CRO Auditing Content Package

This comprehensive package includes a 150+ audit questionnaire, SOP, and an audit agenda plan:

➢ 1. Nonclinical Study - Contract Research Organization (CRO) Quality Questionaire

To View an EXCERPT from this questionnaire - click here

➢ 2. Nonclinical QA Unit Responsibilities for a Drug Application Sponsor SOP

To view complimentary excerpt click here

➢ 3. GLP Nonclinical Laboratory Physical Audit - Audit Agenda Plan

1. Nonclinical Study-Contract Research Organization (CRO) Quality Questionnaire

This quality questionnaire contains 150+ questions.

To View an EXCERPT from this questionnaire - click here

It is designed to be incorporated into your company’s risk-based approach vendor assessment program. The substitution of a well-designed quality questionnaire, in lieu of the conduct of an actual physical audit is often used by pharmaceutical companies following a successful initial qualification of an audit by a vendor, most notably for requalification or “maintenance” assessments, following the sponsor company’s established external vendor reassessment requirements.

Alternatively, this quality questionnaire can be forwarded to a nonclinical laboratory CRO as a “pre-assessment” tool, for completion by the CRO and review by the sponsor quality department to aid in the design and execution of an actual physical assessment.

This 150+ questionnaire is broken divided into 20 sections, including:

➢Organization and personnel

➢Testing facility management

➢Study Director

➢QA Unit

➢Facilities

➢Animal care facilities

➢Animal

➢Facilities for handling test and control articles

➢Laboratory operation areas

➢Maintenance and Calibration of equipment

➢SOPs

➢Test and control article (TCA) characterization and handling

➢Protocol for and conduct of nonclinical laboratory study

➢Reporting of nonclinical laboratory study results

➢Storage, retrieval and retention of records and data

➢and more…

2. Nonclinical QA Unit Responsibilities for a Drug Application Sponsor (SOP)

 To view complimentary excerpt click here

This 10 page SOP defines responsibilities in the management of nonclinical studies sponsored by the company. In the procedure section of this SOP, 30+ actions and responsibilities are specified. Also includes a nonclinical Quality Assurance QA statement template.

3.GLP Nonclinical Laboratory Physical Audit-Audit Agenda Plan

This three (3) page document provides a template for organizing your audit, including:

➢Audit scope and purpose

➢Audit type

➢Audit category

➢Audit classification

➢Audit team members and titles

➢Audit plan distribution list

➢Etc….

During the conduct of the audit, the following key areas will be addressed Specific items for review include the following areas:

➢Data integrity

➢QA unit

➢Operational support systems related to study data

➢SOPs

CRO Auditing CONTENT Package is only $179...