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Data Processing of Quality Control Lab Equipment. Detailed recommendations are provided in Appendix 5 to Annex 4 of the Fortieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: Supplementary guidelines in good manufacturing practice: validation. Validation of computerized systems (12). For computers, automated tests or calibration equipment, and the collection, processing, recording, …

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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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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   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 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   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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GMP Requirements for Certificates of Analysis (CoA) At times of outsourcing and globalisation, the significance of Certificates of Analysis (CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy and completeness. There are CoAs for excipients, APIs, packaging materials and finished products. A closer look at the guidelines shows that there are …

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General Safety Rules for  Quality Control Laboratory. General Safety Rules For Quality Control Laboratory. General and specific safety instructions reflecting identified risk, should be made available to each staff member and supplemented regularly as appropriate (e.g. with written material, poster displays, audiovisual material and occasional seminars). General rules for safe working in accordance with national …

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Quality Control Testing of Raw Materials, APIs, and Finished Products. The Quality Control Testing  of Raw Materials, APIs, and Finished Products sample should be tested in accordance with the work plan of the laboratory after completion of the preliminary procedures. If this is not feasible the reasons should be noted, e.g. in the analytical worksheet, …

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