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Tag: Quality Control

SOP for Handling of Laboratory Reagents

September 16, 2020 Admin Leave a comment

Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC.…

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Posted in: Quality Control, SOP Filed under: Handling Reagents, Quality Control, Quality Control SOP

Acceptable Quality Level (AQL) – SOP and Chart

September 12, 2020 Admin Leave a comment

OBJECTIVE: To define the procedure for Acceptable Quality Level sampling for Tablets and Capsules during bulk approval. SCOPE: This procedure…

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Posted in: Quality Control Filed under: AQL, Quality Control, Quality Control SOP

SOP for Polarimeter

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Purpose: The purpose of this SOP is to describe the procedure for operation, cleaning, and calibration of the polarimeter.  …

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Posted in: SOP Filed under: cleaning, Quality Control, Quality Control SOP, The purpose of this SOP is to describe the procedure for operation

Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter

September 11, 2020 Admin Leave a comment

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated July 23, 2020, to Tender Corporation. The…

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Posted in: FDA Warning Letter Filed under: FDA Warning Letter, Quality Control, Unofficial HPLC Injection, USFDA Audit

SOP OF GOOD CHROMATOGRAPHY PRACTICES

September 10, 2020 Admin Leave a comment

Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile…

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Posted in: Quality Control Filed under: GOOD CHROMATOGRAPHY PRACTICES, Quality Control, Quality Control SOP

SOP For FTIR

September 7, 2020 Admin Leave a comment

Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning, and Maintenance of FTIR (Fourier Transform Infrared Spectrometer). Procedure for Operation and…

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Posted in: Quality Control Filed under: FTIR, Quality Control

SOP For Computer System Control Policy

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Standard Operating Procedure (SOP) for Physical and Logical Control Policy of Computer system to fulfill the requirement of 21CFR Part…

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Posted in: Quality Control Filed under: Computer System Control Policy, Quality Control

HVAC System Qualification Protocol (Validation)

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Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System…

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Posted in: Quality Control Filed under: HVAC System Qualification Protocol, Quality Control

A Complete Guide on HPLC Calibration – Part 3

September 3, 2020 Admin Leave a comment

A Complete Guide on HPLC Calibration – Part 3 (Continued…) In the HPLC Calibration – A complete guide article series,…

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Posted in: Quality Control Filed under: HPLC Calibration, Quality Control

HPLC Calibration- A complete Guide – Part 2

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Continued from …. HPLC Calibration- A Complete Guide Part 1 Part 2 – HPLC Calibration on different Parameter starts from…

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Posted in: Quality Control Filed under: HPLC Calibration, Quality Control

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