1 Quality Management Systems
1 Quality Management Systems
2 Personnel
2 Personnel
3 Premises
3 Premises
4 Facilities and Equipment
4 Facilities and Equipment
5 Pharmaceutical Water
5 Pharmaceutical Water
6 Qualification
6 Qualification
7 Process Validation
7 Process Validation
8 Cleaning Validation
8 Cleaning Validation
9 Computer System Validation
9 Computer System Validation
10 Hygiene
10 Hygiene
11 Production
11 Production
12 Sterile Production
12 Sterile Production
13 Packaging
13 Packaging
14 Laboratory Controls
14 Laboratory Controls
14.A Sampling
14.A Sampling
14.B Substances used in laboratories
14.B Substances used in laboratories
14.C Laboratory Instruments
14.C Laboratory Instruments
14.D Calibration in the lab
14.D Calibration in the lab
14.E Validation of analytical methods
14.E Validation of analytical methods
14.F Stability testing
14.F Stability testing
14.G Test results outside defined criteria (OOX)
14.G Test results outside defined criteria (OOX)
14.H Documentation in the laboratory
14.H Documentation in the laboratory
14.I Batch Release
14.I Batch Release
14.J Microbiological testing
14.J Microbiological testing
14.K Pharmacopoeias
14.K Pharmacopoeias
14.L Laboratory data management systems (LDMS)
14.L Laboratory data management systems (LDMS)
14.M Data integrity in the quality control laboratory
14.M Data integrity in the quality control laboratory
14.M.1 Introduction
14.M.1 Introduction
14.M.2 Taking and handling samples
14.M.2 Taking and handling samples
14.M.3 Sample preparation and preparing for chromatographic determination
14.M.3 Sample preparation and preparing for chromatographic determination
14.M.4 Chromatographic determination
14.M.4 Chromatographic determination
14.M.5 Data evaluation of chromatographic determination and report generation
14.M.5 Data evaluation of chromatographic determination and report generation
14.M.6 Storing and archiving data
14.M.6 Storing and archiving data
14.M.7 Non-compliance with data integrity requirements in analytical laboratories
14.M.7 Non-compliance with data integrity requirements in analytical laboratories
14.M.8 Data integrity during process development and validation
14.M.8 Data integrity during process development and validation
14.M.9 Training and self-inspections
14.M.9 Training and self-inspections
Summary
Summary
14.N Determining and reporting numerical test results in pharmaceutical quality control
14.N Determining and reporting numerical test results in pharmaceutical quality control
14.O Elemental impurities
14.O Elemental impurities
14.P References
14.P References
15 Documentation
15 Documentation
16 Research and Development
16 Research and Development
17 Contractors and Suppliers
17 Contractors and Suppliers
18 Inspections
18 Inspections
19 Quality Risk Management
19 Quality Risk Management
20 Continual Improvement
20 Continual Improvement
21 Active Pharmaceutical Ingredients
21 Active Pharmaceutical Ingredients
22 Excipients
22 Excipients
23 Medical Devices
23 Medical Devices
24 Storage and Transportation
24 Storage and Transportation
as of 2019 - 01 - 24
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14.M Data integrity in the quality control laboratory
14.M.1 Introduction
14.M.2 Taking and handling samples
14.M.3 Sample preparation and preparing for chromatographic determination
14.M.4 Chromatographic determination
14.M.5 Data evaluation of chromatographic determination and report generation
14.M.6 Storing and archiving data
14.M.7 Non-compliance with data integrity requirements in analytical laboratories
14.M.8 Data integrity during process development and validation
14.M.9 Training and self-inspections
Summary
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