategies as FDA unleashes 69 product-specific guidances.USFDA published a new batch of sixty-nine product-specific guidances (PSGs) Read More
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How Can Pharma and Biotech Companies Maintain Quality While Rapidly Scaling Up OperationsOne of the biggest challenges facing pharma and biotech companies is scaling-up production and maintaining high quality standards. Read More
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What is meant by the term cost of quality? How to reduce cost of quality?Cost of Quality refers to the entire sum that takes to produce a product or service while guaranteeing high standards of quality. Read More
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Root Cause Analysis- a vital tool for curing quality problemsRoot cause analysis makes it easier to identify the reason a problem occurred in order to prevent it from reoccurring. Read More
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7 Important tools to identify a "Quality" problem.These problem-identification tools are the most commonly used and most effective tools for both- identification of the quality problem as well as ideating for potential solutions to solve / circumvent the problem. Read More
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Use Strategic QbD to improve Business ResilienceThe word quality-by-design was introduced by Juran in his work on quality management. And since then organizations have used QbD to introduce quality aspect into products and services. Read More
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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 ...Out of specification impurity continues to haunt pharmaceutical products. There is yet another USFDA report citing out of specification product impurity Read More
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Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?Even though Impurities in drugs and drug products are a part of manufacturing process, drug companies strive hard to keep them at minimal and within specifications; be it Read More
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Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka YokeUsually a defect is construed as a product defect. Pharmaceutical cGMP norms and other FDA regulations bring check to product defects from happening, as well as in most cases, check defective products reaching the patients. Read More
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Quality Systems Approach to Pharmaceutical CGMP- Quality-by-Design (QbD).Definitions and scope of quality systems in pharmaceuticals has evolved over a period of time. The “Thalidomide babies tragedy” prompted the concept of continuous or cGMP. With cGMP came into existence the concept of Quality Assurance or “Zero defect”. Read More
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Transitioning from Computer Software Validation (CSV) to Computer Software Assurance (CSA)Transition strategy; it must include a focus on data integrity, product safety, and patient safety. Read More
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Benefits Of Modernizing Life Sciences Regulatory Information ManagementPlanning to invest in updating your company’s regulatory information system and workflows? Read More
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How to Overcome Challenges in Life Sciences Regulatory Information ManagementThe Life Sciences industry is highly regulated, requiring companies to maintain a high level of compliance and information management. Read More
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What are the drawbacks if Regulatory Information Management (RIM) of life sciences organizations is not modernized?As the cost of developing and bringing new drugs to market continues to rise, regulatory bodies' requirements become more Read More
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Economic Impact of Life Sciences Regulatory Information ManagementThe life sciences industry is facing numerous challenges, including escalating costs of research and development, increased competition in new markets Read More
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USFDA Guidance on Life Sciences Regulatory Information ManagementThe USFDA recently released guidance to improve life sciences regulatory information management. The guidance aims to improve data input into the quality system Read More
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Challenges in Modernizing Life Sciences Regulatory Information Management SystemsThere are many challenges to modernizing life sciences regulatory information management (RIM) systems. Read More
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Kaizen For Quality Improvement Of A Pharmaceutical Product - A Case StudyKaizen was implemented to reduce variations in ophthalmic product administration. Read More
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Role of Statistical Quality Control (SQC) in Business Transformation and Continuous Improvement.The tools used in statistical quality control are beneficial for examining service or product quality. Read More
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Six Sigma in a NutshellWhen a business problem is selected to become a potential Six Sigma project, it goes through a critical metamorphosis Read More
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What is the biggest challenge to applying Six Sigma in the Service industry? Does Six Sigma compulsorily demand achieving 3.6 million or lesser defects per million opportunities (dpmo)?One of the biggest challenges to applying Six Sigma in a service industry is high number of variations Read More
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Why should you modernize regulatory information management in life sciences organizations?Regulatory information management (RIM) is an important part of the quality compliance management process for life sciences companies. Read More
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80% Reduction in Product Returns; a Continuous Improvement Case Study: Kaizen-based improvement in Manufacturing and Service ProcessesLearn how Kaizen was used to improve manufacturing and service processes Read More
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Valsartan, Irbesartan, Losartan Product Recalls- What are the Lessons for Pharmaceutical Industry?Presence of a potential carcinogen impurity in the drug as well as drug product clearly shows flaws in 'development and manufacturing processes'. Read More
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CAPA- a vital business management toolCAPA, otherwise known as Corrective Actions Preventive Actions, is a vital key to a management system of high quality. Read More
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4 Vital steps of effective business process benchmarking.Process benchmarking refers to a strategic tool used to compare one’s business against another’s in order to find out what practices are obsolete and which should be used instead. Read More
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4 Key Features of Manufacturing Process Qualification.Manufacturing process qualification is necessary to guarantee that a particular process is working in a consistent manner in order to create a product Read More
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3 Stages of Manufacturing Process Qualification.Manufacturing process qualification can be explained as collecting and evaluating data from the beginning stages to final production in order to find out how a product Read More
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6 Reasons for Conducting Business Process Qualification.Business process qualifications can give you a new career path in which it is your job to assess and evaluate the various procedures and processes used in an organization. Read More
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What is Business Process Qualification ?Business process is used to define the acquirement of details relating to various activities that end up improving a product or service. Read More
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Limitations of TQM methodologyTotal Quality Management, or TQM, is a series of techniques that is meant to deliver the high quality products or services to the customer. Read More
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What are the advantages of TQM methodology ?TQM uses a combination of problem-solving methods and evaluation in order to determine and get rid of flaws in an organization. Read More
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What is TQM- Total Quality Management?Total Quality Management, or TQM, is a technique that aims to enhance performance and quality that lives up to the expectations of the customer. Read More
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TQM in a NutshellTQM (Total Quality Management) actively preceded LEAN and much of its focus on waste-reduction, continuous improvement and elimination of defects Read More
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Are you choosing your doctor correctly? How do you choose your medicines? YOU decide quality of your life- Part 1 of 2News articles dropping in my email inbox, about allegedly corrupt medical practices affecting patient’s health and finances Read More
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Are you choosing your doctor correctly? How do you choose your medicines? Tips - Part 2 of 2In order to take an informed decision, one needs to obtain background information about your potential doctor, clinic, Read More
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How to dispose expired medicines?Expired or time-barred medicines are medications that have passed on their expiry date (stated on its label). Read More
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Is your medicine cabinet stuffed with expired or medications you no longer use? Check out this post ...The following guidelines were developed to encourage the proper disposal of medicines and help reduce harm from accidental exposure Read More
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Can cytotoxic substances and high potency actives- api be manufacture in the same manufacturing facility on campaign basis? What's the regulatory angle?It is important to distinguish a drug with a characteristic that poses a high occupational risk from its characteristic therapeutic Read More
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Streamlined Process Improvement - A shortcut technique for improving business efficiency and profit.It is normal for organizations to find themselves in a rut since many processes become ingrained due to repetition. An easy solution is Streamlined process improvement. Read More
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Continuous Improvement using SWOT analysis.Ideally, SWOT analysis should be used at the earliest stages of decision making for improving strategies or a continuous improvement program. Read More
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Quality Control & Regulatory Requirements of Controlled Release Drug Delivery SystemsIn order to gain FDA approval of New Drug Application for a new chemical entity initially marketed in Controlled Release Dosage forms Read More
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What is ISO Approach for Business Process Improvement and Quality Management ?The process approach to ISO permits the standard of Quality Management Systems. It can be used for all sizes of organizations Read More
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How to solve issues like improving team members performance who are not meeting quality standardsTeam development and performance is a critical aspect of improving operational excellence Read More
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Differences between ISO Vs CMMI and ISO Vs Six SigmaOften, CMMI is compared to ISO 9001, and rightly so since they are similar in terms of improving quality systems Read More
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Evaluation of pellets prepared using factorial experimental designs.The pellets were evaluated and characterized for various physical measurements Read More
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Advances in anti-counterfeiting technologies for packaged productsReports have been rising consistently about seizure of counterfeit packaged products- more so for pharmaceuticals and cosmetic products. Read More
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Syrup Medicines Banned in Indonesia! Isn’t there a way to formulate safe syrup products?The health ministry of Indonesia has temporarily banned the sale of all syrup and liquid medicines, citing the risks to children Read More
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Gambia cough syrup tragedy: How can we stop such catastrophe?Dozens of child deaths have been reported recently in African country The Gambia. The deaths are allegedly linked to cough syrups containing unacceptable levels of diethylene glycol Read More
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What is the difference between ISO and Kaizen continual improvement techniques?ISO and Kaizen are both time-tested continual improvement techniques. Both ISO and Kaizen can be used for continuous as well as Read More
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Analytical considerations of mucosal drug delivery systemsClassical chemical substances, drug and diagnostic products that have their origin in biotechnology must meet standards Read More
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Study: Generic nifedipine product not bioequivalent to Adalat XLBased on the study results from in vitro and in vivo tests, the generic extended release nifedipine product has a delayed Read More
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USFDA Unveils Two Draft Guidance Documents to Facilitate Generic Development of Transdermal and Topical Dosage FormsWhen applied to a patient’s skin, Transdermal/ Topical products are expected to deliver the correct dose of Read More
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Workplace incivility on the rise, what can we do to stop it?There is a disturbing trend in Corporate North America. Despite increased talk about improving corporate culture, there is a civility problem in the workplace. Read More
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Microbial contamination in lake and dye colors- Part 3 of 3The isolation was done by transferring the colonies from nutrient agar plated to sterile enrichment broth media. Read More
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Microbial contamination in dye and lake colors- Part 2 of 2Marketed samples of Indigo carmine, Sunset yellow, Erythrosine and Ponceau 4R dye and their aluminum lakes. Read More
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Microbial contamination in dye and lake colors - Part 1 of 2With the advent of out-sourcing of pharmaceutical products especially by Americas and the western world, pharma products have to Read More
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What are substantial and effective changes in ISO 9001:2015 and how will it impact our organization?The ISO 9001:2015 features two important changes, both in content and structure. Read More
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FDA Adds QR Code to Certain Export Certificates for Food.USFDA announced addition of QR Code to certain export certificates for food products. This unique QR code will allow easier verification of the authenticity of the export certificates. Read More
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Are there any points to watch out before selecting ISO methodology for a company?The ISO approach is vital for businesses and organizations to strive and develop a good reputation, as well as, to excel in future aspirations of the company. Read More
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What are the Limitations of ISO approach in Business Process Improvement and Quality Management?The ISO approach is vital for businesses and organizations to strive and develop a good reputation, as well as to excel in future aspects of the company. Read More
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What are the Advantages of ISO Approach in Business Process Improvement and Quality ManagementA company’s main goal should be to provide quality. This can often be hindered by in-competence, productivity and other factors that get in the way, such as Read More
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Quantitative Estimation : HPTLC Vs HPLC pros and cons - Part 4 of 4Under the chromatographic conditions described, the migration distance obtained in the case of both the reference as well as the test samples of pseudoephedrine hydrochloride Read More
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Quantitative Estimation: HPTLC Vs HPLC pros and cons- Part 3 of 4The selectivity of the method was checked by spotting 50μg x μl –1 of pseudoephedrine HCl (a structurally related drug) individually Read More
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Quantitative Estimation : HPLTC Vs HPLC pros and cons - Part 2 of 4Camag HPTLC system comprising of Camag IV sample applicator Linomat, Hamilton syringe 100 micro liter, Read More
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Quantitative Estimation : HPTLC vs HPLC pros and cons -Part 1 of 4Analysis is a critical and integral part of the pharma business. Its only up on clearance of products on analysis can the products be even released into the market. Read More
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Protracted disintegration of soft gelatin hematinic capsules Part 5 of 5Gelatin- Mineral interaction Read More
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Protracted disintegration of soft gelatin hematinic capsules Part 4 of 5Preparation of gelatin solutions- A typical composition employed was as follows Read More
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Protracted disintegration of soft gelatin hematinic capsules Part 3 of 5When freshly prepared, all the capsules ruptured within 10 mins and disintegrated/ dissolved completely within 30 mins. Read More
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Protracted disintegration of soft gelatin hematinic capsules Part 2 of 5The IEP of gelatin was determined using 30 g of 1 % w/w gelatin solution (prepared in demineralized water) and measuring Read More
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Protracted disintegration of soft gelatin hematinic capsules Part 1 of 5The behavior of aged soft gelatin based hematinic capsules may be attributed to gelatin- mineral and gelatin – vitamin interactions reflected subsequently in the non-compliance Read More
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FDA Approves First-Ever Human Test Of Embryonic Stem Cell-Based TherapyThe USFDA has approved "the world's first authorized test in people of a therapy derived from human embryonic stem cells. Read More
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Developing ANDA Para II and III Drug Products via QbD (Quality by Design) : Case StudyA multi-national bio-pharma company wanted to develop Three new products via QbD methodology for US (ANDA para II and III) Read More
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2 New rules agreed for Medical devices and In vitro diagnostic medical devices in European Union.On 25 May 2016, the EU agreed new rules on medical devices and in vitro diagnostic medical devices. Read More
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