QAHow to Reduce Human Error in Pharmaceutical Operations
Why retraining alone rarely works, and the practical controls that reduce human error in pharmaceutical manufacturing, packaging and documentation.
QC
60 articles
QA
GeneralEnhancing Productivity and Quality in Pharmaceutical Industries
Improving productivity & quality is critical to ensuring efficient operations, regulatory compliance & the delivery of high-quality products
GeneralHow to Utilize 5 WHY Analysis to Uncover Root Cause
5 Whys analysis is an essential tool for identifying the root causes of issues in the pharmaceutical industry
General10 Essential Statistical Tools for Pharmaceutical Analysis: A Guide for Professionals
The use of statistical tools plays a crucial role in ensuring the quality and efficacy of pharmaceutical products.
GeneralHow Can Human Error be Minimized in Pharmaceutical Laboratories and Analyses?
Human error is an unavoidable factor, it poses a significant threat to the credibility and dependability of laboratory findings.
General5WHY Analysis for Pharmaceutical: Uncovering Root Causes Effectively
The 5 WHY analysis stands out as a highly efficient tool for root cause analysis
QAPhotostability Testing of New Drug Products
First Read Photostability Testing of New Drug Substances and Products First Read Photostability Testing of New Drug Substances Photostability Testing of
QAPhotostability Testing of New Drug Substances
drug substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing.
QAPhotostability Testing of New Drug Substances and Products
Photostability Testing of New Drug Substances and Products in pharmaceutical industry
News and UpdatesShutdown of European Pharmacopoeia 10th Edition
European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. all previous versions are no longer been accessible.
News and UpdatesNew paragraph on control of N-nitrosamines, Ph. Eur. revised General Monograph 2034 and 2619
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of a new paragraph on control of N-nitrosamines
Manufacturing and PackagingPastes
Pastes are semisolid preparations of stiff consistency and contain a high percentage 20%–50% of finely dispersed solids. Pastes are intended for
PharmacopoeiaSignal to noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques
Ph. Eur. users are advised to continue calculating the S/N ratio on a window “at least 5 x Wh”, instead of “20 x Wh”.
News and UpdatesRevised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1
EDQM revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders
PharmacopoeiaIMPLANTS
Implants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years
PharmacopoeiaOTHER NONMONOGRAPHED WATERS
In addition to Drinking Water, these waters with various other designations. These include waters of various quality levels...
PharmacopoeiaWATER FOR BACTERIAL ENDOTOXINS TEST
WATER FOR BACTERIAL ENDOTOXINS TEST is also referred as Limulus Amebocyte Lysate (LAL) Reagent Water.
PharmacopoeiaPharmaceutical Dosage Form - Gums
Medicated 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
AMMONIA 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 Oxygen-Free Water is Purified Water that has been treated to remove or reduce dissolved oxygen. Such treatment could involve deaerating
PharmacopoeiaLOSS ON IGNITION
Determining the percentage of test material that is volatilized & driven off under the conditions specified.
PharmacopoeiaDEAERATED WATER
Deaerated Water or “degassed water” is Purified Water that has been treated to reduce the content of dissolved air by “suitable means” ...
PharmacopoeiaHIGH-PURITY WATER
High-Purity Water may be prepared by deionizing previously distilled water and then filtering it through a 0.45-μm rated membrane.
PharmacopoeiaFILTERED WATER
Filtered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis.
PharmacopoeiaLoss on Drying (LOD): Formula, Procedure & USP Limits
Loss on drying is the loss of mass after drying under specified conditions, calculated as a percentage (m/m).
PharmacopoeiaDEIONIZED DISTILLED WATER
This water is used as a reagent in a liquid chromatography test that requires a low ionic or organic impurity level.
PharmacopoeiaDEIONIZED WATER
Deionized 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 Freshly Distilled Water or “recently distilled water” is produced in the same manner as Distilled Water and should be used soon
PharmacopoeiaDISTILLED WATER
Distilled Water is produced by vaporizing Drinking Water or a higher quality of water and condensing it into a purer state.
PharmacopoeiaCARBON DIOXIDE-FREE WATER
Carbon dioxide-free water is defined in the Reagents, Indicators, and Solutions section of USP–NF as Purified Water that has been vigorously boiled for
Manufacturing and PackagingLOTIONS
LOTIONS Lotions are an emulsified liquid dosage form intended for external application to the skin. Historically, some topical suspensions such as
PharmacopoeiaDRINKING WATER
Drinking Water can be referred to as Potable Water, it may be used in the early stages of cleaning pharmaceutical manufacturing equipment.
PharmacopoeiaSOURCE WATER CONSIDERATIONS
Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.
PharmacopoeiaNonmonographed Waters
These waters can also be used in pharmaceutical processing steps & also as a starting material for further purification or testing purposes.
PharmacopoeiaSTERILE WATER FOR INHALATION
STERILE 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 PackagingSTERILE WATER FOR IRRIGATION
is 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 PackagingBACTERIOSTATIC WATER FOR INJECTION
BWI 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
Sterile Water for Injection is water for Injection packaged and rendered sterile.
PharmacopoeiaSTERILE PURIFIED WATER
Sterile Purified Water is Purified Water, packaged and rendered sterile.
PharmacopoeiaSterile Monographed Waters
Sterile Monographed Waters The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized
PharmacopoeiaVOLUMETRIC APPARATUS
Most of the volumetric apparatus available in the United States are calibrated at 20°, and the National Institute of Standards and Technology NIST has
GeneralPure Steam
Pure 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
Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
GeneralWater for Injection
WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled
GeneralPurified Water Monograph
Purified Water Note—For microbiological guidance, see USP general information chapter Water for Pharmaceutical Purposes 1231. H2O 18.02 DEFINITION
GeneralPurified Water [PW]
PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.
GeneralWhat is Difference between Quality Control and Quality Assurance?
What is Difference between Quality Control and Quality Assurance?
General0.1N & 0.1M HCl Preparation: Formula + Calculation Guide
How to calculate the requirement of commercially available Concentrated Hydrochloric Acid to prepare 0.1N or 0.1M HCl Solution?
QCConductivity Meter Calibration: Procedure & Acceptance
Conductivity: It is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present.
Manufacturing and PackagingGUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
News & 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
QAGood Chromatography Practices
Good Chromatography Practices for the pharmaceutical industry
GeneralPersonal Hygiene in Pharmaceuticals: GMP Requirements
Personal hygiene requirements in the pharmaceutical industry
Manufacturing and PackagingFilms PHARMACEUTICAL DOSAGE FORMS
USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
PharmacopoeiaCapsules PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
Manufacturing and PackagingAerosol Dosage Forms: Types, Formulation & Examples
Aerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
Manufacturing and PackagingGood manufacturing practices for medical gases
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
PharmacopoeiaParenteral Dosage Forms: Types, Requirements & Examples
INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS This article is based on the requirement of the United State Pharmacopoeia…
Manufacturing and PackagingGMP INSPECTION RELATED TO PACKAGING
Co-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021
GeneralHappy New year 2021
Pharmaceutical Guideline Wishing Happy New year to you and your family
GeneralPharmaceutical Documentation: Hierarchy, Types & GMP Rules
You might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here.