Month: April 2019

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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