Annual Product Review (APR) is the requirement of various regulatory agencies. APR roots the monitoring of product quality as well as to find out the scope of quality improvement by controlling the critical process parameters (CPP). APR – Annual Product Review also known as APQR – Annual Product Quality Review and PQR – Product Quality […]
Annual Product Review (APQR / APR / PQR) Read More »
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:
Acceptable Quality Level (AQL) – SOP and Chart Read More »
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
SOP for Polarimeter Read More »
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
SOP on Operation and Calibration of Melting Point Apparatus Read More »
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
SOP for BMR & BPR Review Read More »
Standard Operating Procedure (SOP) for Operation and Cleaning of Metal Detector and Combo Metal Detector cum Deduster used during the manufacturing of drug products in pharmaceuticals. SOP for Metal Detector / Deduster 1.0 PURPOSE: The purpose of this SOP is to describe the cleaning and operation of metal detector and digital combo metal detector cum
SOP for Metal Detector / Deduster Read More »
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
Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter Read More »
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
SOP OF GOOD CHROMATOGRAPHY PRACTICES Read More »
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
SOP For Microbiologist Qualification Read More »
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
SOP for Media Fill Validation Read More »
