“Audit is a systematic, independent, and documented assessment to determine whether agreed upon requirements are being met and will continue to be met”. In the present article we shall be able to understand the Basics of audits and Key Roles of participants while performing/facing an audit. Audits are considered an integral part of an organization […]
In continuation to our previous article entitled “Friability testing of tablets“, we are hereby providing you the guidelines on Friability testing of granules and spheroids. British Pharmacopoeia and European Pharmacopoeia provides the method in detail. There are basically two methods for determination of the friability of granules and spheroids, which may be used during […]
April 21, 2021 Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Government of India has introduced a new draft General Chapter on ‘Approach to Alternative Rapid Microbiological Method’. The proposed methods would enable faster laboratory testing of the drug(s) like Remdesivir injection, thereby making them accessible to the patients at the earliest without […]
The tablets manufactured by a firm needs to be sufficiently hard to bear the shocks experienced during their packing and transit. Measuring tablet hardness does not reliably indicates the tablet strength as too hard tablets also experience capping or lose their crown portions on attrition leading to chipping or fragmentation. Hence, friability testing of tablets […]
World Health Organization (WHO) in March, 2021 has come up with revised stability conditions for WHO Member States. The list is prepared on the basis of information obtained from following sources: Respective regional harmonization groups (e.g. ASEAN, ICH and GCC). From official communications from national medicines regulatory authorities to WHO. Information collated during the 13th […]
Against the backdrop of globalization, especially in case of pharmaceutical industry, data integrity has become one of the basic expectations that a regulator expects from a manufacturer. USFDA, MHRA, WHO or any other regulatory agency when inspecting an offshore manufacturing premises expects that the data presented to them shall be reliable and trustworthy. The data […]
Apr 02, 2021 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has come up with a national portal for filing of applications for licenses/ certificates for manufacturing, marketing and sales for Drugs and Cosmetics. This was the need of the hour to bring uniformity, traceability and accountability in evaluation […]
India is a country which has a drug regulatory system operating at the Central Level as well as the State Level. At Central level, Central Drugs Standards Control Organization (CDSCO) is the organization which has been given the prime responsibility of approval of New Drugs, Clinical Trials in the country, laying down the standards for […]
Indian Pharma Sector often boasts about being known as Pharmacy of the World. There is no doubt that Indian pharma sector has grown by leaps and bounds. In the rush of achieving more and more it has been observed that somewhere the regulatory aspects w.r.t. safety, efficacy and quality of drugs being manufactured are compromised. […]
As per regulatory requirements, each API, inactive ingredient, finished good, packing material and other related material shall be tested as per the specifications before use and prior to their release in the market for commercial use. But is it required to continue to perform all the tests before use on the material procured from the […]
Parametric release is defined as the system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric Release. All medicines must comply with the requirements stated in the specifications. Does it mean […]
The whole pharma world goes berserk in meeting the ‘product specifications’ as required by various regulatory authorities. Pharmacopeial specifications, In-house specifications, product specific specifications are various types of specifications that are required to be met by a product before release in the market. In pharmacopeial specifications also, every country and it’s regulator relies on different […]
As a part of regulatory requirements, we prepare numerous documents. Preparing documents shall not be treated as a burden but shall be considered as an activity of creating proofs or evidences that shows one’s true self. There are many types of documents such as policy documents, standard operating procedures, standard testing procedures, specifications etc. But […]
Pharmaceuticals in general not only produce drugs but they also produce tons of data. Regulatory agencies across the globe insist on generation of data for each and every activity. We should understand that there is value in data generation. Data is generated automatically when we follow GMP regulations. Significant amount of data is generated when […]
Pharmaceutical products are manufactured with an objective of meeting their predefined objectives of quality, safety and efficacy. However, how hard we try, still there is a possibility of physical product defects that may occur during the entire process of manufacturing at various stages. As a responsible pharmaceutical manufacturer and as per requirement of GMP, every […]
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The defects are observed in the all types of formulations viz. tablets, capsules, injectables etc. To effectively observe the defects there are many requirements w.r.t. trained and qualified operators, Inspection belt, lighting, background etc. In this […]
Oct, 24 2020 Gilead Lifesciences Inc.’s Veklury (Remdesivir) has become the first treatment for COVID-19 to receive the U.S. Food and Drug Administration approval. The drug is approved for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring […]
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The defects are observed in the all types of formulations viz. tablets, capsules, injectables etc. To effectively observe the defects there are many requirements w.r.t. trained and qualified operators, Inspection belt, lighting, background etc. In this […]
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The defects are observed in the all types of formulations viz. tablets, capsules, injectables etc. To effectively observe the defects there are many requirements w.r.t. trained and qualified operators, Inspection belt, lighting, background etc. In this […]
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The defects are observed in the all types of formulations viz. tablets, capsules, injectables etc. To effectively observe the defects there are many requirements w.r.t. trained and qualified operators, Inspection belt, lighting, background etc. In this […]
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The defects are observed in the all types of formulations viz. tablets, capsules, injectables etc. To effectively observe the defects there are many requirements w.r.t. trained and qualified operators, Inspection belt, lighting, background etc. In this […]
The management and disposal of the waste produced in a pharmaceutical manufacturing firm has always been a matter of concern. The waste includes but not limited to in-process wastes, expired products, returned material, manufacturing spillages etc. There has been a lot of hue and cry regarding effective management and disposal of pharma waste as it […]
The objective of any pharmaceutical manufacturing firm is to manufacture a product which fulfils all the requirements of being a product of quality and is also safe and efficacious. The quality of material shall be maintained not only during the production but also during the distribution and subsequent storage. Accordingly, Good Distribution Practices are always […]
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such an approach is to get the maximum output by making use of less time, less effort and fewer resources, that is, to create a Lean process. Continual improvement is an important part of every operation […]
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such an approach is to get the maximum output by making use of less time, less effort and fewer resources, that is, to create a Lean process. Continual improvement is an important part of every operation […]
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such an approach is to get the maximum output by making use of less time, less effort and fewer resources, that is, to create a Lean process. Continual improvement is an important part of every operation […]
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such an approach is to get the maximum output by making use of less time, less effort and fewer resources, that is, to create a Lean process. Continual improvement is an important part of every operation […]
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such an approach is to get the maximum output by making use of less time, less effort and fewer resources, that is, to create a Lean process. Continual improvement is an important part of every operation […]
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such an approach is to get the maximum output by making use of less time, less effort and fewer resources, that is, to create a Lean process. Continual improvement is an important part of every operation […]
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such an approach is to get the maximum output by making use of less time, less effort and fewer resources, that is, to create a Lean process. Continual improvement is an important part of every operation […]
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such an approach is to get the maximum output by making use of less time, less effort and fewer resources, that is, to create a Lean process. Continual improvement is an important part of every operation […]
Sep 04, 2020 The US Food and Drug Administration has issued a warning letter to Mylan Laboratories Limited’s plant in Telangana for significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). USFDA in their letter dated September 1 told the drug-maker that the FDA investigators found lapses in the plant as […]
Lean manufacturing is a methodology to reduce waste in a manufacturing system without sacrificing productivity. Lean manufacturing’s main goal is to eliminate waste. The waste can be categorized into three categories- Mura, Muri and Muda which are commonly known as the 3Ms. In Lean Manufacturing, the 3Ms are considered as the culprit of inefficient processes. […]
Pharmacopoeia is the word derived from the ancient Greek φαρμακοποιΐα (pharmakopoiia), from φαρμακο- (pharmako-) ″drug″, followed by the verb-stem ποι- (poi-) ″make″ and finally the abstract noun ending -ια (-ia). These three elements together can be rendered as ″drug-mak-ing″ or ″to make a drug″. A pharmacopoeia, pharmacopeia, or pharmacopoea, in its modern sense, is a […]
GxP are quality standards and regulations which are to be followed in specific fields. GxP is a concept of good practices where G stands for ‘Good’, x is an acronym which stands for particular field like ‘Manufacturing/Laboratory/Clinical, etc.’ and P stands for ‘Practices’. GxP is a quality benchmark which is a complex practice and which […]
Principles of Quality Risk Management found their application in our day to day life, apart from their application in the industry, production, regulations etc. In pharmaceutical industries principles of QRM found their application for both manufacturers as well as reviewers/ regulators. For manufacturer’s, it should be well understood that regulatory requirements cannot be avoided by […]
Quality Risk Management (QRM) is defined as a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle
July 6, 2020 Gilead Sciences has announced that the European Commission has granted conditional marketing authorization for Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. The conditional marketing authorization was granted in the interest of public health due to the COVID-19 pandemic and was based on a rolling review of supporting […]
Pharmaceutical Good Manufacturing Practices (GMP) thrive on Good Documentation Practices (GDP). It is one of the most important requirements of the Quality Management System. It is popularly said that “Anything which is not documented, is not done”. Documentation is the key to GMP compliance and ensures traceability of various activities viz. development, purchase, storage, dispensing, […]
No manufacturing firm can design a process where they don’t need to hold the various dispensed, in-process, bulk and finished products for few hours to many months. The duration for which the various materials can be hold under specific environmental conditions shall be established by the manufacturer as it directly impacts the product quality. It’s […]
Jun 18, 2020 The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labeled as homeopathic. […]
Jun 17, 2020 Dexamethasone, a low cost corticosteroid available in tablet as well as injectable form has become the first drug to show survival improvement in critically ill cornoavirus patients. As per the study conducted in UK, Researchers found that Dexamethasone reduced deaths by one-third in ventilated patientsand by one fifth in other patients receiving […]
Jun 16, 2020 The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. […]
Quality can be defined as ‘Fitness for Purpose’, i.e.- the products or service should have the right features which satisfies the customers and are thus free from failures (no complaints, no rework etc.). The product should be consistent regarding its conformance and performance which are suited to the customer. Statistically quality can be mentioned to […]
May 21, 2020 Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring. High-quality observational research is an important complement to the evidence on the safety and effectiveness […]
“Higher quality is less expensive to product than lower quality”- W. Edwards Deming Quality comes with a cost. Often we have found companies struggling to strike a fine balance with the quality and cost. Quality managers sometimes struggles to make management understands the financial aspects of quality. Return on Investment is often the question […]
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk Management. It is important to understand that none of the tool or set of tools […]
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk Management. It is important to understand that none of the tool or set of tools […]
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk Management. It is important to understand that none of the tool or set of tools […]
Pharma Industry is a dynamic and highly regulated industry where mistakes, deviations are bound to happen. But what is expected from a quality conscious firm is not to hide the facts but to identify the mistake, report, investigate, identify root cause of the problem, take corrective and preventive actions and document the process as per […]
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk Management. It is important to understand that none of the tool or set of tools […]
Value Stream Mapping (VSM) is a lean technique used in manufacturing to analyze & manage the design and flow of information & materials to provide satisfactory products to the customers. Each step in a process can be documented with the use of specialized flowchart symbols. VSM provides a visual representation of the process from the […]
May 5, 2020 Manufacturing Quality Branch (MQB), Therapeutic Goods Administration (TGA), Australia has notified that they are intending to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-14) issued, 1 July 2018, as the manufacturing principles for medicines, active pharmaceutical ingredients and sunscreens. The TGA’s Manufacturing Quality Branch […]
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk Management. It is important to understand that none of the tool or set of tools […]
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk Management. It is important to understand that none of the tool or set of tools […]
May 1, 2020 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has extended the validity of WHO GMP/ Certificate of Pharmaceutical Product (COPP) expiring from March 2020 to August 2020 by six months from the date of expiry. CDSCO in their Public Notice date 01.05.2020 has stated that “In […]
April 30, 2020 Glenmark Pharmaceuticals announced that it has received the Drugs Controller General (I) permission to conduct clinical trial on Favipiravir. As on date, Glenmark is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in India. Favipiravir is a generic […]
April 28, 2020 The International Coalition of Medicines Regulatory Authorities (ICMRA) on Tuesday has stated “We have stepped up our global collaboration to facilitate and expedite the development and evaluation of diagnostics and therapeutics, including possible vaccines, against SARS-CoV2”. ICMRA is an international executive-level coalition of key regulators from every region in the world. ICMRA […]
Any generic industry thrives on defects reduction, increasing productivity, quality improvement, cost reduction, continual improvement etc. There are various principles or methods available, which helps to achieve our aim of Lean Manufacturing Procedures and Good Manufacturing Practices. We all know a lot about Good Manufacturing Practices popularly known as GMPs. But what about Lean Manufacturing? […]
The aim of any entrepreneur or a manufacturer is to make their venture profitable. Sometimes a person is doing everything right but still at the year end, profits are not that significant if not negative. One thing that most of the young entrepreneur often misses is the identification, evaluation and reduction of wastes being generated […]
April 25, 2020 European Medicines Agency (EMA) has reminded again regarding serious side effects associated with the use of Chloroquine and Hydroxychloroquine in patients suffering from COVID-19. EMA in their bulletin has stated that “Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with […]
Since the arrival of Coronavirus disease, there has been a flood of advices, do’s and dont’s reaching everyone of us. Social media is full of home remedies, talismans and what not to treat and prevent coronavirus disease. By this article we have tried to provide you facts countering the popular myths circulating around more rapidly […]
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk Management. It is important to understand that none of the tool or set of tools […]
Since the advent of Coronavirus disease, the whole world has gone crazy after two things i.e Hand Sanitizers and Face Masks. The fear of the disease has gripped everyone so much that people who didn’t have any exposure to the carrier, are wearing face masks even at home. They are using hand sanitizers like anything. […]
April 18, 2020 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has permitted the conduct of clinical trial of Convalescent Plasma In COVID-19 Patients. The trial protocol was developed and submitted by Indian Council of Medical Research (ICMR), New Delhi. CDSCO in their Public Notice date 17.04.2020 has stated that […]
This is an evident fact that for any industry to grow, it has to constantly improve its processes and quality parameters. This becomes more important in case of highly regulated and constantly advancing industries such as pharmaceutical industry. There are many tools and methods available to identify, investigate, assess and solve quality problems. But […]
Apr 16, 2020 The U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cancer of the lining of the urinary system. “Although our nation’s emphasis is on the need to combat COVID-19, patients with cancer and their unique needs […]
April 15, 2020 World Health Organization (WHO), the United Nations Health Agency has said that there is no considerable evidence to prove that anti-tuberculosis BCG vaccine protects people against infection with COVID19 virus. WHO in their daily bulletin has stated that “There is no evidence that the Bacille Calmette-Guérin vaccine (BCG) protects people against […]
In the previous article entitled Critical Process Parameters (CPP) – What’s the Buzz, we had built an understanding regarding Critical Process Parameters and how their identification and selection is based on Critical Quality Attributes (CQAs) among many other factors. Any manufacturer would like his process to be in a state of complete control, so that […]
In our previous edition to this article entitled “Hand Sanitizer and COVID – 19 – Understanding the Misunderstood”, we had informed you how washing hands with plain soap and water is considered as more effective than hand sanitizers to prevent Corona Virus Infection. Many more queries were raised by our readers in this context. Hence, […]
Pharmaceutical manufacturing is an arduous task. With so many regulations, GMP’s, Quality Concerns, newer products, newer diseases, newer challenges coming up every now and then, it is really required that the professionals involved shall be performing the tasks with utmost care and precision. While designing a manufacturing process, a firm come across so many factors […]
Apr 9, 2020 The Central Drugs Standard Control Organization, Government of India, has requested all State and Union Territory Drug Controllers to expedite the licensure procedure to manufacture oxygen for medical use. This is considered as a welcome move taken in public interest in the wake of outbreak of COVID-19 as supplemental oxygen therapy […]
There is a popular phrase that says “Mistakes are bound to happen”, so do the non-conformances in the pharmaceutical manufacturing. Even if you have validated processes, qualified vendors, qualified equipment, calibrated instruments, in-process checks, SOPs etc. in place, possibility of observing non-conformance or failure to meet pre-defined specifications may not be ruled out completely. So, […]
One of the basic expectations of Quality Management System is to carry out Self Inspection to assess the level of compliance. Carrying out Self Inspection is mandated by almost all the regulators in the world be it USFDA, EU, MHRA, PIC/S, TGA, WHO, CDSCO and many more. What is Self-Inspection/ Internal Audit…? Is […]
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. What has made the matters worse is the mental stress developed due to fear and anxiety of looming uncertainty. This may become more severe and take a toll on the overall health of the individuals who […]
Apr 2, 2020 EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also […]
March 31, 2020 EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to […]
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. Till now, this deadly disease has taken lives of more than 35000 people and more than 750 thousand people are infected worldwide. The virus that causes COVID-19 spreads very easily and sustainably in the community. The […]
February 28, 2020 The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a group of medicines used to treat bacterial infections). “The FDA has a longstanding commitment to […]
Every pharmaceutical manufacturer sometimes goes berserk about ever changing regulations and multiple interpretations of the same guideline by various GMP experts. One of the grey areas is storage of reference and retention samples. This becomes an area of big concern for the pharmaceutical manufacturer handling number of Stock Keeping Units (SKUs). Following questions keep confusing […]
Why Media Fill? During manufacturing of sterile formulations viz. Small Volume Parenteral (SVP), Large Volume Parenteral (LVP), Vaccines and other similar formulations, it is important to ensure that the manufacturing process itself is aseptic. Additionally, it provides another level of assurance that the aseptic environment is being maintained inside the manufacturing area. Hence, it is […]
API FIRST consists of multidisciplinary team of experts who have expertise and experience in wide array of fields related to pharmaceutical manufacturing, GMP experts, regulators, legal experts, medicine and all other related fields associated with manufacturing and sale of pharmaceuticals. This is a one stop destination to quench your thirst for latest Pharma cGMP guidelines […]
API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.