Home Industry Sectors Pharmaceuticals By Laboratory Santa Fe Springs, US - Health Sciences

Standard Operating Procedures

Index No

Title

100

General and Corporate SOPs

101

CONTROL OF STANDARD OPERATING PROCEDURES AND TEST METHODS

110

ORGANIZATION AND FACILITIES

120

ROLES AND RESPONSIBILITIES

140

DOCUMENTATION OF TRAINING AND QUALIFICATIONS OF EMPLOYEES

170

SAMPLE AND WASTE DISPOSAL

190

COMPLAINT RESOLUTION

200

RADIATION SAFETY

210

HANDLING CONTROLLED SUBSTANCES

220

CHANGE CONTROL

240

HOUSEKEEPING, PEST CONTROL AND SECURITY

250

INTERNAL, THIRD PARTY AND VENDOR AUDITS

260

VENDOR QUALIFICATION

270

LABORATORY NON-CONFORMANCES, INCLUDING CORRECTIVE AND PREVENTATIVE ACTIONS

500

STUDIES PERFORMED UNDER GOOD LABORATORY PRACTICES (GLP) PROTOCOLS

900

Manuals

900

SAFETY MANUAL

930

QUALITY ASSURANCE MANUAL

1000

Clerical SOPs

1000

FILE STORAGE AND RETRIEVAL

1500

RECEIPT OF SAMPLES AND REVIEW OF CONTRACTS

1510

TEMPERATURE RECORDING AND REQUIRED LABELING FOR REFRIDGERATORS, FREEZERS, AND CONTROLLED TEMPERATURE AREAS MONITORING

1520

FOREIGN SOILS

1530

SAMPLE PRESERVATION CHECKING

2000

General Lab SOPs

2100

SOLUTIONS, REAGENTS, AND STANDARDS PREPARATION AND DOCUMENTATION

2110

CALIBRATION AND USE OF ANALYTICAL BALANCES

2120

DATA MANAGEMENT AND COMPUTING SYSTEMS

2130

NETWORK BACKUPS AND MAINTENANCE

2140

THERMOMETER CALIBRATION

2150

SUMMA CANISTERS

2160

LABORATORY DATA REVIEW AND GENERATION OF REPORTS

2170

CALIBRATION AND MAINTENANCE OF MECHANICAL PIPETTES

2180

DETECTION LIMITS

2190

SIGNIFICANT FIGURES AND ROUNDING

2200

WATER PURIFICATION

2220

METHOD VALIDATION

2230

OUT-OF-SPECIFICATION (OOS) INVESTIGATIONS

2240

GOOD DOCUMENTATION PRACTICES

2250

ANALYTICAL INSTRUMENT QUALIFICATION AND FACILITY EQUIPMENT MAINTENANCE

2260

CONTROL AND USE OF LABORATORY NOTEBOOKS, LOGBOOKS AND WORKSHEETS

2270

SOP FOR DATA ARCHIVE
2280 REAGENT CONTROL AND INVENTORY
2290 CALIBRATION AND USE OF pH METERS

2800

GLASSWARE CLEANING

2810

BNA EXTRACTIONS

2820

PESTICIDE EXTRACTION

2830

525 DRINKING WATER SAMPLE EXTRACTION

2840

PESTICIDE AND PCB CLEAN-UP

3000

Gas Chromatography

3000

VOLATILE ORGANICS IN DW BY EPA 502.2

3010

EDB & DBCP in DRINKING WATER

3020

NITROGEN AND PHOSPHORUS CONTAINING PESTICIDES

3030

HALOGENATED/AROMATIC VOLATILE ORGANICS

3040

HALOGENATED/AROMATIC VOLATILE ORGANICS

3050

FUEL HYDROCARBONS BY MODIFIED EPA 8015

3060

VOLATILE ORGANICS IN AMBIENT AIR.....

3070

VOLATILE HYDROCARBONS (C1-C9) AND PERMANENT GASSES...

3080

PHENOXY ACID HERBICIDES BY GC

3090

ORGANOCHLORINE PESTICIDES/PCBs BY GC

3100

ORGANOPHOSPHORUS PESTICIDES BY GC

3110

SILICONES

3120

GC MAINTENANCE

3130

INDUSTRIAL HYGIENE

3140

VOLATILE SULFUR

3150

ACRYLAMIDE IN POLYACRYLAMIDE POWDER BY GC/TSD

3160

EG AND ECH IN ALLERGAN AMO VITRAX

3170

ORGANIC VOLATILE IMPURITIES BY USP

3180

EG & ECH IN WATER

3190

ACETAMIDE BY GC

3200

BUTYLTIN

3210

DMSO - GC/FID

3220

ALCOHOL SCREEN

3230

BHT BY GC/FID

3240

ETO BY GC/FID HEADSPACE

3250 OVI IN *******
3260 ETHYLENE OXIDE, PROPYLENE OXIDE, AND 1,4-DIOXANE IN POLOXAMER
3270 RESIDUAL SOLVENTS IN PHOSPHOTIDYLCHOLINES BY GCFID
3280 FREE FATTY ACID METHYL ESTERS BY GCFID

3290

METHANE BY GC-FID (HEADSPACE)
3300 VOLATILE FUEL HYDROCARBONS
3310 9-ACETYLANTHRACENE PURITY BY GC/FID
3320 TOTAL IMPURITIES INCLUDING METHANOL IN METHYL FORMATE BY GC/FID
3330 ETHYLAMINE BY GC/FID
3340 HYDRAZINE BY GC
3350 DETERMINATION OF TRIBUTYL PHOSPHATE BY GC/TSD
3360 GC ANALYSIS FOR ORGANIC CONSTITUENTS

4000

Liquid and Ion Chromatography

4000

PNAs

4010

ALDEHYDES AND KETONES BY HPLC

4020

GENERAL ANIONS

4030

CARBAMATE-UREA PESTICIDES BY HPLC

4040

GENERAL CATIONS

4050

HEXAVALENT CHROMIUM BY EPA 218.6

4060

PHENOL AND CRESOLS BY EPA TO-8

4070

MOD. NIOSH 7600

4080

IC/LC MAINTENANCE

4090

MONOFLUOROPHOSPHATE IN TOOTHPASTE

4100

ANTIOXIDANTS BY HPLC

4110

GLYPHOSATE

4120

DIQUAT BY IC

4130

ORGANIC ANIONS

4140

HEXAVALENT CHROMIUM DIGESTION

4150

AZIDE

4170

PERCHLORATE BY IC
4190 Merit (IMIDACLOPRID)
4200 ACRYLAMIDE, ACRYLONITRILE, and ACROLEIN BY HPLC (EPA 8316)
4210 ASSAY OF SUCROSE BY IC
4220 ACETATE AND TRIFLUOROACETATE BY IC
4230 PHOSPHATE IN HYALURONDIDASE FORMULATIONS BY IC
4240 ASSAY OF LACTOSE IN HYALURONIDASE FORMULATIONS BY IC
4250 EDTA IN HYALURONIDASE FORMULATIONS BY HPLC
4260 ANALYSIS OF THIOLS BY PRECOLUMN DERIVATIZATION/HPLC
4270 BROMATE BY IC
4280 ANALYSIS OF TFA, ACETATE, AND FLUORIDE IN ******
4290 SODIUM DICHLOROACETATE BY IC
4300 BORATE BY IEC

5000

Mass Spectrometry

5000

SEMI-VOLATILE ORGANIC COMPOUNDS BY EPA 525

5010

SEMI-VOLATILE ORGANIC COMPOUNDS BY GCMS

5020

VOLATILE ORGANICS IN AIR BY GCMS

5030

GCMS SCREENS

5040

TCLP-ZHE LEACHATE PREPARATION..

5050

VOLATILE ORGANIC COMPOUNDS BY GCMS

5060

VOLATILE ORGANIC COMPOUNDS BY EPA 524.2

5070

TCLP SEMIVOLATILES

5080

USP 467 METHOD II

5090

PURGEABLE VOLATILE ORGANIC COMPOUNDS BY EPA METHODS 1666/524.2

5091

VOLATILE ORGANIC COMPOUNDS BY EPA METHOD 1666

5120

HP5973 GCMS MAINTENANCE

5130

ECH & EG IN NA HYALURONATE

5140

1,4-DIOXANE BY GCMS

5160

USP METHOD I & IV
5170 PNAs BY GCMS-SIM
5180 PESTICIDE SCREEN
5190 1,4-DIOXANE BY HEADSPACE GCMS
5200 QUALITATIVE DETERMINATION OF ADDITIVES IN METHYL METHACRYLATE
5210 DETERMINATION OF IMPURITES IN BONE BLACK
5220 DETERMINATION OF RESIDUAL SOLVENTS BY GCMS
5230 FURFURYL, FURFURAL, AND IPA BY GCMS
5240 ACRYLAMIDE BY ISOTOPE DILUTION GCMS
5250 MONOMERS
5260 ETHANEDITHIOL IN PROTEINS/PEPTIDES BY GCMS
5270 1,2,3-TRICHLOROPROPANE BY ISOTOPE DILUTION GCMS

5280

TRIETHYLAMINE BY GCMS

5510

PERCHLORATE BY LC-MS/MS

5520

p-CHLOROBENZENESULFONIC ACID (pCBSA) BY LC-MS/MS

5530

ARISTOLOCHIC ACID BY LC-MS/MS

5540

POLYSORBATE 80 BY LC-MS

5550

LOVASTATIN BY LC-MS/MS

5560

ALBUTEROL SULFATE BY LC-MS/MS

5570

MOLECULAR WEIGHT DETERMINATION BY ELECTROSPRAY MASS SPECTROMETRY

5900

CARBON, HYDROGEN AND NITROGEN BY COMBUSTION

6000

Spectroscopy

6000

CRYSTALLINE SILICA BY NIOSH 7602

6010

TOTAL HYDROCARBONS AND TOTAL PETROLEUM ....

6020

OIL & GREASE

6030

INFRARED SPECTROSCOPY

6040

OIL MIST-NIOSH

6050

IR MAINTENANCE

6500

NUCLEAR MAGNETIC RESONANCE

7000

Metals

7000

TOTAL BROMINE BY ICPMS

7020

MERCURY IN FISH

7030

TOTAL ORGANIC LEAD BY ICPMS

7040

TRACE METALS BY ICPMS

7050

URANIUM IN GROUNDWATER

7060

ALUMINUM IN PROTEIN

7070

PQ3 MAINTENANCE

7071

PQ4 MAINTENANCE

7080

SELECTED TRACE METALS IN POLY(DL-LACTIDE) POLYMER

7090

BORON BY ICPMS

7100

LI, AL, AND FE IN PEACH PEACH TWIG BORER (PTP) TECHNICAL

7110

IODINE IN PLASMA AND URINE

7120

HEAVY METALS

7130

LEAD IN ANTACIDS

7140

HYDRIDE ICPMS

7150

ELAN MAINTENANCE

7160

SILVER AND PALLADIUM IN ******* BY ICPMS
7170 SELECTED METALS IN SODIUM HYALURONATE
7180 SELECTED METALS IN LANTHANUM CARBONATE
7190 METALS BY ICP-OES
7210 TRACE METAL IMPURITIES IN SELENIUM DIOXIDE BY ICPMS
7220 TOTAL IRON CONTENT ASSAY IN ****** BY ICP-OES
7230 ARSENIC IN ********* BY ICPMS
7240 ARSENIC SPECIATION
7250 IODINE BY ICPMS
7260 LA IN SWABS BY ICPMS (FOSRENOL CLEANING VALIDATION)
7270 OPERATION OF AGILENT 7500CE ICPMS
7300 SILVER IN PLASMA BY ICPMS
7310 FREE GADOLENIUM SPECIATION IN GD-CHELATE AND DRUG PRODUCT BY LC/ICPMS
7320 SELECTED TRACE METALS IN EVAL POLYMERS
7330 SELENIUM IN WHOLE HUMAN BLOOD BY ICPMS
7340 DETEMINATION OF TIN IN LACTIDE/GLYCOLIDE COPOLYMERS

7500

OPERATION AND MAINTENANCE OF THE HYDRA AFG+ MERCURY ANALYZER

7600

METALS BY GFAA

7700

X-RAY FLUORESCENCE

7800

ACID DIGESTION OF SOILS....

7810

EP TOX LEACHATE...

7820

GLASSWARE CLEANING

7830

MICROWAVE DIGESTION

7840

TCLP LEACHATE PREPARATION.....

7850

WET LEACHATE PREPARATION....

7860

ACID DIGESTION OF FILTERS

7870

HIGH PURITY REAGENTS: OPERATION AND MAINTENANCE OF THE MILESTONE DUOPUR SUBBOILING DISTILLATION UNIT

7880

SAMPLE PREPARATION FOR ICPOES AND ICPMS ANALYSIS

7890

STANDARDS PREPARATION FOR ICPOES AND ICPMS ANALYSIS

8000

Wet Chemistry

8000

ACIDITY

8010

ALKALINITY

8020

AMMONIA BY NESSLERIZATION

8030

CHEMICAL OXYGEN DEMAND

8040

COLOR

8050

TOTAL AND AMENABLE CYANIDE

8060

DENSITY BY ASTM D1475

8070

FIXED AND VOLATILE SOLIDS

8080

FORMALDEHYDE BY NIOSH 3500

8090

HARDNESS

8100

WATER CONTENT BY KARL FISCHER TITRATION

8110

TOTAL MERCAPTANS IN WASTEWATER

8120

TOTAL PHENOLS

8121

TOTAL PHENOLS

8130

REACTIVE CYANIDES

8140

REACTIVE SULFIDES

8150

SALINITY

8160

SETTLEABLE SOLIDS

8170

pH OF SOIL AND WATER

8180

ELECTRICAL CONDUCTIVITY/SPECIFIC CONDUCTANCE

8190

SPOT TEST FOR CYANIDES IN CLEAN WATER

8200

SULFIDES IN SOILS AND WATERS

8210

SURFACTANTS (MBAS)

8220

TOTAL DISSOLVED SOLIDS

8230

TOTAL ORGANIC CARBON - WALKLY BLACK

8240

TOTAL SOLIDS

8250

TOTAL SUSPENDED SOLIDS

8260

TURBIDITY

8270

VOLATILE CONTENT

8280

FLASH POINT

8290

BIOLOGICAL OXYGEN DEMAND

8300

FLUORIDE BY ISE

8310

RESIDUAL CHLORINE

8320

SOLUBLE SULFIDE

8330

VITAMIN C ASSAY

8340

SCHIMADZU UV/VIS SPECTROPHOTOMETER

8350

BETA CAROTENE

8360

MELTING RANGE

8370

ORION 950 DISPENSER

8380

PHOSPHORUS SM45

8390

RESIDUE ON IGNITION

8400

LOSS ON DRYING

8410

IODINE TITRATION

8420

HEXAVALENT CHROMIUM BY COLORIMETRY
8430 ANALYSIS OF ******
8440 ASSAY OF t-BUTYLHYDROPEROXIDE
8450 GRAVIMETRIC ASSAY OF SELENIUM DIOXIDE
8460 DETERMINATION OF TWEEN-80 CONTENT
8470 HEM AND SGT-HEM EXTRACTION AND GRAVIMETRY BY EPA 1664

9000

STABILITY (Retired)

 

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