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Category: Quality Control

SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath

February 6, 2021 Admin Leave a comment

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of…

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Posted in: Quality Control Filed under: Calibration, Maintenance, Operation, Quality Control SOP, Ultrasonic Water Bath

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 on Operation and Calibration of Melting Point Apparatus

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Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification  of starting materials…

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Posted in: Quality Control Filed under: Melting Point Apparatus, Quality Control SOP

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

SOP For Batch Release of Finished Product

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Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply…

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Posted in: Quality Control Filed under: Batch Release, Quality Assurance

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

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  • SOP List For Pharmaceutical Quality Assurance
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Analyst Qualification Audit Preparation Calibration CAPA Change Management System Cleaning Validation Compression Machine Computerized System EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 laboratory guideline MHRA Microbial Testing Microbiology Microbiology SOP Microbiology Techniques OOS Operation Out of Specification Out of Trend Pharmaceutical Production Pharmaceutical Quality System Phase-I Phase-II Phase Ia Phase Ib production Production SOP QMS Qualifications Protocol Qualification  Steps Quality Assurance Quality Control Quality Control Laboratory Quality Control SOP Quality Management System SOP SOP for Qualification of Quality Control analyst Stability Study Sterile Pharmaceutical products Sterility Testing USFDA
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