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Quality assurance pptx

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Chandrashekhar3
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Quality assurance pptx

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  1. Chhatrapati Shivaji College of Pharmacy Deori Topic name -Facilities and Equipments Class - B pharmacy 3rd year (6th sem) Presented by- Divya J. Tembhurnikar Guided by – Chadrashekhar Badwaik

  2. Facilities: General: The test facility should be located away from manufacturing areas. • Each testing facility shall be of suitable size and construction,location. • Adequate degree of separation of different activities. • Entry of unauthorized person should not be allowed. • Laboratories should be well ventilated and free from dust. •

  3. Animal Facilities: Animal care facilities: Sufficient number of animal room for separation, isolation,quarantine or specialized housing. • Separate area for diagnosis, treatment and control of laboratory animal disease. • Facility for collection and disposal of all animal waste. •

  4. Animal supply facilities: There shall be storage areas as need for feed bedding,supplies and equipment. • Storage areas for feed and bedding shall be separated from areas housing the test system and shall be protected against contamination. • • Facilities for handling test & control articles- In order to prevent contamination must separate areas- Receipt and storage of the test and control articles. • Mixing of the test and control article with a vehicles. • Storage of the test and control articles mixture. •

  5. Laboratory operation areas: Separate laboratories space be provided as needed for the performance of the routine and specialized procedure required by non-clinical laboratory studies. • • Specimens and data storage facilities: Separate space shall be provided for a achieves laminated to access by authorized personnel only for the storage and retrieval of all raw data and specimen from completed studies. •

  6. Equipment: Equipment design - Equipment used in the generation measurement and assessment of data and equipment used for facility environmental control shall be of appropriate design capacity to function according to the protocol and shall be suitable located for operation inspection, cleaning and maintenance. •

  7. Maintenance & Calibration of equipment: The equipment should be properly maintain to ensure constant performance to specification. • Equipment should be adequately inspected,cleaned and maintained. • Equipment used for the generation measurement or assessment of data shall be adequately tested,calibrated and or standardized. • Calibration-The equipment used for the data generation (ex. analytical equipment or balance) • Written records shall be maintained of all inspection maintance testing ,calibrating and or standardizing operation. •

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