Pre-Qualification SOP Template Package

With this package you receive six (6) SOP templates, four (4) flowcharts, three (3) pre-qualification activity flowcharts - 35+ pages of SOP Templates.

➢1. SOP-Performing Design Qualifications

➢2. SOP-Performing Factory Acceptance Tests (FATs)

➢3. SOP-Performing Site Acceptance Tests (SATs)

➢4. SOP-Performing Commission Tests

➢5. SOP-Performing Vendor Surveys

➢6. SOP-Performing Vendor Audits

1. SOP - Performing Design Qualifications

This four (4) page SOP template provides guidelines on how to execute Design Qualifications, which are performed to assure that the equipment’s design meets the requirements of the user(s). Procedure section of this SOP includes 12 steps to effectively execute design qualifications.   

2. SOP-Performing Factory Acceptance Tests (FATs)

Limited time: Download this entire SOP - Complimentary NOW - click here

This seven (7) page SOP template provides guidelines on how to perform Factory Acceptance Tests (FATs), which are performed prior to receipt of critical equipment at the owner’s/customer site. It outlines the content of the FAT protocol, FAT report and requirements and approval of each. Procedure section of this SOP includes sections on Developing the Protocol, FAT Execution and FAT Final Report. A FAT flowchart and pre-qualification activity flowchart are also included.  

3. SOP-Performing Site Acceptance Tests (SATs)
This seven (7) page SOP template provides guidelines on how to perform Site Acceptance Tests (SATs), which are performed at the owner’s/customer’s site after receipt and installation of critical equipment. It outlines the contents of the SAT Protocol, SAT Report, and requirements and approval of each. A SAT flowchart and pre-qualification activity flowchart

4. SOP-Performing Commissioning Tests
This eight (8) page SOP provides guidelines on how to perform Commission, which is performed after receipt and installation of critical equipment at the owner’s/customer’s site. It outlines the contents of the Commissioning protocol, commissioning report and requirements and approval of each. A Commissioning flowchart and pre-qualification activity flowchart

5. SOP-Performing Vendor Surveys
This five (5) page SOP provides guidelines on how to execute Vendor Surveys, which are performed to preliminarily evaluate the “quality” of said vendor. A Vendor Audit flowchart is also included.  

6. SOP-Performing Vendor Audits
This six (6) page SOP provides guidelines on how to execute Vendor Audits, which are performed to evaluate the “quality” of said vendor. Procedure section of this document includes 25+ steps to effectively execute a vendor audit. A Vendor Audit flowchart is also included.
About the Author

Charlie Neal, Jr., has 30+ years of experience in GMP-regulated industries. He has held lead positions in Research, Development, Process Engineering, Manufacturing, Validation, Quality Assurance and Sales & Marketing. He has acquired hands-on technical experience by working in sterile drugs, solid dosages, liquids, devices, APIs, and biotech industries. He has been responsible for process development, scale-up, optimization, validation, validation strategy development, technology transfers, quality, compliance, validation project management, sales support and sales management. In addition to having strong people management skills, he has developed and maintained quality systems, and proficiency with document management, CAPAs and deviation systems. He also has familiarity with Six Sigma and Lean tools, and experience in conducting and fielding audits.

He has presented papers on Technology Transfers (Japan), validation and validation documentation. He authored a chapter on Transdermal Process Validation, published in the 3rd edition of the technical reference book entitled, “Pharmaceutical Process Validation”.  He has held membership on the Editorial Advisory Board for the Journal of Validation Technology since 1998.

Pre-Qualification SOP Template Package is only $99.00

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