What is an Active Pharmaceutical Ingredient?

What is an Active Pharmaceutical Ingredient? “active pharmaceutical ingredient (API) Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological […]

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What is Clinical Trail?

What is a Clinical Trial? Clinical trials are research programs involving people who volunteer to test a new ‘treatment’. Clinical trials aim to find out whether medical, surgical or behavioral interventions work, and if they are safe and effective in management or prevention of disease.The word intervention is a common term used for new or

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List of SOP for Pharmaceutical Quality Assurance

SOP List for Pharmaceutical Quality Assurance. A list of Standard Operating Procedure for Pharmaceutical Quality Assurance Department required During Quality System Management Of Regulatory approved Manufacturing Sites. SOP of SOP SOP For Change control SOP For Handling of incidents and deviations SOP For Training of employees SOP For Self inspection SOP For Risk management SOP

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SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS, AND SUSPENSIONS) Oral Liquids are homogeneous liquid preparations, usually contains a solution, an emulsion or a suspension of one or more active ingredients in a suitable liquid base. They are prepared for oral administration either as such or after dilution. they may contain other substances

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Specific Requirements For Manufacture of Oral Solid Dosage Forms

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES) The processing of dry materials and products creates problems of dust control and cross-contamination. Special attention is, therefore, needed in the design, maintenance and use of premises and equipment in order to overcome these problems. Wherever required, enclosed dust control manufacturing systems shall

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SOP For Corrective Action and Preventive Actions

SOP For Corrective Action and Preventive Actions   OBJECTIVE: Lay down the procedure for corrective and preventive action programme in executing and documenting activities’ for continued compliance and improvement in process as per cGMP. SCOPE: This SOP is applicable to the procedure for Corrective Action and Preventative Actions (CAPA) program at manufacturing facility… RESPONSIBILITY: Officer

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Performance Qualification (PQ) Protocol & Report Format In Pharmaceuticals.

Performance Qualification In Pharmaceutical Industry. Systems and equipment should consistently perform in accordance with design specifications. The performance should be verified in accordance with a performance qualification protocol. There should be documented records for the verification of performance (performance qualification report) to indicate the satisfactory performance over a period of time. Manufacturers should justify the

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Operational Qualification (OQ) Protocol & Report Format In Pharmaceuticals.

Operational Qualification (OQ) In Pharmaceuticals. Systems and equipment should operate correctly and their operation should be verified in accordance with an operational qualification protocol. Critical operating parameters should be identified. Studies on the critical variables should include conditions encompassing upper and lower operating limits and circumstances (also referred to as “worst case conditions”). Operational qualification

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Installation Qualification (IQ) Protocol and Report in Pharmaceuticals  

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals.   Installation Qualification:- Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol. Requirements for calibration, maintenance and cleaning should be drawn up during installation. Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges

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