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Pharmaceutical Guideline

Interview Preparation

53 articles tagged “Interview Preparation”

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.

CARBON 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

LOTIONS

LOTIONS Lotions are an emulsified liquid dosage form intended for external application to the skin. Historically, some topical suspensions such as

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.

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 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

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 Monographed Waters

Sterile Monographed Waters The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized

VOLUMETRIC 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

Emulsions

An emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents

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 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.

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

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.

Design Qualification [DQ]

Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…

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.