Method Transfer Protocols 2. Method Transfer Final Report 3. Equipment SOP's (for Acusphere provided equipment) Raw Material/Manufacturing Component/Product Documentation 1. Raw Material and Manufacturing Component Specification Sheets 2. PLGA Microspheres for AI-700 Specification 3. AI-700 Specification 4. Raw Material and Manufacturing Component Release Reports 5. PLGA Microspheres for AI-700 Certificate of Analysis 6. PLGA Microspheres for AI-700 Certificate of Compliance 7. AI-700 Certificate of Analysis 8. AI-700 Certificate of Compliance 9. Bulk Shipping Label Format Manufacturing Documentation 1. Equipment I/OQ Protocols (for Acusphere provided equipment) 2. Equipment SIP Protocols (for Acusphere provided equipment) 3. Equipment SOP's (for Acusphere provided equipment) 4. Qualification or Validation protocols on Hollister-Stier equipment used in conjunction with Acu▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇t or processes (e.g., autoclave - load patterns)
Appears in 2 contracts
Sources: CTM Agreement (Acusphere Inc), CTM Agreement (Acusphere Inc)
Method Transfer Protocols 2. Method Transfer Final Report 3. Equipment SOP's (for Acusphere provided equipment) Raw MaterialRAW MATERIAL/Manufacturing ComponentMANUFACTURING COMPONENT/Product DocumentationPRODUCT DOCUMENTATION
1. Raw Material and Manufacturing Component Specification Sheets 2. PLGA Microspheres for AI-700 Specification 3. AI-700 Specification 4. Raw Material and Manufacturing Component Release Reports 5. PLGA Microspheres for AI-700 Certificate of Analysis 6. PLGA Microspheres for AI-700 Certificate of Compliance 7. AI-700 Certificate of Analysis 8. AI-700 Certificate of Compliance 9. Bulk Shipping Label Format Manufacturing DocumentationMANUFACTURING DOCUMENTATION
1. Equipment I/OQ Protocols (for Acusphere provided equipment) 2. Equipment SIP Protocols (for Acusphere provided equipment) 3. Equipment SOP's (for Acusphere provided equipment) 4. Qualification or Validation protocols on Hollister-Stier equipment used in conjunction with Acu▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇t or processes (e.g., autoclave - load patterns)
Appears in 1 contract
Sources: CTM Agreement (Acusphere Inc)