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
Interview Preparation
45 articles tagged “Interview Preparation”
Departments in the Biopharmaceutical Industry
Departments in biopharmaceutical industry, its work function in details, how to get job in biopharmaceuticals, eligibility criteria, Salary.
How to Secure a Job in the Pharmaceutical Industry: Eligibility, Preparation, and Interview Tips
Its essential to not only meet the eligibility criteria but also to showcase your passion for the industry & willingness to learn and grow.
Code of Federal Regulations, CFR
The list of titles of the Code of Federal Regulations The 21 CFR is the Title 21 for Food and Drugs
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.
CREAMS
Creams are semisolid emulsion dosage forms, Creams are generally intended for external application to the skin or to the mucous membranes
SOURCE WATER CONSIDERATIONS
Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.
Multiple Endpoints in Clinical Trials Guidance for Industry
GUIDANCE DOCUMENT Multiple Endpoints in Clinical Trials Guidance for Industry OCTOBER 2022 Docket Number: FDA-2016-D-4460 Issued by: Center for Biologics…
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
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.
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
Performance Qualification (PQ): Protocol, Steps & Examples
To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
Operational Qualification (OQ): Protocol, Tests & Examples
Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
Installation Qualification [IQ]
The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.
Site Acceptance Test [SAT]
Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.
Major Equipment of Tablets and Capsules Manufacturing
List of Major Equipment of Tablets and Capsules Manufacturing
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?
Design Qualification [DQ]
Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…
0.1N & 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?
User Requirement Specification (URS) in Pharma + Template
User Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry
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.
SOPs in Pharmaceuticals: Format, Structure & Writing Guide
Standard 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
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
Personal Hygiene in Pharmaceuticals: GMP Requirements
Personal hygiene requirements in 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.
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
QRM Implementation: PIC/S Aide-Mémoire & Assessment Guide
Pharmaceutical Inspection Co-operation Scheme (PIC/S) Leading the international development, implementation, and maintenance of harmonized GMP standards…
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.
Departments in the Pharmaceutical Industry: List & Roles
Basic Work functions of the key Departments in the Pharmaceutical Industry
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.