Enhancing Productivity and Quality in Pharmaceutical Industries
Improving productivity & quality is critical to ensuring efficient operations, regulatory compliance & the delivery of high-quality products
Quality Control
51 articles tagged “Quality Control”
How 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
5WHY Analysis for Pharmaceutical: Uncovering Root Causes Effectively
The 5 WHY analysis stands out as a highly efficient tool for root cause analysis
Photostability Testing of New Drug Substances
drug substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing.
Photostability Testing of New Drug Substances and Products
Photostability Testing of New Drug Substances and Products in pharmaceutical industry
Changes in 21 CFR Part 11 Subpart C, Electronic Signatures
Update 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…
Shutdown 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.
New 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
WHO TRS 1044 (2022): 56th Report Annexes & PDF
WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
Signal 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”.
Revised 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
IMPLANTS
Implants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years
OTHER NONMONOGRAPHED WATERS
In addition to Drinking Water, these waters with various other designations. These include waters of various quality levels...
WATER FOR BACTERIAL ENDOTOXINS TEST
WATER FOR BACTERIAL ENDOTOXINS TEST is also referred as Limulus Amebocyte Lysate (LAL) Reagent Water.
Pharmaceutical 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.
LOSS ON IGNITION
Determining the percentage of test material that is volatilized & driven off under the conditions specified.
HIGH-PURITY WATER
High-Purity Water may be prepared by deionizing previously distilled water and then filtering it through a 0.45-μm rated membrane.
FILTERED WATER
Filtered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis.
Loss 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).
DEIONIZED DISTILLED WATER
This water is used as a reagent in a liquid chromatography test that requires a low ionic or organic impurity level.
DEIONIZED 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
DISTILLED WATER
Distilled Water is produced by vaporizing Drinking Water or a higher quality of water and condensing it into a purer state.
DRINKING WATER
Drinking Water can be referred to as Potable Water, it may be used in the early stages of cleaning pharmaceutical manufacturing equipment.
SOURCE WATER CONSIDERATIONS
Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.
Nonmonographed Waters
These waters can also be used in pharmaceutical processing steps & also as a starting material for further purification or testing purposes.
STERILE 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
BACTERIOSTATIC WATER FOR INJECTION
BWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.
Sterile Water for Injection
Sterile Water for Injection is water for Injection packaged and rendered sterile.
STERILE PURIFIED WATER
Sterile Purified Water is Purified Water, packaged and rendered sterile.
Emulsions
An emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents
Water for Hemodialysis
Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
Water for Injection
WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled
Purified Water [PW]
PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
Factory Acceptance Test (FAT) in Pharma: Checklist & Scope
Factory Acceptance Test (FAT) for Equipment, Utility, System, Facility in the pharmaceutical industry.
What is Difference between Quality Control and Quality Assurance?
What is Difference between Quality Control and Quality Assurance?
Conductivity 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.
Granules Dosage Form: Definition, Types & Advantages
Granules; a General Chapter of British Pharmacopoeia BP and Europian Pharmacopoeia Ph Eur
Good Chromatography Practices
Good Chromatography Practices for the pharmaceutical industry
Films PHARMACEUTICAL DOSAGE FORMS
USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
Aerosol Dosage Forms: Types, Formulation & Examples
Aerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
Pharmaceutical Dosage Forms: Complete Classification List
〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.
Good manufacturing practices for medical gases
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
Parenteral 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…
INSPECTION OF UTILITIES
Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021
GMP INSPECTION RELATED TO PACKAGING
Co-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021
Site Master File (SMF): WHO Format, Contents & Example
In 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
Pharmaceutical 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.
Quality Policy for Pharmaceutical Industry
In this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance…
JOB in Pharma
Pharmaceutical Industry contributes to improving the health and wellbeing of society.