1. Purpose
To define the procedures for audit(s) by R&D QA staff, at key external suppliers and vendors being used or considered for use or delivery to the receiving R&D company, to assure their quality status.
2. Scope and Applicability
Suppliers or vendors from external sources for non-clinical safety studies for which a claim of GLP compliance will be made. Examples of key external suppliers or vendors are animals, animal bedding, animal diet, equipment calibration, environmental monitoring and computer software and validation.
3. Definitions
3.1 Supplier
A key supplier is service provider or product provider, as identified in the annualaudit schedule.
4. Responsibilities
4.1 Accountable person responsible for external R&D GLP QA audits:
* Maintain a register of suppliers and vendors to be audited.
* Agree a lead advisor and an audit team, if applicable, for each audit with
Quality Assurance Management Team.
* Issue a list of conducted audits.
* Issue a schedule of audits in time to allow for budgetary requirements.
* Maintain a central record of individuals competent to conduct supplier audits and/or vendor audits.
* Maintain a current template for the audit plans and reports.
* Support and provide background information to an audit team in order to ensure completion of the audit.
4.2 Lead Advisor:
Ensure the audit is planned, conducted and reported.
Ensure contact with the supplier or vendor QA manager or other responsible person to arrange the audit, unless the audit is to be unannounced.
Contact with other relevant staff to ensure that they are aware of the intended audit.
Ensure contact with test facility/test site representatives where appropriate.
Dispatch audit reports to the supplier or vendor audited for response.
Assess responses to audit reports for completeness and appropriateness.
Inform test facility/test site representative, if appropriate of critical issues as soon as possible.
Ensure distribution of the audit report and of response according to current distribution list.
Archive the original of audit report and responses and extra material about/from the supplier or vendor organization.
4.3 Audit Teams:
Where appropriate, technical staff who are experts in the appropriate field may accompany the audit team.
Team members are responsible for assisting in the management and conduct, and when appropriate, taking responsibility for any aspect of the audit in agreement with the lead advisor.
4.4 Heads of R&D QA:
Provide information about the use of suppliers and vendors in nonclinical safety studies to globally accountable person in R&D QA.
Provide information about R&D QA competency for supplier or vendor audits to the accountable person.
5. Procedure
5.1 Audit program
5.1.1 Routine audits
External suppliers or vendors that have not previously been used by the sponsor company will be audited prior to the purchase of a key product for use in a nonclinical safety study, where feasible. External suppliers or vendors or products or services that are regularly used for nonclinical safety studies will be audited at least every third year, apart from software vendors, which will be identified and audited at appropriate intervals.
5.1.2 Requested audits
At the request of facility management or project leader, additional audits of an external supplier or vendor may be undertaken if closer monitoring is considered necessary. Also for cause audits may be requested through the accountable person.
5.1.3 External Quality Assurance reports
Instead of performing a supplier or vendor audit, a Quality Assurance report can be bought from a recognized organization, which has conducted an audit at the facility on behalf of the Pharmaceutical industry. Also audits from other company GXP QA functions can be used, when appropriate.
5.2 Procedure
5.2.1 Notification of announced audit:
The lead advisor will contact the supplier or vendor QA manager or nominated contact to confirm arrangements.
Before the audit, the supplier or vendor QA manager or contact will be advised in writing that an audit is due. They will be asked to ensure that the staff responsible for the organization is available to accompany the advisor(s) and confirm that the scheduled date is acceptable.
An audit plan and any other predetermined issues for audit/examination will be sent to the supplier or vendor QA manager or nominated contact in advance to ensure that any information can be prepared and that data will be available upon arrival.
5.2.2 Conduct of audit:
On arrival at the supplier or vendor the lead advisor must contact the QA manager or nominated contact. If the audit has not been announced in advance, the lead advisor will explain the purpose of the audit.
If actions were required following the previous audit, or an audit/visit by the facility management or project representative, the lead advisor must have available a copy of the appropriate report in order to check that they have been completed.
Any findings during the course of an audit must be discussed at the time with the staff accompanying the audit team. If the staff does not have the necessary authority to agree an action or agreement cannot be reached, discussions may need to be undertaken with the supplier or vendor management.
Obtain documentation to support any non-compliance.
Checklist may be available for use in supplier or vendor audits but will not form part of the audit records.
A careful review of documentation and procedures concerning the manufacturing /production and quality control of the supply will be advantageous as this will show actual procedures and processes used, not just those claimed in SOPs and management documentation.
5.2.3 Exit meeting:
At the end of an audit, a discussion will take place with the supplier or vendors QA and management to advise them of areas of concern and any requirements the sponsor would wish to have resolved and will appear in the report.
Issues of misunderstanding can be clarified and resolved where possible at this meeting.
This meeting shall also be used to indicate where the respective R&D QA staff is pleased with standards and practices.
Confirm any sponsor R&D actions requested.
5.3 Audit report
A QA report will be generated according to the Procedure for GLP QA reports.
5.4 Quality Standard
It is expected that the key suppliers or vendors to have a recognized quality standard in place. If the supplier does not claim compliance with GLP, it is expected for them to have a documented quality system, eg. ISO 9000. As a minimum the following will be verified:
* Training of staff
* Responsibilities
* Documented procedures
* Maintenance of equipment
* Documented production
* Effective quality assurance
5.5 Closing of Audit
Upon receipt of a response, the lead QA advisor will check it for completeness and appropriateness and close the audit.