Central Drugs Standard Control Organization (CDSCO), Government of India has a mandate for approval of drugs to be manufactured and...
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Mosquiorix becomes first malaria vaccine to receive WHO prequalification
22 September, 2022 In a historic development, World Health Organization (WHO) has granted prequalification to malaria vaccine developed by...
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India publishes Drugs Medical Devices and Cosmetics Bill
9 July, 2022 The Ministry of Health and Family Welfare, Government of India has published a draft of New Drugs,...
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CDSCO has published draft guidelines for IVDMD
9 July, 2022 Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has published...
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Potential problems during Audit
In our series regarding various auditing techniques, we have touched upon many topics namely qualities of an Auditor, time management...
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Solubility of Active Pharmaceutical Ingredients
Solubility is the capacity of the solvent to dissolve a solute. Solutes may differ in both the extent and the...
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CDSCO publishes list of approved COVID-19 vaccines in India
18 June, 2022 Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has...
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CDSCO issues draft notification for Schedule H2 drugs
17 June, 2022 Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has...
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CDSCO waives off requirement of TSE BSE certification
17 June, 2022 Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has issued...
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Test License for drugs in India
Indian drug regulatory system is governed by the provisions laid down under Drugs and Cosmetics Act, 1940 and Rules,...
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Nuances of conducting interview during audit
In our series regarding various auditing techniques, we have touched upon many topics namely qualities of an Auditor, time management...
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CDSCO extends timeline for FDC regularization
April 30, 2022 Central Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health and Family Welfare,...
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CDSCO granted restricted EUA to vaccinate children
April 26, 2022 Central Drugs Standard Control Organization (CDSCO), the Drug Regulatory Agency of Government of India granted restricted...
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Communication during Audit
Communication may be defined as transferring meaningful information to produce greater understanding. The exchange of information or passing of information,...
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CDSCO publishes updated list of banned drugs in India
Central Drugs Standard Control Organization, Government of India has recently published their updated list of banned drugs in India. The...
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Online Drug Licensing process in India – Portal Registration
India has been moving from offline application process to completely online applications especially in terms of applications related to licensure...
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Conflict Management among Audit team during Audit
As discussed in our previous blog entitled “Conflict management During Audit”, even after taking utmost care, conflicts do happen among...
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Conflict Management during audit
Conflict is defined as a clash between individuals arising out of a difference in thought process, attitudes, understanding, interests, requirements...
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Time Management during Audit
Time management is a feature with which we all struggle throughout our lives. Time management during an audit is the...
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Auditor – Blend of knowledge and skills
Being an Auditor requires a skillset which is way beyond the technical competence. An auditor shall have certain natural and...
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ISO 22301: Maintaining Business Continuity
Business Continuity is an issue that affects all organizations whether small or large, domestic or multinational. The extent of impact...
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Types of Glass used for Pharmaceutical Packaging
Glass containers used in pharmaceutical preparations are intended to come into direct contact with pharmaceutical preparations. Glass containers shall have...
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Britain has become the first country to approve Lagevrio (Molnupiravir)
Nov, 7 2021 Britain has become the first country in the world to approve Lagevrio (molnupiravir). The drug is touted...
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Ethics Committee Regulations in India
Ethics Committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an...
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Mutual Recognition Agreement
Pharma is a highly regulated industry. Regulatory audits are an integral part of the drug regulations. Any pharmaceutical industry having...
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Reference Standard for testing pharmaceuticals
Testing of identity, strength, quality and purity of pharmaceuticals such as drug substances, excipients and products requires them to be...
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Pathway for regularization of FDCs declared as rational
Central Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health and Family Welfare, Government of India has...
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Impurities in Pharmaceutical preparation
Going by the classical definition, an impurity can be defined as an unwanted chemical substance which differs from the chemical...
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USFDA approved the first fully licensed COVID19 vaccine
Aug, 23 2021 USFDA approved the first fully licensed COVID19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19...
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Audit – An Integral Part of Organization Success
“Audit is a systematic, independent, and documented assessment to determine whether agreed upon requirements are being met and will continue...
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Friability Testing of Granules and Spheroids
In continuation to our previous article entitled "Friability testing of tablets", we are hereby providing you the guidelines on...
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India introduces alternative rapid microbiological methods to expedite the supply of Remdesivir injection
April 21, 2021 Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Government of India has introduced a new...
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Friability Testing of Tablets
The tablets manufactured by a firm needs to be sufficiently hard to bear the shocks experienced during their packing and...
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WHO revised stability conditions for member states
World Health Organization (WHO) in March, 2021 has come up with revised stability conditions for WHO Member States. The list...
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Data Integrity and Principles of ALCOA and ALCOA+
Against the backdrop of globalization, especially in case of pharmaceutical industry, data integrity has become one of the basic expectations...
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Government of India launches Online National Drug Licensing System (NDLS) portal for filing of drug applications
Apr 02, 2021 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has come up...
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New Drug Approval Process in India
India is a country which has a drug regulatory system operating at the Central Level as well as the State...
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Chronicles of FDC Ban in India
Indian Pharma Sector often boasts about being known as Pharmacy of the World. There is no doubt that Indian pharma...
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Periodic or Skip Testing
As per regulatory requirements, each API, inactive ingredient, finished good, packing material and other related material shall be tested as...
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Parametric Release
Parametric release is defined as the system of release that gives the assurance that the product is of the intended...
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Pharmaceutical Specifications
The whole pharma world goes berserk in meeting the ‘product specifications’ as required by various regulatory authorities. Pharmacopeial specifications, In-house...
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Site Master File – The Gateway to Manufacturing Site
As a part of regulatory requirements, we prepare numerous documents. Preparing documents shall not be treated as a burden but...
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Product Quality Review
Pharmaceuticals in general not only produce drugs but they also produce tons of data. Regulatory agencies across the globe insist...
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Pharmaceutical Product Inspection
Pharmaceutical products are manufactured with an objective of meeting their predefined objectives of quality, safety and efficacy. However, how hard...
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Product and Container Considerations for Manual Visual Inspection of Pharmaceuticals
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The...
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USFDA approves first treatment for COVID 19
Oct, 24 2020 Gilead Lifesciences Inc.'s Veklury (Remdesivir) has become the first treatment for COVID-19 to receive the U.S. Food...
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Qualification and Validation of Visual Inspectors and Inspection Processes
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The...
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Container Handling during Manual Visual Inspection of Pharmaceuticals
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The...
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Inspection Rate for Manual Visual Inspection of Pharmaceuticals
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The...
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Lighting requirement for Manual Visual Inspection of Pharmaceuticals
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The...
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Disposal of Drug Products and other Pharma Waste
The management and disposal of the waste produced in a pharmaceutical manufacturing firm has always been a matter of concern....
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Management of Returned and Salvaged Goods
The objective of any pharmaceutical manufacturing firm is to manufacture a product which fulfils all the requirements of being a...
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Overall Equipment Effectiveness – Lean Tool for Improvement of Process Effectiveness and Efficiency
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such...
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TPM – Lean Tool for Improvement of Process Effectiveness and Efficiency
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such...
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SMED – Lean Tool for Improvement of Process Effectiveness and Efficiency
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such...
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Kanban – Lean Tool for Improvement of Process Effectiveness and Efficiency
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such...
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Gemba – Lean Tool for Improvement of Process Effectiveness and Efficiency
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such...
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Jidoka – Lean Tool for Improvement of Process Effectiveness and Efficiency
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such...
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Poka-Yoke – Lean Tool for improvement of Process Effectiveness and Efficiency
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such...
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Kaizen – Lean Tool for improvement of Process Effectiveness and Efficiency
Lean manufacturing makes use of various lean tools for improvement in production effectiveness and efficiency. The main goal of such...
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FDA issues warning letter to Mylan’s API manufacturing site
Sep 04, 2020 The US Food and Drug Administration has issued a warning letter to Mylan Laboratories Limited's plant in...
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3Ms of Lean Manufacturing
Lean manufacturing is a methodology to reduce waste in a manufacturing system without sacrificing productivity. Lean manufacturing’s main goal is...
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Unfolding the Pharmacopoeia – I
Pharmacopoeia is the word derived from the ancient Greek φαρμακοποιΐα (pharmakopoiia), from φαρμακο- (pharmako-) ″drug″, followed by the verb-stem ποι-...
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GxP: The 5 Ps of Good Practices
GxP are quality standards and regulations which are to be followed in specific fields. GxP is a concept of good...
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Applications of Quality Risk Management
Principles of Quality Risk Management found their application in our day to day life, apart from their application in the...
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Quality Risk Management
Quality Risk Management (QRM) is defined as a systematic process for the assessment, control, communication and review of risks to...
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European Commission Grants Conditional Marketing Authorization to Veklury® for the Treatment of COVID-19
July 6, 2020 Gilead Sciences has announced that the European Commission has granted conditional marketing authorization for Veklury® (remdesivir) as a...
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GMP Document Management – Documentation Hierarchy
Pharmaceutical Good Manufacturing Practices (GMP) thrive on Good Documentation Practices (GDP). It is one of the most important requirements of...
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Hold Time Study
No manufacturing firm can design a process where they don’t need to hold the various dispensed, in-process, bulk and finished...
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FDA Warns Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic
Jun 18, 2020 The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable...
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Dexamethasone – First drug to show survival improvement in COVID-19
Jun 17, 2020 Dexamethasone, a low cost corticosteroid available in tablet as well as injectable form has become the first...
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FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
Jun 16, 2020 The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine...
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Quality – A journey from mere concept to principle of life
Quality can be defined as ‘Fitness for Purpose’, i.e.- the products or service should have the right features which satisfies...
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Global regulators commit to cooperate on observational research in the context of COVID-19
May 21, 2020 Regulators from around the world have agreed three priority areas for cooperation on observational research during...
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Total Cost of Quality – Quality is always Cheap
“Higher quality is less expensive to product than lower quality”- W. Edwards Deming Quality comes with a cost. Often...
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Preliminary Hazard Analysis (PHA) – Quality Risk Management Tool
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks...
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Hazard and Operability Analysis (HAZOP) – Quality Risk Management Tool
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks...
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Failure Mode, Effects and Criticality Analysis (FMECA) -Quality Risk Management Tool
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks...
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5 WHY – Simplest way to root cause identification
Pharma Industry is a dynamic and highly regulated industry where mistakes, deviations are bound to happen. But what is expected...
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Risk Ranking and Filtering (RRF) – Quality Risk Management Tool
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks...
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Value Stream Mapping (VSM)
Value Stream Mapping (VSM) is a lean technique used in manufacturing to analyze & manage the design and flow of...
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TGA to adopt the current version of the PIC/S Guide to GMP for Medicinal Products
May 5, 2020 Manufacturing Quality Branch (MQB), Therapeutic Goods Administration (TGA), Australia has notified that they are intending to adopt...
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Hazard Analysis and Critical Control Point (HACCP) – Quality Risk Management Tool
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks...
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Fault Tree Analysis (FTA) – Quality Risk Management Tool
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks...
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Indian Regulator extends validity of Certificate of Pharmaceutical Product (COPP) to facilitate Pharmaceutical Industry
May 1, 2020 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has extended the...
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Glenmark Pharmaceuticals received Indian Drug Regulator’s nod to conduct clinical trial on Favipiravir
April 30, 2020 Glenmark Pharmaceuticals announced that it has received the Drugs Controller General (I) permission to conduct clinical...
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International Coalition of Regulators pledged its collective support in countering the COVID-19 pandemic
April 28, 2020 The International Coalition of Medicines Regulatory Authorities (ICMRA) on Tuesday has stated “We have stepped up our...
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5S – Lean Manufacturing or Good Manufacturing..??
Any generic industry thrives on defects reduction, increasing productivity, quality improvement, cost reduction, continual improvement etc. There are various principles...
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Waste Management in Pharma – Manufacture Lean and Make it a Routine
The aim of any entrepreneur or a manufacturer is to make their venture profitable. Sometimes a person is doing everything...
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EMA reminds of risk of serious side effects with Chloroquine and Hydroxychloroquine
April 25, 2020 European Medicines Agency (EMA) has reminded again regarding serious side effects associated with the use of Chloroquine...
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Coronavirus Disease – Myths Buster
Since the arrival of Coronavirus disease, there has been a flood of advices, do's and dont's reaching everyone of us....
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Failure Mode Effects Analysis (FMEA) – Quality Risk Management Tool
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks...
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Face Masks and COVID 19 – Unmasking the masked
Since the advent of Coronavirus disease, the whole world has gone crazy after two things i.e Hand Sanitizers and Face...
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Indian Regulator Permits Clinical Trial of Convalescent Plasma In COVID-19 Patients
April 18, 2020 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has permitted the conduct...
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7 Basic Quality Control (QC) Tools – Steps to process improvement
This is an evident fact that for any industry to grow, it has to constantly improve its processes and...
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USFDA Approves Jelmyto as First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer
Apr 16, 2020 The U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade...
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No Evidence to prove that BCG vaccine protects people against infection with COVID19 virus – WHO
April 15, 2020 World Health Organization (WHO), the United Nations Health Agency has said that there is no considerable...
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Critical Quality Attributes (CQA) – What’s the Buzz
In the previous article entitled Critical Process Parameters (CPP) – What’s the Buzz, we had built an understanding regarding Critical...
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Hand Sanitizer and COVID – 19 – Understanding the Misunderstood – Part 2
In our previous edition to this article entitled “Hand Sanitizer and COVID – 19 – Understanding the Misunderstood”, we had...
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Critical Process Parameter (CPP) – What’s the Buzz
Pharmaceutical manufacturing is an arduous task. With so many regulations, GMP’s, Quality Concerns, newer products, newer diseases, newer challenges coming...
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Government of India expedited the Licensure procedure for manufacturing Oxygen for Medical Use
Apr 9, 2020 The Central Drugs Standard Control Organization, Government of India, has requested all State and Union Territory...
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Reprocessing and Reworking – From Confusion to Clarity
There is a popular phrase that says “Mistakes are bound to happen”, so do the non-conformances in the pharmaceutical manufacturing....
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Self-Inspection – Expressway to Compliance
One of the basic expectations of Quality Management System is to carry out Self Inspection to assess the level...
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Mental Stress and COVID 19 – Avoid the Avoidable
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. What...
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EMA recommends to restrict use of fosfomycin antibiotics
Apr 2, 2020 EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be...
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EU adopted new Strategy – Regulatory Science Strategy 2025
March 31, 2020 EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing...
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Hand Sanitizer and COVID – 19 – Understanding the Misunderstood
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. Till...
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FDA Approves First Generic of Daraprim
February 28, 2020 The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine)...
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Reference and Retention Samples – Regulatory Perspective
Every pharmaceutical manufacturer sometimes goes berserk about ever changing regulations and multiple interpretations of the same guideline by various GMP...
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Media Fill Validation – Regulatory Approach
Why Media Fill? During manufacturing of sterile formulations viz. Small Volume Parenteral (SVP), Large Volume Parenteral (LVP), Vaccines and other...
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Introduction
API FIRST consists of multidisciplinary team of experts who have expertise and experience in wide array of fields related to...
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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.