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Contents. Introduction. Validation. Calibration. Equipment validation. Equipments.

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Introduction. Validation. Calibration. Equipment validation. Equipments.


Introduction. What is Validation? This section will define validation and will put its meaning in terms pertinent for a technical person. What is Calibration? This section will define calibration and will put its meaning in terms pertinent for a technical person. Food and Drug Administration (FDA) This section will explain the role of the FDA in validation and the guidelines it sets forth. Equipment Validation This section will explain what role unit operations equipment plays in validation and why that is important

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Introduction. Validation. Calibration. Equipment validation. Equipments.

What is Validation?:

What is Validation? According to the Food and Drug Administration (FDA), the goal of validation is to: “ Establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” It is a requirement for Good Manufacturing Practices and other regulatory requirements.

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What does this mean? An quantitative approach is needed to prove quality, functionality, and performance of a pharmaceutical/biotechnological manufacturing process. This approach will be applied to individual pieces of equipment as well as the manufacturing process as a whole. Guidelines for validation are set by the FDA, but the specifications of validation are determined by the pharmaceutical/biotech company.


Types. Cleaning Validation. Process Validation. Analytical Method Validation. Computer System Validation.

Phases of Validation.:

Phases of Validation. Validation is broken down into 5 main phases, Design qualification (DQ ). Installation qualification (IQ ). Operational qualification (OQ ). Performance qualification (PQ ). Component qualification (CQ).

Validation Time Line.:

Validation Time Line. Vendor ’ s Site Owner ’ s site Before Purchase Before Use After Use Structurally Validated Products DQ Functional Validation Installation Operational Performance Qualification Qualification Qualification Maintenance OQ PQ IQ OQ PQ System Suitability During Use

Validation vs. Qualification.:

Validation vs. Qualification. Validation: Refers to the total life cycle of a product from development through use and maintenance. Owners are responsible for Validating Their Processes (personnel, equipment, methods, SOPs) to ensure compliance to cGMP /GLP regulations. Qualification: (Inspection, functional testing and documentation review) Is a part of the validation process which verifies module and system functional performance prior to being placed on-line and thereafter according to a standard operating procedure.

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Introduction. Validation. Calibration. Equipment validation. Equipments.

What is Calibration?:

What is Calibration ? “The operation which assure that an instrument readings are accurate with referenced to established standards”. Laboratory instruments that need to be calibrated are balances, spectrophotometers, pH meters etc. Calibration is performed using primary reference standard.

Need for Calibration?:

Need for Calibration? With a new instrument. When a specified time period is elapsed. When a specified usage (operating hours) has elapsed. When an instrument has had a shock or vibration which potentially may have put it out of calibration. Sudden changes in weather. Whenever observations appear questionable.

Validation vs Calibration:

Validation vs Calibration A calibration is a process that compares a known (the standard) against an unknown (test's device). During the calibration process, the offset between these two devices is quantified and the test's device is adjusted back into tolerance (if possible). A true calibration usually contains both "as found" and "as left" data. A validation is a detailed process of confirming that the instrument is installed correctly, that it is operating effectively, and that it is performing without error. Because a validation must test all three of these operational parameters, it is broken into three different tests: the installation qualification (IQ), the operational qualification (OQ), and the performance qualification (PQ).

Qualification vs Calibration.:

Qualification vs Calibration. QUALIFICATION CALIBRATION Qualification Workbooks(IQ, OQ, PQ) & Project Diskettes Accuracy, Linearity and Precision Tests Appropriate for companies without approved qualification procedures Meets or exceeds US FDA qualification requirements. Calibration Protocols Accuracy Tests Only Appropriate for companies that have approved validation procedures Basic documentation for maintenance and calibration

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Introduction. Validation. Calibration. Equipment validation. Equipments.

Equipment Validation:

Equipment Validation As mentioned earlier, each piece of must be validated in order to legally operate within the facility. The goal is to produce consistent results with minimal variation without compromising the integrity of the product and the persons operating the equipment. A plan of validation should be drafted and executed by engineers in order to satisfy guidelines. The validation plan generally consists of IQ and OQ sections. Any major equipment changes after the initial validation will result in the need for subsequent revalidation. In the end, equipment validation will create specification ranges and tolerances that will be applied to the normal operation of equipment.

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Introduction. Validation. Calibration. Equipment validation. Equipments.


Equipment’s. Validation of different equipments like, Tablet compression machine. Disintegration apparatus. Dissolution apparatus. Friability apparatus. Electronic weighing balance. pH meter. Stability chamber.

Tablet compression machine.:

Tablet compression machine. OTHER SPECIFICATIONS FOR ALL MODELS Punch Dia. 19 mm (3/4") Punch Length 133.65 mm (5.262") Operating Force 6.5 Tons Max . Depth of Fill 17.4 mm Electric Motor 3 HP/ 1440 RPM 440 V/ 50CS/ 3PH. AC

Tablet compression machine.:

Tablet compression machine. PACKAGING SPECIFICATIONS Particulars Unit STD GMP Machine Dimension Inch L x W x H 39 x 39 x 70 L x W x H 39 x 39 x 70 Case Dimension Inch L x W x H 50 x 53 x 72 L x W x H 57 x 54 x 83 Net Weight Kg . 1200 1425 Gross Weight Kg . 3.5 4.5 Case Volume M3 3.5 4.5

Disintegration Apparatus:

Disintegration Apparatus Model 901 System Digital Tablet Disintegration Apparatus Up and Down Speed 30 rpm ± 2 rpm Accuracy 2% Resolution 1 sec. Operating Temp. Range 0 - 100°C Power 230V ± 10%, 50Hz.AC Dimensions 450 mm (H) X 300 mm (W) X 320 mm (L) (Approx.) Weight 8 Kgs . (Approx.)

Dissolution Apparatus.:

Dissolution Apparatus. GENERAL Stations 8 Stations in Model - 1918 6 Stations in Model - 1916 Display 20 x 4 Line Alphanumeric LCD display with Backlit Keyboard 19 soft touch membrane keys LED' 6 LED's, 3 LED's for Test status like Run, Alarm, End and 2 LED's for Platform up/down status and one for heater ON/OFF status. Prog. Mode Routine, Sustain and Control mode. Facility for 20 different test setups available in Routine and Sustain mode. Printer Provision for the attachment of dot-matrix printer with centronics parallel port interface available. STIRRER Speed 25 - 200 RPM, + 1 RPM Resolution 1 RPM Accuracy + 1 RPM

Dissolution Apparatus.:

Dissolution Apparatus. TEMPERATURE Range 30 - 50 o C Accuracy + 1 o C Temp. Control Microprocessor Based using PT100/Semiconductor Sensor SAMPLING Reaction Vessel 1000 ml jars with stirrer pedals and baskets Heater 1 KW Power 230 V ± 10%, 50 Hz. AC Accessories Main Unit with Acrylic Tank and Rectangular Cover Plate and Water Bath Temperature Sensor (T1) External Temperature Sensor (T2) for Vessel Reaction Vessel capacity 1000 ml (8 Nos. in Model - 1918 and  (6 + 1) Nos. in Model - 1916) Round Acrylic Cover Plate with Hole and a large slit (8 Nos. in Model - 1918 & 6 Nos. in Model - 1916) S.S. Paddle, S.S Wire Mesh Basket (8 Nos. in Model - 1918 & 6 Nos. in Model - 1916) Glass pipettes with rubber bellows Mains Lead Instruction Manual Dust Cover

Friability Apparatus.:

Friability Apparatus. Display 3 digit bright red seven segment LED display Accuracy ± 1 revolution Resolution 1 revolution Range 0-999 revolutions No. of drums 1-2. Operating Temp. Range 10º-50º C Power 230 V ± 10%, 50 Hz. AC Dimension 230 mm (H) X 250 mm (W) X 540 mm (L) (Approx.) Weight 9.5 Kg. (Approx Accessories Drum 1 No. (902), 2 Nos. (903), Dust Cover-1 No.

Electronic weighing balance.:

Electronic weighing balance. WEIGHING CAPACITY 42/210 gm READIBILITY 0.00001gm/0.0001 gm REPEATABILITY 0.00002/0.0001 gm LINERITY ± 0.00003/0.0002 gm STABILISATION TIME 3.5/8 Sec TARING RANGE SUBSTRACTIVE 210 gm CALIBRATION Internal OPERATING TEMPERATURE RANGE 5˚ C to 40˚ C, 85% RH or less WEIGHING UNIT pcs , gm , mg, oz. INTERFACE Bi-Directional RS 232C with software gfin CD

pH Meter.:

pH Meter. Range 0.00 to 14.00 pH, 0.0 to 100°C Resolution 0.01 pH, 0.1°C Accuracy +/- 0.01pH, +/-0.5°C Calibration Up to 3 points, offset 0.1°C pH Slope Range 80% to 120% Auto Buffer Recognition pH 4.01, 7.00, 10.00 Auto Shutoff after 17 minutes Automatic Temperature Controller 0.0 to 50°C Operating Temperature 0 to 50°C Keys ON/OFF, HOLD/ENTER Probe Combination gel-filled epoxy body, Ag/ AgCl . Power 4 AAA Alkaline Batteries Size 5.5" X 2.7" X 1.3" (14 X 7 X 3.5 cm)

Stability chamber.:

Stability chamber. Workspace Volume 24 cu. ft. (680 L) 33 cu. ft. (935 L) 52 cu. ft. (1475 L) 80 cu. ft. (2265 L) Internal Dimensions W x D x H Inches (cm) 23.5 x 30 x 59 (60 x 76 x 150) 27.75 x 31 x 67 (71 x 79 x 170) 51 x 30 x 59 (130 x 76 x 150) 78.5 x 30 x 59 (200 x 76 x 150) External Dimensions W x D x H Inches (cm) 27.5 x 30 x 80.4 (70 x 76 x 204) 31.8 x 35.9 x 88.4 (81 x 91 x 225) 55 x 34.9 x 80.4 (140 x 89 x 204) 82.5 x 34.9 x 80.4 (210 x 89 x 204) Long Term Intermediate Accelerated 25°C/60% RH or 30°C/60% RH 30°C/65% RH 40°C/75% RH

Stability chamber.:

Stability chamber. Temperature Range Temperature Units 4°C to 70°C (39°F to 158°F) Temp/Humidity Units 5°C to 60°C (41°F to 140°F) Optional Humidity Range 25% to 95% RH Tolerance Temperature +/- 1°C @ 4°C to 70°C (39°F to 158°F) Humidity +/- 5% @ 5°C to 60°C (41°F to 140°F) Temperature Uniformity +/- 1°C @ 4°C to 70°C (39°F to 158°F)

Stability chamber.:

Stability chamber. No. of Shelves 3 3 6 9 Total Amp Draw 208-230V, 60Hz. 11.7 11.7 13.4 18.8 230V, 50Hz. 11.3 11.3 - - Maximum Fuse 15.0 15.0 20.0 30.0


Reference’s Pharmaceutical process validation by Robert Nash, Alfred H Wachter .

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