Quality Control Archives - Page 3 of 7 - Pharmaceutical Guidelines

Acceptable Quality Level (AQL) – SOP and Chart

OBJECTIVE: To define the procedure for Acceptable Quality Level sampling for Tablets and Capsules during bulk approval. SCOPE: This procedure is applicable to bulk approval of manufactured Tablets and Capsules at pharmaceutical product manufacturing location. REFERENCES: ISO 2859-1:1999(en) Sampling procedures for inspection by attributes SOP for Event Reporting and Investigation. DEFINITIONS OF TERMS: […]

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SOP for Polarimeter

SOP

Purpose: The purpose of this SOP is to describe the procedure for operation, cleaning, and calibration of the polarimeter. Scope: This SOP is applicable to the polarimeter available in the Quality control laboratory at the pharmaceutical drug manufacturing plant. Make: … Model:…. Responsibilities – SOP for Polarimeter: The Analyst shall be responsible for: Operate

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

FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated July 23, 2020, to Tender Corporation. The firm manufactures and distributes OTC products. During an inspection from November 12 to 25, 2019, the FDA investigators observed specific violations of current Good Manufacturing Practice (CGMP). The FDA reviewed the response to the Form

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SOP OF GOOD CHROMATOGRAPHY PRACTICES

Quality Control

Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase. The various constituents of the mixture travel at different speeds, causing them to separate. GOOD CHROMATOGRAPHY PRACTICES 1.0 PURPOSE : The

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SOP For FTIR

Quality Control

Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning, and Maintenance of FTIR (Fourier Transform Infrared Spectrometer). Procedure for Operation and Calibration of FTIR 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the start-up, operation, calibration, and maintenance procedure of the FTIR – Fourier Transform Infrared Spectrophotometer. 2.0 SCOPE: This SOP

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SOP For Computer System Control Policy

Quality Control

Standard Operating Procedure (SOP) for Physical and Logical Control Policy of Computer system to fulfill the requirement of 21CFR Part 11 under the cGMP activity in the pharmaceutical drug manufacturing unit. Computer System Control Policy1.0 Purpose: To define the process of the physical and logical security policy of the computer system.2.0 Scope: This applies to

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HVAC System Qualification Protocol (Validation)

Quality Control

Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System Qualification Protocol (Validation) Table of Content – HVAC System Qualification Protocol S.No. Table of Contents Page 1.0 Protocol Approval 2.0 History Sheet 3.0 Objective 4.0 Scope 5.0 Responsibilities 6.0 Equipment Description 6.1 System Specification

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A Complete Guide on HPLC Calibration – Part 3

Quality Control

A Complete Guide on HPLC Calibration – Part 3 (Continued…) In the HPLC Calibration – A complete guide article series, we have discussed about Monthly & Quarterly Calibration parameters, rest of the parameters are described below, in the end of the article all the relevant links has mentioned, in this article there are total 3

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HPLC Calibration- A complete Guide – Part 2

Quality Control

Continued from …. HPLC Calibration- A Complete Guide Part 1 Part 2 – HPLC Calibration on different Parameter starts from Energy check and completed on wavelength accuracy of Detector In the previous article on HPLC Calibration we have covered following parameters. Pressure Test. Drift and Noise Column oven and sample cooler Pump by flow rate

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HPLC Calibration- A Complete Guide Part 1

Quality Control

Calibration of an instrument is the demonstration that the instrument or device produces results within specified limits by comparison with those produced by reference or traceable standard over an appropriate range of measurement. HPLC Calibration is the most critical activity in the laboratory, HPLC is the most sophisticated instrument in the Pharmaceutical Laboratory. This article

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