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201 Responsibilities ...Personnel SDs and
PIs |
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233 Operation and Maintenance of Shaker/Incubator, rotators, vortexers |
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202 Maintenance of Master Schedule |
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234 Use of IT Systems and Facilities |
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203 Non-clinical Study Plans |
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235 Business Continuity and Disaster Recovery |
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204 Check of GLP and GCP Plans and Protocols by QA |
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236 Equipment Operation: General Requirements |
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205 Laboratory Reagents |
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237 Operation and Checking of Thermometers and Data Loggers |
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206 Operation and Maintenance of Fridges and Freezers |
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242 Method Development |
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207 Multi-Site Studies |
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243 Study Quality Control (QC) Checks |
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208 Data Recording and Management |
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244 Clinical Analyses and Clinical Analytical Plans (CAP) |
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209 Test Sample Management |
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245 Action for Unexpected Events, Deviations and CAPA |
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210 QA Inspections and Audits |
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246 Alert Reporting |
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212 Study Reports (Final, Phase and Interim Reports) |
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247 Routine Analysis, Repeat Analysis and Incurred Sample Reanalysis |
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213 Report Audit |
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248 Operation of LC-MSMS analysers |
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214 Operation and Maintenance of Balances |
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249 Electronic Data Transfers |
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215 Operation and Maintenance of pH Meters |
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250 Computer Validation Test Script Execution |
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216 Archive Transfer and Withdrawal |
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251 Management and administration of the UoAGLPTF Computer Systems |
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217 Archive Operation |
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252 EDAMS: Routine Use |
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218 Method Validation for Bioanalysis |
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253 Operation and Maintenance of the Millipore Water Purification Units |
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219 Management of Methods |
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255 Computer Validation Audit |
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221 SOP Preparation and Management |
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256 Operation and Maintenance of the Sample Concentrator |
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222 Facility Housekeeping |
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258 Freezer Alarm System |
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225 Contracts, Contractors and Service Providers |
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259 Use of the NuGenesis LMS |
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226 Validation of Computer Systems |
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260 QA Procedures for Report Numbering, Classification and Escalation ... |
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227 External Inspections and Visits |
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261 Backup Generator |
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228 Training and Training Records |
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262 Deviation and CAPA tracking |
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230 Operation and Maintenance of Pipettors |
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263 Document Scanning for Retention and Backup |
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231 Test and Reference Items and Standards |
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264 Operation and Maintenance of Thermo ULT Freezers |
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232 Operation and Maintenance of Centrifuges |
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301 Handling and Shipping of Reference Material |
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306
Handling of complaints and product recall |
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302 Reference material manufacturing, planning and reporting |
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307 Use of the Inert Atmosphere Box |
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303 Investigation of Out of Spec and Anomalous Test Results |
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308 Cleaning of equipment and the workspace |
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304 Contracting and monitoring of external analytical services |
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309 Use of Greisinger 3600 oxygen meter |
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305
Creation and control of certificates of analysis |
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310 Quality Assurance for the Reference Standards Laboratory |
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List of reissued SOPs
To indicate that you have read one or more electronic SOP(s), please sign the red book if you can, or list them with version numbers in an email to the SOP Coordinator. |
