Quality Assurance SOP

Control of documentation

Documentation is an essential part of the quality management system. The laboratory should establish and maintain procedures to control and review all documents (both internally generated and from external sources) that form part of the quality documentation. A master list identifying the current version status and distribution of documents should be established and readily available. …

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SOP For Job Responsibility

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Objective : The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Scope : This SOP is applicable to all responsible persons of pharmaceutical Industry …

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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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Temperature And Relative Humidity Monitoring In Pharmaceutical Industry

Temperature and Relative Humidity Monitoring In Pharmaceutical Industry   The environment inside a pharmacy and pharmaceutical storage areas must be optimal and constant to ensure the effectiveness of the medications within them. The implications of humidity for pharmaceutical are numerous as moisture causes de-sterilization, irreversible destabilization and oxidative degradation because the proteins found in many …

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