Part II: Pharmacovigilance Inspection Readiness -- How to Nail Your Upcoming Performance

 

 

So, you have an inspection coming up. Panic sets in, but that doesn’t have to be the case. With some practical planning and prep, your firm can be sure to have a positive experience. Here are some tips for ensuring that successful outcome:

 

REVIEW WHAT THE AGENCIES KNOW ABOUT YOU

 

In preparing for an inspection you should review what an agency knows about your company. That includes reviewing everything that has been sent to an agency such as:  all expedited reports, periodic/annual reports, applications, waivers, and safety reference material (package inserts etc…). If there is a compliance issue with anything that was sent to an agency, such as a late expedited report, there should be documentation of the deviation and any actions implemented to address the root cause of the noncompliance issue.

 

ENSURE ALL PROCESSES ARE IN PLACE

 

Do you have all the processes in place to address regulations and guidances you work under? A gap analysis can be performed between the regulations/guidances and your procedures to verify that you have all the necessary pharmacovigilance processes in place.

 

MAKE SURE YOU ARE INDEED FOLLOWING YOUR PROCESSES

 

The only thing more embarrassing than not having a process in place for a regulation is for an inspector to find evidence that you are not following your own processes. Sounds like common sense but it happens more than you’d like to think. Depending on the type of process involved, ensuring that an approach is being followed can be done by internal audits or systems that will identify a noncompliance in real time so it can be addressed immediately.

 

PUT YOUR INSPECTION A-TEAM IN PLACE

 

Having an inspection team in place ahead of time reduces the stress of an inspection. General roles for an inspection will include; hosts, scribes, preparation room manager, document producers, document reviewers, and runners. The pharmacovigilance department should identify individuals who will present their functional area in an inspection such as case processing, regulatory reporting, medical review, aggregate reporting, literature review, IT, and project management.

 

PRACTICE, PRACTICE, PRACTICE!

 

Like theater, practice and rehearsals are an important part of the process to ensure the team know their roles and feel comfortable responding in a measured, professional manner. All staff should receive basic training on how to behave during an interview by an inspector. Training should include the importance of answering questions truthfully (but only answer the question asked) and if a person doesn’t know an answer to a question, they should respond by saying they don’t know the answer, and if appropriate, say they will get back to them with the answer.

 

For pharmacovigilance staff who will be presenting their functional area during an inspection, they should be given opportunities to practice before a Quality Assurance (QA) person who can act as an inspector. For example, a case processor should practice presenting cases from start to finish and the QA person, acting as an inspector, should challenge the case processor in their decisions on case seriousness, expectedness, and data entry against the source documents and reference materials.

 

Have a few role playing sessions to tackle the toughest potential questions you expect.  In DSN’s experience, several of these “gotcha” questions won’t come up but having planned and prepared for them gives the team added confidence heading into the actual inspection. Better safe than sorry, as the old adage goes.

 

REVIEW INTERACTIONS WITH OTHER DEPARTMENTS

 

An inspector may want to review how the pharmacovigilance department interacts with other departments. For post-marketed safety, this could include other teams who are a source for adverse event reports such as: Customer Service, Sales, Marketing, Medical Information, Legal, and Compassionate Use and Patient follow-up programs. Inspectors will also review communications between safety and quality regarding adverse events that could also be product quality complaints (PQCs).

 

For clinical safety it could be communication with clinical trial management and their providing the pharmacovigilance department information they need for reporting such as: current list of investigators, current safety reference documents (such as an Investigator Brochure), current list of countries where a study is being conducted, and any other studies being conducted with the same or similar investigational product that requires cross reporting.

 

DON'T FORGET THE BASICS

 

There are a few things that will be requested or reviewed during every inspection so there is no excuse not to have these documents in an inspection ready state, such as:

  • Organizational Chart: these should always be up to date and represent the current staffing of the company and pharmacovigilance department. Inspectors will often use the organizational chart to pick which staff’s training records they would like to review and who to interview.

  • Training Records: This should not surprise anyone. When was the last time you were involved in an audit or inspection where no training records were reviewed? A company should have processes in place to continually monitor training compliance. The company’s and pharmacovigilance department’s Training Matrix should also be up to date since the inspector will compare training records to these Training Matrixes.

  • Job Descriptions: these should be current and match the job titles on the organizational chart. There should be some evidence that each individual staff person has read their job description. Best practice is to have signed job role docs on file for each employee, stating they understand the scope of their responsibilities.

  • Employee’s CVs: these should be current. CV’s might be reviewed, along with training records, to determine if an employee is qualified to perform their role.

  • Quality Management System: A company’s overall quality management system will be reviewed to verify processes and systems such as:

    • Are SOPs and other control documents being updated or reviewed according to establish timelines?

    • Is there an internal audit and vendor management program in place and evidence that the programs are being followed?

    • Is there a Business Continuity and IT Disaster Recovery systems in place and evidence of them being tested?

    • Is there a document management system in place and has it been validated?

    • Are there validation records, user acceptance tests and a user manual for the safety database?

So, there are a lot of important considerations to plan for once you’ve been informed of an upcoming inspection or audit. It’s critical to make these planning elements part of your everyday operations, as they are truly intended to elevate your overall quality assurance standards.

 

DSN has helped coach numerous clients on how best to prepare for an inspection. Contact us today to learn how we can help your team deliver a professional performance to rave reviews.

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