73 articles
QAThe revised Schedule M is the standard your next inspection will be run against. Which Parts apply to your licence, what is built once for the whole site, what blocks what, and what an inspector asks for in the first four hours.
QAISO 9001:2026 is published and the transition runs to September 2029. What is genuinely new, what was already required before this edition, and what it means if you also work to GMP.
QAWhy retraining alone rarely works, and the practical controls that reduce human error in pharmaceutical manufacturing, packaging and documentation.
GeneralAs of January 2026, the Indian pharma sector faces a massive bottleneck: over 13,000 plants require inspection, yet only ~1,100 field inspectors are active. While the government has enforced Revised Schedule M, Laghu Udhyog Bharti is pushing for a vital extension until December 2026 to prevent the closure of thousands of MSMEs and ensure the continued supply of affordable medicine.
GeneralImproving productivity & quality is critical to ensuring efficient operations, regulatory compliance & the delivery of high-quality products
General5 Whys analysis is an essential tool for identifying the root causes of issues in the pharmaceutical industry
GeneralThe use of statistical tools plays a crucial role in ensuring the quality and efficacy of pharmaceutical products.
GeneralThe 5 WHY analysis stands out as a highly efficient tool for root cause analysis
QAFirst Read Photostability Testing of New Drug Substances and Products First Read Photostability Testing of New Drug Substances Photostability Testing of
QAdrug substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing.
QAPhotostability Testing of New Drug Substances and Products in pharmaceutical industry
21 CFRUpdate on recent changes in 21 CFR (Code of Federal Regulations) On 02nd March 2023; The text of § 11.100 General requirements of Subpart C Electronic…
News and UpdatesIntended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
Manufacturing and PackagingDraft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
Manufacturing and PackagingPastes are semisolid preparations of stiff consistency and contain a high percentage 20%–50% of finely dispersed solids. Pastes are intended for
Manufacturing and PackagingWHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
PharmacopoeiaPh. Eur. users are advised to continue calculating the S/N ratio on a window “at least 5 x Wh”, instead of “20 x Wh”.
PharmacopoeiaImplants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years
PharmacopoeiaIn addition to Drinking Water, these waters with various other designations. These include waters of various quality levels...
PharmacopoeiaWATER FOR BACTERIAL ENDOTOXINS TEST is also referred as Limulus Amebocyte Lysate (LAL) Reagent Water.
PharmacopoeiaMedicated gum is a pliable dosage form that is designed to be chewed rather than swallowed. it Release the drug substances into the saliva.
PharmacopoeiaAMMONIA FREE WATER From a functional standpoint, Ammonia Free Water must have a negligible ammonia concentration to avoid interference in tests sensitive
PharmacopoeiaOXYGEN FREE WATER Oxygen-Free Water is Purified Water that has been treated to remove or reduce dissolved oxygen. Such treatment could involve deaerating
PharmacopoeiaDeaerated Water or “degassed water” is Purified Water that has been treated to reduce the content of dissolved air by “suitable means” ...
PharmacopoeiaHigh-Purity Water may be prepared by deionizing previously distilled water and then filtering it through a 0.45-μm rated membrane.
PharmacopoeiaFiltered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis.
PharmacopoeiaThis water is used as a reagent in a liquid chromatography test that requires a low ionic or organic impurity level.
PharmacopoeiaDeionized Water is produced by an ion-exchange process in which the cations & anions are replaced with H+ & OH− ions by use of ion-exchange
PharmacopoeiaFRESHLY DISTILLED WATER Freshly Distilled Water or “recently distilled water” is produced in the same manner as Distilled Water and should be used soon
PharmacopoeiaDistilled Water is produced by vaporizing Drinking Water or a higher quality of water and condensing it into a purer state.
PharmacopoeiaCarbon dioxide-free water is defined in the Reagents, Indicators, and Solutions section of USP–NF as Purified Water that has been vigorously boiled for
PharmacopoeiaDrinking Water can be referred to as Potable Water, it may be used in the early stages of cleaning pharmaceutical manufacturing equipment.
PharmacopoeiaSource water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.
PharmacopoeiaThese waters can also be used in pharmaceutical processing steps & also as a starting material for further purification or testing purposes.
PharmacopoeiaSTERILE WATER FOR INHALATION is Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of
Manufacturing and Packagingis Water for Injection packaged and sterilized in single-dose containers that may be larger than 1 L & allow rapid delivery of their content
Manufacturing and PackagingBWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.
Manufacturing and PackagingSterile Water for Injection is water for Injection packaged and rendered sterile.
PharmacopoeiaSterile Purified Water is Purified Water, packaged and rendered sterile.
PharmacopoeiaSterile Monographed Waters The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized
GeneralPure Steam— is also sometimes referred to as “clean steam”. It is used where the steam or its condensate would directly contact official articles or
GeneralWater for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
GeneralWFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled
GeneralPurified Water Note—For microbiological guidance, see USP general information chapter Water for Pharmaceutical Purposes 1231. H2O 18.02 DEFINITION
GeneralPW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.
GeneralWATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
QAPeriodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained
QATo check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
QAOperational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
QAThe performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.
QASite Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.
QAFactory Acceptance Test (FAT) for Equipment, Utility, System, Facility in the pharmaceutical industry.
GeneralWhat is Difference between Quality Control and Quality Assurance?
QADesign Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…
QAUser Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry
QABasic Flow of Qualification [Equipment, Utility, System, Facility], URS, DQ, FAT, SAT, IQ, OQ, PQ
GeneralVALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process.
GeneralStandard operating procedures (SOPs) are the detailed written instructions that specify how a test or administrative procedure is to be performed, or how a piece of equipment is operated, maintained and calibrated. SOPs describe the \"standard\" approved procedures that are routinely carried out in a GMP facility. They indicate exactly how things are done and are kept current by review and approved revision on a predetermined schedule
Manufacturing and PackagingNews & UpdatesPIC/S [PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME] has revised guideline No. PE 009-16 [GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS] on 1 February 2022.Key Revision: • Revision of Annex 13 • Annex 13 (Manufacture of investigational medicinal products) • New Annex added • Annex 16 (Authorised person and batch release)Click Here to Download the Guideline Our Dynamic Pharma Team is providing a step-by-step learning topic on this website.You will find Short No
GeneralGranules; a General Chapter of British Pharmacopoeia BP and Europian Pharmacopoeia Ph Eur
QAGood Chromatography Practices for the pharmaceutical industry
GeneralPersonal hygiene requirements in the pharmaceutical industry
Manufacturing and PackagingUSP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
PharmacopoeiaCapsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
Manufacturing and PackagingAerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
Manufacturing and PackagingWorking document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
QACo-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021
Manufacturing and PackagingCo-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021
QAPharmaceutical Inspection Co-operation Scheme (PIC/S) Leading the international development, implementation, and maintenance of harmonized GMP standards…
GeneralIn this article, we will discuss a practical approach to prepare the Site Master File (SMF) for the Pharmaceutical Industry. We have to understand that The SMF is the document which explains your organization; it creates the image of the organization, So it should be self-explanatory as in most of the case you are not present to explain the SMF.Do you believe that the SMF is creating the first impression of your organization before visiting your Site…After discussing with various regulatory auth
GeneralPharmaceutical Guideline Wishing Happy New year to you and your family
GeneralYou might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here.
GeneralIn this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance…
