At the BioProduction Congress in Dublin, Ireland this month, the HPRA’s Dearbhla Cullen told delegates Irish firms are given more than one month’s notice to prepare for good manufacturing practice (GMP) inspections, and should be prepared for regulatory visits.
“Our inspection notices go out six weeks before the visit. People should be inspection ready,” she said, adding that preparing for site visits and cooperating with inspectors gives a good impression to regulators.
Pre-inspection
According to Cullen, firms that perform internal inspections should be aware of potential risks before inspectors arrive, and are consequently at an advantage.
“The first thing we’re going to do is review the last inspection report, which is obviously the best thing for the company to do,” she said.
Cullen said it is important to ensure all corrective and preventative actions (CAPAs) are complete, and to determine if there are other areas of your site – including the quality control (QC) lab, production and warehouse areas – where these actions could be applied.
Making sure your license reflects current activities, and reviewing the risk review register – which reflects potential issues on site – are also tasks that should be self-identified, said Cullen.
“Obviously the inspectors will be going through your deviations, or going through your quality risk analysis (QRA), and if you have issues that you don’t identify, we will be wondering what’s fallen down in the quality system,” she said.
Housekeeping and cleanliness should also be a priority, said Cullen.
“It’s true that first impressions do last, we do realise that we’re seeing sites at their best, so if it doesn’t look good during our visit, we do wonder what it’s going to look like the rest of the time,” she said.
During the inspection
Cullen said making staff available to speak with inspectors and dealing with issues head on reflects well on the company during GMP inspections.
“When you have a major issue, please prepare a presentation,” she said.
“This shows us that you know what you’re doing, you have a plan in place, and it gives good feedback to the inspectors that there is good control on site,” she added.
Making personnel available to talk with inspectors also gives a good impression, she said.
“If you have people in place that can talk exactly about what’s going on in the area, it gives the impression that people know what they’re doing and can address an issue if it arises,” said Cullen.
“It also means that when it does come to points where it’s unclear what the issue is, we have already built that relationship of discussion and clarification can be reached quickly,” she added.
Post-inspection
Cullen said when documentation is made available to the HPRA promptly, it promotes the idea that good systems are in place.
The HPRA generates its inspection report approximately 14 days after the last date of the site visit, and when possible leaves an electronic version of the draft summary report before leaving the firm.
“This gives you time to get working on [any potential issues] immediately. Once the inspection report has been issued, the company then has 21 days to reply,” she explained.