2020

SOP on Operation and Calibration of Melting Point Apparatus

Quality Control

Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification  of starting materials (Raw Material – API & Excipient) in Quality Control Laboratory. Operation and Calibration of Melting Point Apparatus 1.0   PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration and maintenance of […]

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SOP for BMR & BPR Review

Quality Assurance

Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing plant. A detailed checklist for review of BMR and BPR for Draft Copy as well as  Filled Copy of Batch Manufacturing/Packing Records.  Procedure for BMR & BPR Review 1.0       PURPOSE: The purpose of

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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 For Microbiologist Qualification

Microbiology

Standard Operating Procedure (SOP) and Protocol for Microbiologist Qualification (validation) to establish and assure that Microbiologist is capable of performing Microbiological testing in Microbiology Department. Microbiologist Qualification 1.0   PURPOSE : The purpose of this Standard Operating Procedure (SOP) is to lay down the Procedure for Microbiologist Qualification (validation) to establish and assure that Microbiologist is

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SOP for Media Fill Validation

Microbiology

Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility.  A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. The microbiological growth medium is used in place of the drug solution during media fills

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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 Sampling and Testing of Purified Water in Microbiology

Microbiology

Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Sampling and Testing of Purified Water in Microbiology 1.0   PURPOSE: To lay down the procedure for Sampling and Testing of Purified Water. 2.0   SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department. 3.0   REFERENCE:

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