Wednesday , November 25 2020

SOP

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List of Documents required for Store/warehouse (GMP Compliances)

   

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List of Documents required for Quality Assurance Departments (GMP Compliances)

 

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SOP for Operation, Calibration, and Cleaning of the Conductivity meter

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Operation, Calibration, and Cleaning of the Conductivity meter .2.0 SCOPE:This procedure shall apply to quality control of Pharmaceutical Company for Operation, Calibration, and Cleaning of the Conductivity meter .3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in …

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SOP for Checklist for microbiology data Review.

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Checklist for microbiology data Review .2.0 SCOPE:This procedure shall apply to quality Control(Microbiology lab) of Pharmaceutical Company for microbiology data Review .3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in this SOP. Concerned Department Heads shall be …

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SOP for Checklist for Analytical Raw Data Review (Chemical)

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Checklist for Analytical Raw Data Review (Chemical). 2.0 SCOPE:This procedure shall apply to Quality Ccontrol of Pharmaceutical Company  for Analytical Raw Data Review (Chemical) .3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in this SOP. Concerned Department …

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SOP for Calibration of UV spectrophotometer.

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Calibration of UV spectrophotometer.2.0 SCOPE:This procedure shall apply for Calibration of UV spectrophotometer in quality control departments .3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in this SOP. Concerned Department Heads shall be responsible for compliance of …

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SOP for Operation and Calibration of Total Organic Carbon (TOC)

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Operation and Calibration of Total Organic Carbon (TOC) Analyzer. 2.0 SCOPE:This procedure shall apply for Operation and Calibration of Total Organic Carbon (TOC) Analyzer. .3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in this SOP. Concerned Department …

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SOP for for Calibration of Gas Chromatography (GC)

Objective: To lay down a procedure for Calibration of Gas Chromatography (GC). Scope: This Standard Operating Procedure is applicable for for Calibration of Gas Chromatography (GC). 3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in this SOP. Concerned Department Heads shall be responsible for compliance of the procedure. …

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SOP for Acceptable Quality Level sampling for Tablets and capsule

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Acceptable Quality Level sampling for Tablets and capsule 2.0 SCOPE:This procedure shall apply to formulation plant of Pharmaceutical Company  that manufacture, package, test, and store or distribute drug products. 3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention …

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SOP for the stability of pharmaceutical products

Objective: To lay down a procedure to define the procedure for the stability of pharmaceutical products . Scope: This Standard Operating Procedure is applicable for stability of Pharmaceuticals Product. 2.0 SCOPE:This procedure shall apply to formulation plant of Pharmaceutical Company3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in …

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DGFT guidelines for Barcoding as per GS1 Standards Pharmaceuticals

 

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In-process control of oral drug product during manufacturing & Packing

Objective To lay down the procedure for in-process control of oral drug products during manufacturing & Packing. Scope This procedure is applicable for in-process sampling, analysis and reporting to be carried out during manufacturing and packing of drug products at formulation Plant of Torque Pharmaceutical (P) Ltd., Unit-I, Dappar. Responsibility …

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SAMPLING OF PACKING MATERIALS

OBJECTIVE To lay down a procedure for sampling of packaging materials. SCOPE To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Assurance Manager PROCEDURE …

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PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER

1.0       OBJECTIVE To lay down the procedure for operation and cleaning of unit dose sampler. 2.0     SCOPE This SOP shall be applicable for IPQA area in Quality Assurance.             3.0       RESPONSIBILITY In process Quality Assurance Executive /Officer 4.0       ACCOUNTABILITY Head Quality Assurance 5.0       PROCEDURE FOR OPERATING 5.1       Check the Status …

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Batch Release Statement for Pharmaceutical Product

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Performace Qualification Protocol of Dispensing Booth

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Procedure for Microbiological Monitoring of Purified water

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Inprocess Control of Packing Lines

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Sampling of Intermediates and Finished Products

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Inprocess Control During Tablets Manufacturing

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