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Pharmaceutical Guideline

Pharma Learning

29 articles tagged “Pharma Learning”

Pure 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

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 Monograph

Purified Water Note—For microbiological guidance, see USP general information chapter Water for Pharmaceutical Purposes 1231. H2O 18.02 DEFINITION

Purified Water [PW]

PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.

Periodic Review and Requalification

Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained

VALIDATION MASTER PLAN (VMP)

VALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process.

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

INSPECTION OF UTILITIES

Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES 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

JOB in Pharma

Pharmaceutical Industry contributes to improving the health and wellbeing of society.