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Industrial pharmacy laboratory Lab 1 P Ph.Abbas malik is concerned with the conversion of raw materials into a certain dosage form and in a ______ scale.
large
Industrial pharmacy laboratory includes manufacturing, development, marketing, and distribution of drug products including quality assurance of these ______.
activities
Prepared dosage form should be safe, stable, effective, and ______.
bioavailable
Studying the physicochemical properties of pharmaceutical compounds includes examining chemical structure, solubility, permeability, polymorphism, melting ______, etc.
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The Pharmaceutical research department is concerned with the formulation of the most suitable dosage form, taking into consideration all factors affecting stability, solubility, and mode of action, and convenience of ______.
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Quality Control is focused on defect identification in ______
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Marketing department is responsible for product ______ and marketing
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Return on investment (ROI) is a financial ratio used to calculate the benefit in relation to ______ cost
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Good Manufacturing Practice (GMP) ensures that product is consistently produced and controlled to the quality standards appropriate to their ______ use
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GMP is primarily aimed at reducing the risks inherent in ______ production
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Quality Control and Quality Management practices ensure that the end product or service meets the quality requirements and standards defined for the ______ or service
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Quality control department is responsible for evaluation of dosage forms before going to the market. Perform checking during the entire process of production from raw material to finished products. Following up the product in the market. Quality control vs. quality assurance. Quality Assurance is process oriented and focuses on defect prevention. Quality Assurance is a set of activities for ensuring quality in the processes by which products are developed. Quality assurance is concerned with how a process/product is performed/made. __________ is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
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It includes multiple divisions: chemical research, biological research, pharmacy research, and others. Product development department is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture. This department is responsible for developing formula: try the process on a model of proposed plant before committing large sum of money on a production unit. Evaluation and validation for process and equipment. Confirmation of product uniformity. Scale up requirements: examination of the formula to determine its ability to withstand batch-scale and process modification. __________ department includes all operations which are involved in conversion of raw materials into final product.
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Quality Assurance is process oriented and focuses on defect prevention. Quality Assurance is a set of activities for ensuring quality in the processes by which products are developed. Quality assurance is concerned with how a process/product is performed/made. __________ department is responsible for developing formula: try the process on a model of proposed plant before committing large sum of money on a production unit.
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This department is responsible for developing formula: try the process on a model of proposed plant before committing large sum of money on a production unit. Evaluation and validation for process and equipment. Confirmation of product uniformity. Scale up requirements: examination of the formula to determine its ability to withstand batch-scale and process modification. __________ department is responsible for evaluation of dosage forms before going to the market.
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It includes multiple divisions: chemical research, biological research, pharmacy research, and others. __________ department is responsible for evaluation of dosage forms before going to the market.
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Such risks are essential of two types: cross contamination (in particular of unexpected contaminants) and mix-ups (confusion) caused by, for example, false labels being put on containers GMP PRINCIPLES OF GMP: Principles of GMP Design and construct the facilities and equipment properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits Why GMP Ensure the quality of the medicinal products are consistently produced and controlled according to quality standards.Minimize the risk involved in pharmaceutical production that can't be eliminated through testing the final product.Risk Involved in Pharmaceutical Production 1.Unexpected contamination → damage to health or even death 2.Incorrect labelling on containers → patients receive the wrong medicine 3.Insufficient or too much active ingredients → ineffective treatment or adverse effects Thank you 23
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This department includes all operations which are involved in conversion of raw materials into final product. The department is divided into dosage form based areas, e.g. tablets, capsules, ampoules ….etc. __________ Assurance is process oriented and focuses on defect prevention.
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Such risks are essential of two types: cross contamination (in particular of unexpected contaminants) and mix-ups (confusion) caused by, for example, false labels being put on containers GMP PRINCIPLES OF GMP: Principles of GMP Design and construct the ______ and equipment properly Follow written procedures and Instructions Document work Validate work Monitor ______ and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits Why GMP Ensure the quality of the medicinal products are consistently produced and controlled according to quality standards.Minimize the risk involved in pharmaceutical production that can't be eliminated through testing the final product.Risk Involved in Pharmaceutical Production 1.Unexpected contamination → damage to health or even death 2.Incorrect labelling on containers → patients receive the wrong medicine 3.Insufficient or too much active ingredients → ineffective treatment or adverse effects Thank you 23
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Design and construct the ______ and equipment properly
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Follow written procedures and ______
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Protect against ______
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Control components and product related ______
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Conduct planned and periodic ______
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