1. Purpose
To describe the organization, conduct and content of an R&D facility audits by Quality Assurance (QA).
2. Scope and Applicability
This Procedure is applicable to any R&D based on pharmaceutical development.
Facility audits are conducted to assess the compliance of general facilities, support services, computerized systems and any system employed with GLP principles.
3. Definitions
3.1 Controlled document
A controlled document is one which is maintained in such a way as to prevent or track changes which are made to it, is it signed and dated and retained in the QA files.
4. Responsibilities
4.1 QA Management
The head QA is responsible for:
* Ensuring a facility audit program is scheduled and conducted.
* Ensuring a member of QA is nominated to lead each facility audit.
* Provide guidance where needed.
4.2 Quality Assurance Staff
Nominated QA auditors shall be responsible for planning, conducting, reporting and following up the audit as well as ensuring that facility audit records are updated accordingly.
5. Guideline
5.1 GLP Audits
5.1.1 Scheduling of Audits
Biannual facility audits shall be scheduled for each department. The facility audit schedule shall be compiled annually and maintained as a controlled document.
Additional facility audits may be conducted at the request of QA and/or functional management. Additional facility audits will be added to the schedule as needed. Less frequent audits may be accepted in agreement between the function and local GLP
* Documented justification of modified facility audit schedule shall be retained.
* The scope of the audit may include but is not limited to the following, together with the associated systems and records:
* Laboratories
* Equipment
* Animal facilities, care and hygiene
* Storage areas
* Archives
* Dispensary
* Management of test item
* Computerized systems
* Organization and personnel (eg. organgrams, training records, job descriptions)
* Training program
* SOPs/Controlled Procedures
* Weekend/holiday working practices
* Master schedule
* Report production
* Internal supplier audits
* Support services (installations, vet services, statisticians, environmental monitoring, maintenance)
* Additional site specific areas
5.1.2 Conduct of Audits
The previous facility audit report will be reviewed, corrective actions checked, and outstanding items closed if possible. The facility audit checklist will be consulted for guidance on selecting the scope of the audit. Checklists are available as a general guide and do not form part of the audit records.
The results of the audit will be discussed with the relevant functional staff at the end of the facility audit. This information should be used to clarify misunderstandings, identify deficiencies, and recognize areas of compliance.
Findings that are considered critical or major shall be discussed promptly with facility management and relevant Study Directors, if applicable.
5.2 GXP Audits
Facility audits relevant to other GXP areas, such as central archives, technical service, and IS/IT, may be scheduled and coordinated with relevant QA functions, if appropriate. Nominated QA auditors shall conduct the facility audit according to the above procedures in cooperation with the responsible GXP audit team. Distribute the report to appropriate GXP management.