In our series regarding various auditing techniques, we have touched upon many topics namely qualities of an Auditor, time management during audit, conflict management during audit, interviewing techniques and various types of communications during audit etc. In the present article, we shall be discussing about the potential problems that may arise during the conduct of […]
Solubility is the capacity of the solvent to dissolve a solute. Solutes may differ in both the extent and the rate at which they dissolve in a solvent. The solubility of one substance in another is a measure of the degree of molecular mixing between the two pure substances at thermodynamic equilibrium. The composition of […]
In our series regarding various auditing techniques, we have touched upon many topics namely qualities of an Auditor, time management during audit, conflict management during audit and various types of communications during audit etc. In the present article, we shall be discussing about nuances of conducting interview during audit. Interviewing is the most challenging but […]
Communication may be defined as transferring meaningful information to produce greater understanding. The exchange of information or passing of information, ideas or thought from one person to the other or from one end to the other is communication. Lot of communication do happen before an audit, during an audit and post audit. Poor or inadequate […]
India has been moving from offline application process to completely online applications especially in terms of applications related to licensure and product approvals of drugs, new drugs, medical devices, cosmetics, etc. We will hereby be providing you with series of articles helping you to understand the Online Drug Licensing process in India. The online drug […]
As discussed in our previous blog entitled “Conflict management During Audit”, even after taking utmost care, conflicts do happen among auditor and auditee. However rare, but possibility of conflict among the audit team cannot be ruled out. Conflict among auditors normally stem from lack of communication, misunderstanding, misinterpretation, lack of experience, close mindedness etc. Conflict […]
Conflict is defined as a clash between individuals arising out of a difference in thought process, attitudes, understanding, interests, requirements and even sometimes perceptions. Disagreements among individuals lead to conflicts and fights. An audit is a process if not handled well will turn the audit room into a battle ground as often difference of opinions, requirements, understandings […]
Time management is a feature with which we all struggle throughout our lives. Time management during an audit is the most challenging task that any audit team faces. Audit is always time bound activity in which we normally have to cover various sections, review bulk of documentation, on-site visit to various areas related to processing, […]
Being an Auditor requires a skillset which is way beyond the technical competence. An auditor shall have certain natural and acquired skills to conduct an effective audit. Being an auditor requires someone to be highly professional and effective in using his knowledge and skills. In short an auditor shall be a perfect blend of technical […]
Business Continuity is an issue that affects all organizations whether small or large, domestic or multinational. The extent of impact however may vary from organization to organization. Recently, we have witnessed a global pandemic which has disrupt almost all type of businesses. Natural disasters, environmental accidents, technology mishaps, and man-made crises have demonstrated that severe […]
Glass containers used in pharmaceutical preparations are intended to come into direct contact with pharmaceutical preparations. Glass containers shall have a proper closure system. The containers are designed in a manner that the removal of contents is hassle free and is appropriate to the intended use of the preparation. Glass containers provides a varying degree […]
Ethics Committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international laws. Central Drugs Standard Control Organization, the national drug regulatory authority has published various regulations applicable for Ethics Committee in India. New Drugs and Clinical Trial Rules, […]
Pharma is a highly regulated industry. Regulatory audits are an integral part of the drug regulations. Any pharmaceutical industry having a global presence undergo numerous audits in a year by various regulatory agencies. This not only affects their productivity but also the agencies have to spend their financial resources and deploy manpower to conduct these […]
Testing of identity, strength, quality and purity of pharmaceuticals such as drug substances, excipients and products requires them to be compared with a substance which is highly purified and characterized. The US Pharmacopeia (USP) defines reference standard materials as “highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators”. […]
Going by the classical definition, an impurity can be defined as an unwanted chemical substance which differs from the chemical composition of the material in question. In pharmaceutical preparations, impurities identification, assessment and quantification play a vital role in evaluating the quality of the drug substance or drug product being manufactured. To understand the concept […]
“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 […]
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 […]
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 […]
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 […]
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
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 […]
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 […]
“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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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.