Inspection Checklist

Below is a list of the questions you can ask in your organization to ensure that you are better prepared to survive an inspection in drug safety without a warning letter or critical findings. The list is not all inclusive, but it will be updated when new requirements become available or if there are proposals from the readers

Pharmacovigilance Organization

• Detailed Description of Pharmacovigilance Systems (Section 2.2 in EU Volume 9A)

• Contact details of staff to be interviewed

• Organizational charts

• List of employees (names and functions)

• Job/role descriptions

• CVs

• Training curriculum pr staff group and training records

 
European Qualified Person (QPPV)

• Qualified Person for Pharmacovigilance CV, training records and contact details

• Deputy Qualified Person for Pharmacovigilance CV, training records and contact details

• Notification documentation to health authorities for QPPV and deputy

• Documentation for the roles and responsibilities of the Qualified Person in the form of an SOP and job descriptions

• Document that the QPPV or deputy can access PV system for collection of ADRs at least at one point in the EU and can they perform database searches

• Document that appropriate procedures exist to ensure single serious adverse drug reactions are reported to the competent authorities in accordance with regulations

• Document QPPV oversight of all PSURs and other regulatory aggregate reports?

• Document QPPV awareness of all company sponsored post authorization safety studies, initiation, conduct and reports

• Document QPPV participation in regular safety reviews

• Document the company's escalation procedure for safety issues

• Document the QPPV awareness of all requests for information received from competent authorities and of all responses

• Document the QPPV awareness of all signal generation activities and ongoing safety issues

• Document that a list of all ongoing safety studies is created monthly

• Document that the QPPV is aware of arrangements with partner/distributor/vendor agreements for meeting pharmacovigilance obligations

• Document that the QPPV has oversight with global compliance and has sufficient power to get necessary changes implemented to ensure compliance

• Document that the QPPV receive audit/inspection findings of PV relevant procedures

• Document that the QPPV has access to suitably qualified medical personnel at all times if not qualified themselves

• Document comprehensive out of hours procedures for contacting the QPPV or deputy 24 hours/day, 365 days/year

• Document that access to the QPPV has been tested

  
Roles, Responsibilities and Training

• Document that all members of staff involved in pharmacovigilance activities have appropriate training records

• Document that you have a training SOP implemented

• Document training program and schedule as well as appropriate training curriculum

• Document how staff members are selected for training/curriculum

• Document how and CVs are maintained and signed off by staff members

• Document the update frequency of CB updates (minimum annually and at job change)

• Document how job descriptions are updated and assigned. (note that recent warning from FDA related to inconsistency in job descriptions/qualifications)

• Document details of training with evidence (eg. trainer’s signature; signature of attendees)

• Documentation of knowledge of all relevant SOPs and related processes

• Document evidence of competency appraisal/interval of appraisals, performance management

• Document that you have current legislation available for staff in English and how it is maintained

• Document your process for keeping updated with new legislation and how it is operationalized

• Document how drug safety employees are trained on any new legislation and the operational implications

• Document current organograms for all functions

• Document how all staff is trained in handling potential drug safety or product complaint information they may encounter.

• Document how incoming safety or complaint information routed

• Document specific sales force training and document that all sales force staff has been trained and retrained

Policies and Procedures

• Document your document hierarchy that covers identification, version control and training requirements

• Document your quality system hierarchy including all relevant SOPs, Manuals, templates, metrics and corrective action systems

• Document your change control for modification existing processes and introduction of new procedures

• Document how version control is implemented

 
Record retention and Archiving

• Document your system for logging and distribution of all incoming documents

• Document your system for archiving documents (in- and outgoing documentation)

• Document how access rights are assigned and maintained (database and documentation)

• Document where do you keep treatment codes and how do you guarantee restricted access

• Document fire protection and access protection

• Document your company's record retention policy

• Document secure document storage conditions

• Document regular inspection of any off-site archiving facility to ensure appropriate storage, retrieval and environmental monitoring

• Document controlled list of individuals authorized to retrieve documents from an off-site archive facility

• Document the process for ensuring that retrieved documents are returned

  
Product Complaints

• Document your procedure for handling technical and product complaints and possible associated adverse events

• Document interactions and reconciliation between Manufacturing, Drug Safety and Medical Information

• Document how safety trends in product batches are identified

  Expedited and Periodic Reports

• Document how you monitor time lines for expedited and periodic reports

• Document process of unblinding and distribution of unblinded reports

• Verify that you can provide a complete list PSURs, Annual Safety Reports and bridging reports

• Verify that you can provide a list of due dates and actual submission dates.

 
Risk Management

• Document the process of risk management

• Document the process, roles and responsibilities of safety related type II variations

• Verify that you can provide a list of safety type II variation including time lines

  
Medical Information

• Document the process that describes how adverse event information received by Medical Information is transferred to Drug Safety

• Document the process for checking that all adverse event reports received by Medical Information are notified to Drug Safety

• Document the procedure for handling of adverse events received out of normal office hours

• Document contact information of physician at home to handle inquiries

 
Regulatory Affairs

• Verify that you can provide a list of all your company products including registration status

• Document that your Regulatory Affairs function track all requests and responses for information received from a competent authority

• Document that you have a formalized procedure for contacting appropriate personnel should an urgent request for safety information from a competent authority be received out of normal working hours

Quality Management System  

• Document that you have implemented management oversight with compliance related activites

• Document how you measure performance of your drug safety activities

• Document how do you update Core Safety Information, Investigator Brochures, SPCs, Risk Management plans etc. and the associated decision process.

• Document your organization program for global pharmacovigilance system audits

• Verify that you can provide a history of pharmacovigilance system audits and reports from past audits

 
IT Systems

• Document full validation documentation for your safety database including IQ, OQ and PQ

• Verify that you can document a structured system development process from your system provider

• Document system administrator and roles

• Verify that your safety system has a comprehensive and readable audit trail

• Document who has access to the safety system and how is access controlled

• Document appropriate MedDRA version implementation and that consistent coding principles are applied

• Document how are dictionary updates handled and verify update records

• Document disaster recovery plan for the safety system

• Document regularly testing of disaster recovery plan