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Quality

Cleaning Validation : Procedure & Protocol

Standard operating Procedure & Protocol for Cleaning Validation to prove that the equipment cleaning procedure can repeatedly and reproducibly remove… Read More

Method Verification (Analytical) Procedure (USP1226)

Standard Operating Procedure for performing analytical method verification of compendial procedure/ validated analytical methods in quality control department. Describes characteristics… Read More

Laboratory Glassware Cleaning of Procedure

Standard Operating Procedure (SOP) for Cleaning of Laboratory Glassware. Occasionally, more aggressive cleaning solutions may be necessary when laboratory glassware… Read More

Viscometer – Operation and Calibration Procedure

Standard Operating Procedure (SOP) for Operation and Calibration of Brookfield make Viscometer used to determine the viscosity of solution /… Read More

Polarimeter – Operation and Calibration Procedure

Standard Operating Procedure (SOP) for Operation and calibration of Polarimeter used to determine of optical rotation of raw material in… Read More

UV-Visible Spectrophotometer – Calibration

Standard Operating Procedure (SOP) for Operation and Calibration of UV-Visible Spectrophotometer used for Qualitative and Quantitative analysis of starting material… Read More

FTIR Spectrophotometer – Operation & Calibration

Standard Operating Procedure (SOP) for Operation and Calibration of FTIR Spectrophotometer used for identification test of starting material (RM) and… Read More

Microbial Cultures – Isolation and Identification Guide

Procedure for Isolation and Identification of Microbial Cultures & Microbial Isolates using different Analytical Methods from the manufacturing environment of… Read More

Failure Investigation Procedure and Tools

Standard Operating Procedure (SOP) for Failure Investigation (process failure as well as non-process failure) occurs during manufacturing or processing of… Read More

Analytical Method Transfer – Acceptance Criteria

This SOP describes the process and requirements for the transfer of analytical test method from an originating laboratory (Transferring Unit)… Read More

Microbiological Analysis of Water – Procedure

Standard Operating Procedure for Microbiological Analysis of Water used for manufacturing of various drug product in pharmaceutical industry. Procedure for… Read More

Environmental Monitoring : Microbiological Analysis

Guideline and Formats for Microbiological Environmental Monitoring (EM) of various area like in Production, Microbiology laboratory, Dispensing & Sampling Area,… Read More

Subculturing (Cell Passaging) in Microbiology Lab

Standard operating Procedure for Subculturing (Cell Passaging) in microbiology and its maintenance. Subculturing also referred to as passaging cells, is… Read More

Media Preparation for Microbiological Analysis

Standard Operating Procedure (SOP) for Microbiological Media Preparation. Media are required for cultivating the Micro-Organism. Microbiology Media should be prepared… Read More

Microbial limit test (MLT) – Testing Procedure

The Microbial limit test (MLT) is performed to assess how many and which of certain viable microorganisms are present in… Read More

Vibro Sifter – Procedure for Cleaning and Operation

Standard Operating Procedure for Cleaning and Operation of Vibro Sifter. Pharmaceutical Vibro Sifter is used to separate mass composition of solids, liquid from solid… Read More

Melting Point Apparatus – Operation & Calibration

Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus in Quality Control Laboratory. Melting Point Apparatus 1.0 … Read More

Analyst Qualification of Quality Control Personnel

Standard Operation Procedure (SOP) of providing training and qualification of analyst for all new appointed personnel, and existing employees who… Read More

Working Standard Qualification Procedure

Guideline for Laboratory Standard Management (Preparation, Qualification and Handling of Analytical standards/Working Standard/Primary Standard etc.) Working Standard Management 1.0   Objective… Read More

Raw Material Sampling Procedure-API & Excipient

Standard Operating Procedure (SOP) and Guideline for sampling of raw material (API and Excipient) / Starting material for analysis. Raw… Read More