ChemTechStandards

A. Procure and prepare samples and standards for testing 2

B. Analyze samples using qualitative and quantitative methods 5

C. Perform instrumental analysis 9

D. Maintain a safe pharmaceutical laboratory working environment 16

E. Maintain equipment and laboratory inventories 18

F. Maintain and monitor regulatory compliance 20

G. Maintain technical information 22

H. Analyze solid and liquid samples of oral medications using specific dosage form tests 23

1. Procure and prepare samples and standards for testing

1. Collect samples and standards
1. Reference standards are stored to avoid degradation according to company SOP.
2. Sampling schemes are designed to ensure adequate representation of bulk material according to company SOP.
3. Representative samples of solid materials in bulk storage are obtained according to company SOP.
4. Representative samples of high-vapor-pressure materials are obtained according to company SOP.
5. Representative samples of corrosive liquids are obtained according to company SOP.
6. Representative samples of materials in open environmental systems are obtained according to company SOP.
7. Representative samples of non-homogeneous solids are obtained according to company SOP.
8. Representative samples of air-sensitive materials are obtained according to company SOP.
9. Representative samples of moisture-sensitive materials are obtained according to company SOP.
10. Representative samples of light-sensitive materials are obtained according to company SOP.
11. Representative samples of temperature-sensitive materials are obtained according to company SOP.
12. Representative samples of gases under pressure are obtained according to company SOP.
13. Representative samples of microscale quantities of liquids and solids are obtained according to company SOP.
14. Representative samples of biological specimens are obtained according to company SOP.
15. Liquids, solids, and gases are transferred from bulk containers to lab sample containers according to safety and end use requirements.

2. Prepare samples in required form
1. Liquids, solids, and gases are transferred from bulk containers to labware according to safety and end use requirements.
2. Acids and bases are identified and handled according to company SOP.
3. Samples of chemicals classified as carcinogens or suspected carcinogens are identified and handled according to company SOP.
4. Samples of chemicals classified as teratogens or suspected teratogens are identified and handled according to company SOP.
5. Techniques used for sampling are determined according to company SOP.
6. Samples are prepared for analysis by dissolving in aqueous or non-aqueous solvents according to dissolution requirements.
7. Samples are treated using acid digestion, ashing, or reflux according to analysis requirements.
8. Samples are prepared for analysis using a mortar and pestle, ball mill grinder, or hammer mill grinder according to company SOP.
9. Sieves are used to separate samples based on particle size according to company SOP.
10. Reports outlining sample preparation techniques, types of materials, and analytical methods are presented according to company SOP.

3. Prepare samples for chromatographic analysis, including high performance liquid chromatographic (HPLC) analysis
1. Chromatographic samples are prepared for assay and impurity determination, ensuring proper storage, pre-treatment, weighing, volumetric dilution, particulate removal, sample extraction, protection from light and sample derivatization, according to company SOP.
2. Chromatographic techniques are selected based on the characteristics of the material to be separated according to company SOP.
3. Column chromatography is used to isolate components and prepare samples for analysis according to company SOP.

4. Prepare analytical solutions
1. Mole quantities and equivalent quantities of chemicals are calculated.
2. Solution concentrations, including molarity, normality, and molality, are calculated.
3. Mass requirements for solutions of known concentration are calculated from compound molecular weight.
4. Solutions of known concentration are used to prepare diluted solutions.
5. Solute gram, milligram, and microgram weight quantities are calculated for solution preparation at a specified normality.
6. Equivalent weights of acids and bases in a given reaction are calculated according to their formula weight.
7. Equivalent weights of oxidizing agents and reducing agents are calculated for given oxidation-reduction reactions.
8. Solutions of mass/volume percent, volume/volume percent, normality, molarity, and ppm concentrations are prepared for use in acid-base and oxidation-reduction titrations.
9. Samples are prepared for analysis, such as assay and impurity determination, via filtration techniques according to company SOP.
10. Samples are prepared for analysis, such as assay and impurity determination, via distillation techniques according to company SOP.
11. Samples are prepared for analysis, such as assay and impurity determination, via evaporation techniques according to company SOP.
12. Samples are prepared for analysis, such as assay and impurity determination, via extraction techniques according to company SOP.
13. Samples are prepared for analysis, such as assay and impurity determination, via crystallization techniques according to company SOP.
14. Samples are prepared for analysis, such as assay and impurity determination, via electrophoresis according to company SOP.

5. Prepare test samples for compendial analysis
1. Samples are prepared for instrumental analysis according to company SOP.
2. Grades of chemical reagents, including the specific characteristics required of spectral grade and/or chromatographic reagents, are identified to meet analysis requirements according to company SOP.
3. Samples are protected from contamination or alteration according to company SOP.
4. Hygroscopic and moisture sensitive materials are handled according to company SOP.
5. Materials are extracted from a variety of matrices using liquid-liquid and solid-liquid techniques according to company SOP.
6. Specified quantities of materials are manipulated according to company SOP.

6. Separate/ extract chemical materials
1. Liquid-liquid extractions are conducted per analytical and analysis requirements according to company SOP.
2. Solid-phase extractions are conducted per analytical and analysis requirements according to company SOP.
3. Solid-phase micro-extractions are conducted per analytical and analysis requirements according to company SOP.
4. Soxhlet extractions are conducted per analytical and analysis requirements according to company SOP.
5. Supercritical fluid extractions are conducted per analytical and analysis requirements according to company SOP.
6. Extracts are diluted per analytical and analysis requirements according to company SOP.
7. Extracts are distilled per analytical and analysis requirements according to company SOP.

2. Analyze samples using qualitative and quantitative methods

1. Develop standard analytical laboratory methods
1. Methods for developing product specifications follow USP National Formulary (NF), American Society for Testing and Materials (ASTM), Association of Analytical Communities (AOAC), Environmental Protection Agency (EPA), and International Union for Pure and Applied Chemistry (IUPAC) guidelines and company SOP.
2. Analytical procedures are identified for obtaining selected data based on the property to be measured, material to be analyzed, product specification, sample size, sample type, required accuracy/precision, selectivity, and sensitivity according to company SOP.
3. Newly developed analytical methods are validated according to company SOP.
4. All analytical methods and method validations are documented according to company SOP.

2. Apply standard laboratory techniques and calculations
1. The standard rules to determine the number of significant figures in measurements are applied.
2. English system values are converted to metric equivalents when measuring mass and volume.
3. Means, medians, modes, and standard deviations are calculated for data sets.
4. Volumetric glassware is used according to company SOP.
5. Mass quantities from 1 mg to 1,000 grams are measured to specified accuracy and precision according to company SOP.
6. Volumetric glassware, thermometers, lab-scale storage containers, vacuum ovens, and timers are calibrated according to recognized industry standards and company SOP.
7. Safety testing equipment and air- and water-monitoring equipment are calibrated according to recognized industry standards and company SOP.
8. Analog scales, such as those on laboratory glassware, charts, graphs, thermometers and spectra, are read according to company SOP.
9. Analytical balances are selected for weighing samples to assure balance accuracy and precision according to company SOP.
10. Volume, temperature, and pressure for gases are calculated according to the Ideal Gas Law, Charles’ Law, and Boyle’s Law.

3. Measure physical properties of laboratory samples
1. Sample color is determined according to company SOP.
2. Sample solubility is determined according to company SOP.
3. Sample fill volume is determined according to company SOP.
4. Sample density is determined according to company SOP.
5. Sample particle size is determined according to company SOP.
6. Sample weight is determined according to company SOP.
7. Sample specific gravity is determined according to company SOP.
8. Sample melting point is determined according to company SOP.
9. Sample appearance is characterized according to company SOP.
10. Sample molecular weight is determined according to company SOP.
11. Sample viscosity is determined according to company SOP.
12. Sample dew point is determined according to company SOP.
13. Humidity and relative humidity are determined according to company SOP.
14. The flash points of liquid samples are determined according to company SOP.
15. The cloud points of liquid samples are determined according to company SOP.
16. Sample thermal conductivity is determined according to company SOP.
17. Sample heat capacity is determined according to company SOP.
18. The specific rotations of chiral materials are determined according to company SOP.
19. Sample refractive indices are determined according to company SOP.
20. Sample electrical conductivity is determined according to company SOP.
21. Sample total organic carbon (TOC) is determined according to company SOP.
22. Process water, purified water, and/or water for injection are characterized according to company SOP.

4. Conduct pH and/or conductivity measurements of laboratory samples
1. The pH scale (acidity/basicity) is used according to recognized industry methods.
2. pH is calculated from hydronium ion or hydroxide ion concentrations.
3. pH meters are calibrated according to company SOP.
4. Indicators, papers, and pH meters are used to measure pH according to company SOP.
5. Buffer solutions are prepared to control the pH of solutions according to company SOP.
6. pH is measured using in-line pH meters according to company SOP.
7. Conductivity meters are calibrated according to company SOP.
8. Sample conductivity is measured using in-line conductivity meters according to company SOP.

5. Conduct spectroscopic analysis of laboratory samples
1. Colorimeters and spectrophotometers are used in the analysis of heavy metals, arsenic, lead, and iron according to company SOP.
2. Absorbance, path length, and extinction coefficients are applied using Beers’ Law to accurately measure solution concentrations.
3. Standards are used for calibration in spectroscopic analysis according to company SOP.
4. Absorbance/transmittance conversions are performed according to company SOP.
5. The working ranges for spectroscopic measurements are determined.
6. The detection limits for specific spectroscopic analysis are determined.
7. Wavelength, frequency, and color for the visible light spectrum are used in chemical measurements according to company SOP.
8. Cells for gases and liquids are selected, used, and cared for according to company SOP.
9. Sample turbidity and/or fluorescence is tested using nephlometers.
10. Sample turbidity and/or fluorescence is tested using fluorometers.

6. Conduct volumetric analysis of laboratory samples
1. Equivalent weights of selected bases used for acid neutralization are calculated.
2. Solutions of unknown concentration are standardized for use as titrants in designated reactions.
3. Titrations in aqueous media are conducted using designated electrodes according to analytical or experimental requirements.
4. Electrode potential curves from a titration data set are plotted.
5. Electrodes are maintained according to vendor guidelines.
6. Titrations in non-aqueous media are conducted according to analytical or experimental requirements.
7. Concentrations are determined using acid-base titrations.
8. Concentrations are determined using oxidation-reduction titrations.
9. Concentrations are determined using compleximetric titrations.

7. Conduct gravimetric analysis of laboratory samples
1. Samples are filtered based upon experimental and analytical requirements according to company SOP.
2. Samples are prepared for weight determination based upon experimental and analytical requirements according to company SOP.
3. Sample weights are determined by experimental and analytical requirements according to company SOP.
4. Nonvolatile inorganic material contents are calculated using residue on ignition (ROI).

8. Conduct solids analysis of laboratory samples
1. Sample surface areas are determined according to company SOP.
2. Moisture analyses are conducted according to company SOP.
3. Thermal analyses are conducted according to company SOP.

9. Conduct endotoxin analysis of laboratory samples
1. Microbiological analyses, such as Limulus Amebocyte Lysate analysis, are conducted using gel clot techniques according to company SOP.
2. Microbiological analyses, such as Limulus Amebocyte Lysate analysis, are conducted using photometric techniques according to company SOP.
3. Sample sterility is tested according to company SOP.

10. Conduct microscale analysis of laboratory samples
1. Microscale analyses of physical properties are conducted on selected samples according to company SOP.
2. Microscale pH and/or conductivity analyses are conducted on selected samples according to company SOP.
3. Microscale colorimetric analyses are conducted on selected samples according to company SOP.
4. Microscale fluorometric analyses are conducted on selected samples according to company SOP.
5. Microscale volumetric analyses are conducted on selected samples according to company SOP.
6. Microscale gravimetric analyses are conducted on selected samples according to company SOP.
7. Microscale solids analyses are conducted on selected samples according to company SOP.
8. Microscale endotoxin analyses are conducted on selected samples according to company SOP.

11. Analyze laboratory samples using thin layer chromatography (TLC)
1. Safety guidelines and federal regulations associated with using TLC are followed.
2. TLC methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. TLC capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in TLC data are identified.
5. TLC analyses of known mixtures are conducted according to company SOP.
6. The components in unknown materials are identified using TLC.
7. Sample separation is enhanced by adjusting parameters such as temperature, solvent polarity, and stationary phases.
8. Reagents are used to visualize the sample components being separated by TLC.

12. Report analytical results
1. Precision and accuracy for data sets are calculated according to company SOP.
2. Standard deviations are calculated at one, two, and three sigma.
3. Control charts that describe the upper and lower control limits are prepared.
4. Out-of-specification (OOS) results are handled according to company SOP.
5. Out-of-expectation (OOE) results are handled according to company SOP.

3. Perform instrumental analysis

1. Analyze laboratory samples using high performance liquid chromatography (HPLC)
1. Safety guidelines and federal regulations associated with high performance liquid chromatographs are followed according to company SOP.
2. Qualitative HPLC methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Quantitative HPLC methods are used with accuracy and reproducibility to analyze samples according to company SOP.
4. High performance liquid chromatograph capabilities are matched to corresponding analysis requirements.
5. Potential sources of error in HPLC data are identified.
6. High performance liquid chromatographs are calibrated and maintained according to company SOP.
7. System suitability parameters, such as LOQ, LOD, and relative standard deviation, are calculated according to company SOP.
8. HPLC methods are validated according to company SOP.
9. High-purity solvents for HPLC analyses are selected according to company SOP.
10. HPLC mobile phases of appropriate polarity for various separation needs are prepared and degassed according to company SOP.
11. Operational parameters, such as flow rate, temperature, pressure, and choice of detector, are established for HPLC analyses according to company SOP.
12. Gradient programs are established to enhance HPLC separation according to company SOP.
13. Pump configurations are chosen for desired isocratic and gradient capabilities according to company SOP.
14. Appropriate corrections and calibrations for HPLC analyses are made according to company SOP.
15. The separation performances of high performance liquid chromatographs are enhanced by adjusting parameters to optimize peak width and resolution and minimize tailing in the chromatogram.
16. The integration process is employed for calculating chromatographic peak areas according to company SOP.
17. A variety of high performance liquid chromatographs, including computer controlled and automated, are used to analyze known and unknown mixtures according to company SOP.
18. A variety of HPLC columns are used to analyze known and unknown mixtures according to company SOP.
19. Bonded phase chromatography, gel permeation chromatography, and gel filtration are applied according to company SOP.

2. Analyze laboratory samples using ultraviolet (UV)-visible spectroscopy
1. Safety guidelines and federal regulations associated with using UV-visible spectrophotometers are followed.
2. UV-visible spectrophotometric methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. UV-visible spectrophotometer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in UV-visible spectrophotometric analytical data and results are identified.
5. Spectrophotometric cells are cared for according to company SOP.
6. Sample concentrations are calculated from sample absorbance, path length, and extinction coefficients using Beers’ Law.
7. UV-visible spectrometers are calibrated using standards according to company SOP.
8. The lower and upper UV-visible detections limits for specific analytes are determined.
9. Operational parameters, such as wavelength range, scan rate, and temperature, are established according to company SOP.
10. Analytes are detected using appropriate UV-visible detectors as determined by analysis requirements.

3. Analyze laboratory samples using gas chromatography (GC)
1. Safety guidelines and federal regulations associated with using gas chromatographs are followed.
2. Qualitative GC methods are conducted with accuracy and reproducibility to analyze samples according to company SOP.
3. Quantitative GC methods are conducted with accuracy and reproducibility to analyze samples according to company SOP.
4. Gas chromatograph capabilities are matched to corresponding analysis requirements.
5. Potential sources of error in GC analytical data and results are identified.
6. GC gas flow rates are used according to separation requirements.
7. GC separation is enhanced using gradient programs according to company SOP.
8. A variety of chromatographic columns, including packed and capillary glass, are used for the separation and characterization of a known mixture according to company SOP.
9. A variety of polar and non-polar stationary phases are used for the separation and characterization of a known mixture according to company SOP.
10. Operational parameters, such as gas flow rate and temperature, are established according to company SOP.
11. Different types of gas chromatographs, including computer controlled and automated, are used to analyze known and unknown mixtures according to company SOP.
12. Sample organic volatile impurities are quantified according to company SOP.
13. System suitability requirements are identified according to company SOP.
14. GC methods are validated according to company SOP.

4. Analyze laboratory samples using X-ray fluorescence
1. Safety guidelines and federal regulations associated with using X-ray fluorimeters are followed.
2. X-ray fluorescence methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. X-ray fluorimeter capabilities, including its non-destructive nature, are matched to corresponding analysis requirements.
4. Potential sources of error in X-ray fluorimetric data are identified.
5. X-ray fluorescence analyses of known samples are conducted, involving instrument calibration, matrix correction, sample preparation, and calculation of percent of component element, according to company SOP.
6. X-ray fluorescence analyses of unknown samples are conducted according to company SOP.
7. Analyte concentrations are calculated from X-ray intensity and wavelength using the Bragg equation.

5. Analyze laboratory samples using atomic emission (AE) spectroscopy
1. Safety guidelines and federal regulations associated with using AE spectrometers are followed.
2. AE spectrometric methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. AE spectrometer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in AE spectrometric data are identified.
5. Liquid samples are prepared for AE analysis according to company SOP.
6. A variety of energy sources are used to excite AE samples.
7. Analytes are detected using appropriate AE detectors as determined by analysis requirements.

6. Analyze laboratory samples using atomic absorption (AA) spectroscopy
1. Safety guidelines and federal regulations associated with using AA spectrometers are followed.
2. AA spectrometric methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. AA spectrometer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in AA spectrometric data are identified.
5. Samples are prepared for AA analysis according to company SOP.
6. AA spectrometers are calibrated according to company SOP.
7. Corrections are made for chemical interference.
8. Appropriate AA energy sources are used as determined by analysis requirements.

7. Analyze laboratory samples using X-ray diffraction
1. Safety guidelines and federal regulations associated with using X-ray diffractometers are followed.
2. X-ray diffraction methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. X-ray diffractometer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in X-ray diffraction data are identified.
5. X-ray diffraction patterns are used to determine crystal structure according to company SOP.
6. Structures are determined via single-crystal X-ray analysis.
7. The Bragg equation is used to calculate inter-planar spacing.

8. Analyze laboratory samples using infrared (IR) spectroscopy
1. Safety guidelines and federal regulations associated with using IR spectrometers are followed.
2. IR spectroscopic methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. IR spectrophotometer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in IR spectrometric data and results are identified.
5. IR cells are cared for according to vendor guidelines.
6. IR samples are prepared in various forms, such as mulls, pellets, reflectants, salt plates, and liquid sample cells, appropriate for the sample form and state of matter.
7. Appropriate IR detectors are used as determined by analysis requirements.
8. Common mechanisms of interfacing IR spectrometers with other instruments are employed in the laboratory according to company SOP.
9. Computerized references are compared to sample spectra in order to identify the sample.
10. IR spectroscopy is used to identify organic functional groups in a given sample.

9. Analyze laboratory samples using near-infrared (near-IR) spectroscopy
1. Safety guidelines and federal regulations associated with using near-IR spectrometers are followed.
2. Near-IR spectroscopic methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Near IR spectrophotometer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in near-IR spectrometric data and results are identified.
5. Near-IR cells are cared for according to vendor guidelines.
6. Near-IR samples are prepared in various forms, such as mulls, pellets, reflectants, salt plates, and liquid sample cells, appropriate for the sample form and state of matter.
7. Appropriate near-IR detectors are used as determined by analysis requirements.
8. Common mechanisms of interfacing near-IR spectrometers with other instruments are employed in the laboratory according to company SOP.
9. Near-IR spectroscopy is used to identify functional groups in a given sample.
10. Computerized references are compared to sample spectra in order to identify the sample.

10. Analyze laboratory samples using mass spectrometry (MS)
1. Safety guidelines and federal regulations associated with using mass spectrometers are followed.
2. MS methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Mass spectrometer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in MS data are identified.
5. Samples are prepared for MS analysis according to analysis requirements and company SOP.
6. Parent ion and molecular fragment ion peaks in mass spectra of samples are identified and compared to those in reference spectra.

11. Analyze laboratory samples using electro-analytical techniques
1. Safety guidelines and federal regulations associated with electro-analytical instrumentation are followed.
2. Electro-analytical methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Electro-analytical instrumentation capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in electro-analytical data are identified.
5. Ion-selective electrodes are used for measurement of cations or anions according to company SOP.
6. Karl Fischer analyses are performed to determine the water content of samples according to company SOP.
7. Electro-analytical analyses of samples are conducted using polarography according to company SOP .
8. Electro-analytical analyses of samples are conducted using coulometry according to company SOP.
9. Electro-analytical analyses of samples are conducted using electroplating according to company SOP.
10. The stoichiometric number of electrons involved in oxidation and reduction half reactions are determined.
11. Analyte concentrations are calculated using Faraday’s Law.

12. Analyze laboratory samples using nuclear magnetic resonance (NMR) spectroscopy
1. Safety guidelines and federal regulations associated with using Fourier transform nuclear magnetic resonance (FT-NMR) spectrometers are followed.
2. FT-NMR spectrometric methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. FT-NMR spectrometer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in FT-NMR spectroscopic data are identified.
5. Liquid samples are prepared for FT-NMR analysis according to company SOP.
6. FT-NMR spectrometers and magnets are tuned and calibrated according to vendor specifications.
7. NMR analyses of known samples are conducted using proton and C-13 methods according to company SOP.
8. Two-dimensional (2D) NMR analyses of unknown samples are conducted using proton-proton coupled and proton-carbon coupled methods according to company SOP.
9. The NMR spectra features of chemical shift and multiplicity are used to elucidate the chemical structure of a pure sample.
10. Appropriate deuterated solvents are chosen for samples based on sample solubility according to company SOP.
11. Appropriate deuterated solvents are chosen for samples based on temperature requirements of the experiment according to company SOP.

13. Analyze laboratory samples using polarimetry
1. Safety guidelines and federal regulations associated with using polarimeters are followed.
2. Polarimetric methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Polarimeter capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in polarimetric data are identified.

14. Analyze laboratory samples using capillary electrophoresis (CE)
1. Safety guidelines and federal regulations associated with using CE instrumentation are followed.
2. CE methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. CE instrumentation capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in CE data are identified.
5. The preparation of CE columns is described according to company SOP.
6. CE instruments are calibrated according to company SOP.

15. Analyze laboratory samples using light microscopy
1. Safety guidelines and federal regulations associated with using light microscopes are followed.
2. Light microscopy methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Light microscope capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in light microscopy data are identified.
5. Observations regarding homogeneity, heterogeneity, size, color, and other physical characteristics are made using light microscopy.
6. A variety of potential crystal types are identified according to company SOP.
7. Immersion aids with specified refractive indices are used according to company SOP.

16. Analyze laboratory samples using scanning electron microscopy (SEM)
1. Safety guidelines and federal regulations associated with using scanning electron microscopes are followed.
2. SEM is used with accuracy and reproducibility to analyze samples according to company SOP.
3. Scanning electron microscope capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in SEM data are identified.
5. Observations regarding homogeneity, heterogeneity, size, color, and other physical characteristics are made using SEM.
6. A variety of potential crystal types are identified according to company SOP.

17. Analyze laboratory samples using transmission electron microscopy (TEM) or/and scanning transmission electron microscopy (STEM)
1. Safety guidelines and federal regulations associated with using transmission electron microscopes are followed.
2. TEM and/or STEM methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Transmission electron microscope capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in TEM and STEM data are identified.
5. Observations regarding homogeneity, heterogeneity, size, color, and other physical characteristics are made using TEM and/or STEM.
6. A variety of potential crystal types are identified according to company SOP.
7. The Bragg equation is used to calculate inter-planar spacing.

18. Analyze laboratory samples using light scattering
1. Safety guidelines and federal regulations associated with light scattering instrumentation are followed.
2. Light scattering methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Light scattering instrumentation capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in light scattering data are identified.
5. Representative samples are prepared for light scattering analysis according to company SOP.

19. Conduct thermogravimetric analysis (TGA) of laboratory samples
1. Safety guidelines and federal regulations associated with using thermogravimetric analyzers are followed.
2. TGA methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Thermogravimetric analyzer capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in TGA data are identified.
5. Representative samples are prepared for TGA according to company SOP.

20. Conduct humidity and relative humidity analysis of laboratory samples
1. Safety guidelines and federal regulations associated with using humidity analysis instrumentation are followed.
2. Vapor sorption/desorption methods are used with accuracy and reproducibility to analyze samples according to company SOP.
3. Chambers of various humidity conditions are set up as required by the analytical method according to company SOP.
4. Vapor sorption/desorption analysis capabilities are matched to corresponding analysis requirements.
5. Potential sources of error in vapor sorption/desorption data are identified.

4. Maintain a safe pharmaceutical laboratory working environment

1. Acquire safety and company SOP training
1. OSHA training meetings are attended periodically according to company policy.
2. Incident reports, emergency responses and evacuation plans are reviewed.
3. Company SOP training is attended according to company requirements.
4. Safety, company SOP and OSHA-related training is documented according to company SOP.

2. Inspect personal protective equipment (PPE)
1. Laboratory spill kits are assessed for completeness and currency according to company SOP.
2. Chemical hygiene policies are reviewed according to company SOP.
3. Chemical hygiene policies are practiced according to company SOP.
4. Alarms and emergency communications systems are tested according to company SOP.
5. Safety showers, eye wash stations, fume hoods, emergency exits, and fire protection devices are routinely assessed according to company SOP.
6. Evacuation, fire and safety drills are practiced according to company SOP.
7. Laboratory protective clothing, such as lab coats and aprons, is worn in the laboratory when handling chemicals according to company SOP.
8. Protective eyewear is worn in the laboratory at all times according to company SOP.
9. Protective footwear, such as non-conductive shoes and steel toe shoes, is worn in the laboratory according to company SOP.
10. Protective earwear is worn according to company SOP.
11. Protective gloves are worn during chemical handling at all times according to company SOP.
12. Protective gloves are worn during handling items at extreme temperatures according to company SOP.
13. A respirator is worn in the laboratory, as needed, according to company SOP.
14. PPE training is attended according to company SOP.

3. Store materials and chemicals
1. Chemicals are inventoried according to company SOP.
2. Reference literature, including company SOPs, MSDSs, and the Handbook of Chemistry and Physics, are used to identify hazards associated with storing chemical materials according to company SOP.
3. Chemical and chemical solutions are labeled according to company SOP.
4. Gas cylinders are secured according to company SOP.

4. Handle chemical materials
1. Solvents, detergents, and brushes are used to clean glassware and laboratory equipment according to company SOP.
2. Reference literature, including company SOPs, MSDSs, and the Handbook of Chemistry and Physics, is used to identify hazards associated with handling chemical materials.
3. Hazardous materials, including corrosives, are handled according to regulatory guidelines (EPA, OSHA) and company SOP.
4. Techniques for mixing acids and bases are used according to company SOP.
5. Techniques for mixing strong oxidizing and reducing agents are used according to company SOP.
6. Volatile chemicals are safely handled according to company SOP.
7. Gases, liquids, and solids are transferred from storage containers to laboratory equipment according to safe handling procedures and company SOP.

5. Dispose of laboratory waste
1. Waste is identified according to local, state, and federal regulations, guidelines and guides (OSHA, EPA, NIOSH), and company SOP.
2. Waste is classified according to local, state, and federal regulations, guidelines and guides (OSHA, EPA, NIOSH), and company SOP.
3. Waste is documented according to local, state, and federal regulations, guidelines and guides (OSHA, EPA, NIOSH), and company SOP.
4. Biological waste is treated according to local, state, and federal regulations, guidelines and guides (OSHA, EPA, NIOSH), and company SOP.
5. Radioactive substances are disposed of according to local, state, and federal regulations, guidelines and guides (OSHA, EPA, NIOSH), and company SOP.
6. Controlled substances are disposed of according to local, state, and federal regulations, guidelines and guides (OSHA, EPA, NIOSH), and company SOP.

6. Maintain good housekeeping in the laboratory
1. Laboratory work space is clean and orderly according to OSHA and company SOP.
2. Spills are managed immediately according to company SOP.
3. Labware is cleaned and properly stored.
4. Laminar (fume) hoods are operated according to recognized industry safety guidelines and company SOP.

5. Maintain equipment and laboratory inventories

1. Review equipment for laboratory qualification (Installation Qualification, Operation Qualification, Performance Qualification)
1. All equipment IQs, OQs, and PQs are determined to meet user acceptance criteria according to vendor specifications and company SOP.
2. Routine equipment maintenance is performed per the frequency established in the company SOP.
3. Routine equipment calibration is performed per the frequency established in the company SOP.
4. All instruments and equipment are identified with ID number, date of calibration and due date of next calibration.
5. Specified re-validations or abbreviated re-qualifications are ensured to occur for all equipment.

2. Calibrate laboratory instruments
1. All reference standards used in equipment calibrations are traceable to officially recognized institutes of authority (USP, NIST).
2. All reference standards used in equipment calibration are stored according to company SOP.
3. All reference standards used are within their expiry period.
4. All calibrations are documented according to company SOP.
5. Calibration records are retained per record retention schedules established in the company SOP.

3. Verify instrument calibration
1. All calibrations performed meet the criteria established in company SOP.
2. All laboratory instrumental parameters are verified to be within the range of use according to company SOP.
3. Periodic checks of equipment are performed according to company SOP.
4. Actions to be taken when the calibration or system suitability falls outside of tolerance are followed according to company SOP.
5. All calibration and system suitability failures are investigated and documented according to company SOP.
6. Calibrations performed by contractors are reviewed for compliance, accuracy, and precision according to company SOP.

4. Perform instrument maintenance
1. All equipment and instruments are cleaned periodically according to company SOP.
2. All equipment and instruments are cleaned based on events in the locale of the instrument according to company SOP.

5. Log instrument performance and use
1. All equipment analyses are documented according to company SOP.
2. System suitability is determined prior to conducting analytical testing according to company SOP.
3. The lot numbers or serial numbers of all reference standards used in analytical methods are recorded according to company SOP.

6. Select laboratory chemicals, supplies, and suppliers
1. All reagents and chemicals used in analytical procedures are verified to be of the specified grade according to company SOP.
2. All reagents used are ensured to be within their expiry period prior to use according to company SOP.
3. All suppliers of chemicals, reagents, solvents, and laboratory supplies are ensured to be approved vendors according to company SOP.

6. Maintain and monitor regulatory compliance

1. Follow regulatory requirements
1. Applicable testing procedures from US Pharmacopoeia - National Formulary and other compendia are implemented according to company SOP.
2. Current Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP) regulations are applied according to company SOP.
3. International Conference of Harmonization (ICH) guidelines are applied according to company SOP.
4. Industry standards for electronic record keeping are followed according to company SOP.
5. Training is documented according to company SOP.
6. Career development objectives are prepared, reviewed, and supported according to company SOP.
7. GMP documentation is reviewed and signed according to company SOP.
8. Training sessions on GMP, GLP, company SOP, job function, and job skills are attended as required by company SOP.
9. Designated scores on knowledge assessments are attained according to company SOP.
10. Laboratory quality procedures are demonstrated or described for peers and supervisors.
11. Laboratory quality procedures are practiced according to company SOP.

2. Document sample history and data
1. In-process, or thief, samples are logged according to company SOP.
2. Control sample inventory is conducted according to company SOP.
3. Sample chain of custody is controlled according to company SOP.
4. Controlled substances are disposed according to company SOP.
5. Sample containment and/or packaging for storage or distribution is monitored according to company SOP.
6. Supporting data and reports are provided for annual product review and regulatory submissions according to company SOP.
7. Samples are received and logged according to company SOP.
8. Sampling programs are documented according to company SOP.
9. Data is generated, compiled, and analyzed according to company SOP.
10. Data is managed according to company SOP.
11. Records are retrieved for audits.

3. Establish sample stability protocol
1. Sample stability programs are created according to company SOP.
2. Materials are tested for re-certification according to company SOP.
3. Sample stability studies are conducted according to company SOP.
4. Sample dates and documents are compared according to company SOP.

4. Establish analytical test methods
1. Test methods are validated according to company SOP.
2. Test methods are transferred to end user according to company SOP.
3. Problems in test methods are tracked and reported according to company SOP.
4. Incoming and release testing methods are documented and disseminated according to company SOP.

5. Conduct and document analytical investigations and deviations
1. Data is verified to standards and specifications according to company SOP.
2. Trend analysis is applied according to company SOP.
3. Anomalies are investigated according to company SOP.
4. Root causes to problems are assessed according to company SOP.
5. Analytical problems are solved using scientific principles according to company SOP.

6. Practice continuous quality improvement through established programs
1. Quality management elements and principles are identified and used according to company SOP.
2. Trend analysis is performed and documented according to company SOP.
3. Process diagrams are drawn for pharmaceutical laboratory analyses, identifying the inputs, the process, and the outputs.
4. Statistical tools, such as a fish bone (cause and effect) diagrams, statistical process control, Pareto charts, histograms, and scatter diagrams, are used in the treatment of analytical data sets.
5. Control charts and frequency distribution charts for data sets are developed according to company SOP.

7. Maintain technical information

1. Record experimental details
1. Experimental details are documented according to company SOP.
2. Worksheets and laboratory notebooks are completed according to company SOP.
3. Laboratory notebooks are controlled according to company SOP.
4. Laboratory notebook entries are reviewed according to company SOP.
5. Experimental data is entered in company databases, such as LIMS, according to company SOP.
6. Log books are completed and reviewed according to company SOP.

2. Prepare laboratory documentation
1. Company SOP, protocols, and guidelines are written and revised according to company SOP.
2. Regulatory documentation is written, reviewed, and defended according to company SOP.
3. The change control process is completed according to company SOP.
4. Test results are compiled to generate certificates of analysis (COAs) according to company SOP.
5. Instrument qualification (IQ/OQ/PQ) data is stored according to company SOP.

3. Disseminate technical information
1. Multimedia presentations are prepared and presented.
2. Team meetings are attended according to company SOP.
3. Internal/external analysts are trained according to company SOP.
4. Analytical methods are transferred to external contractors, company sites, and departments according to company SOP.
5. Articles are prepared for in-house, trade, and professional publication according to company policies and procedures.

8. Analyze solid and liquid samples of oral medications using specific dosage form tests

1. Conduct dissolution/disintegration testing of tablets and capsules
1. Dissolution equipment is routinely calibrated according to company SOP.
2. Dissolution tests are conducted using basket and paddle methods according to company SOP.
3. Dissolution test results are recorded and plotted according to company SOP.
4. Dissolution test results are compared to reference standards and related test data according to company SOP.
5. Enteric-coated tablets are tested for acid resistance according to company SOP.

2. Conduct friability testing of tablets
1. Safety guidelines and federal regulations associated with using friability testing apparatus are followed.
2. Friability testing apparatus is used with accuracy and reproducibility to analyze sample tablets according to company SOP.
3. Friability testing apparatus capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in friability data are identified.

3. Conduct hardness testing of tablets
1. Safety guidelines and federal regulations associated with using hardness testing apparatus are followed.
2. Hardness testing apparatus is used with accuracy and reproducibility to analyze sample tablets according to company SOP.
3. Hardness testing apparatus capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in tablet hardness data are identified.

4. Conduct breakability testing of tablets
1. Safety guidelines and federal regulations associated with using tablet breakability testing apparatus are followed.
2. Tablet breakability testing apparatus is used with accuracy and reproducibility to analyze sample tablets according to company SOP.
3. Tablet breakability testing apparatus capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in tablet breakability data are identified.

5. Conduct drug resistance testing of enteric-coated tablets
1. Safety guidelines and federal regulations associated with using tablet coating testing apparatus are followed.
2. Tablet coating testing apparatus is used with accuracy and reproducibility to analyze sample enteric-coated tablets according to company SOP.
3. Tablet coating testing apparatus capabilities are matched to corresponding analysis requirements.
4. Potential sources of error in tablet coating analytical data/results are identified.