1. Purpose
The purpose of this Procedure is to describe the R&D GLP Quality Assurance (QA) records to be retained.
2. Scope and Applicability
This Procedure (IP) applies to R&D GLP QA.
3. Definitions
3.1 Archive
An area with physical, logical and environmental security designed to protect contents from untimely deterioration
4. Responsibilities
4.1 Heads R&D QA
The heads R&D QA shall ensure GLP QA records are controlled and retained in accordance with GLP and company requirements and that the GLP QA records produced in their groups are archived. GLP QA study audit/review reports and responses and study related communication shall be archived not later than four weeks after finalization of the study report. All other GLP QA records, with the exception of QA staff records, shall be archived within two years of creation.
4.2 Quality Assurance staff
QA shall archive GLP QA records produced at their respective site.
5. Guideline
5.1 GLP QA records to be retained in R&D GLP QA archive
– GLP policy (where applicable)
– Internal Procedures (signed originals)
– GLP IP Index
– Global GLP IP distribution list
– GLP IP discontinuation memos
– Global R&D GLP QA guidance documents (signed originals)
– Approved checklists (signed originals)
– Global R&D GLP QA organogram
– Global R&D GLP QA staff list
– Audit schedules (CRO, supplier and vendors)
– R&D GLP Test facility and test site management list
– GLP QA Due Diligence Reports
– Role descriptors
– Curriculum vitae
– Competency statements
– Training records
– Training attendance logs (when R&D GLP QA provide training)
– Audit schedules (process based and facility)
– GLP QA audit/review reports and responses
– Relevant QA communications with Study Directors/Principal Investigators and suppliers
– Deviations from IPs
– Site GLP IP distribution list
5.3 Retention Period
Records are retained according to local/regional/global retention schedules and documented retention and disposal procedures.