GDP compliance alerts sounded
We take a look at the latest trends and real world alerts so you can align yourselves with the maturing tastes of GDP compliance regulators.
If you received an unannounced inspection right now, would you feel a wave of confidence or dread? Stay in the loop with how GDP regulation is developing around the globe with these updates.
11,947 medicine packs stolen
The Danish Medicines Authority notified the SUKL that just under 11,950 packs stolen from a shipment in Denmark one night in January. The regulator notes that “the Mandolgin 50 mg package, designated lot number HR0406, should not be located in the legal distribution chain.” Mandolgin is a pain reliever featuring tramadol.
Missing batch of Humira
On the 15th of March, Czech Republic’s medicine authority notified the industry of six falsified packs of Humira with Bulgarian labelling. An EMA warning informed the authority that the batch nos in question were: batch no. 76279XH05, 76279XH16, 70222XD06.
If any operators encounter this batch they are urged to contact the medical authority.
Nigeria: Fake Novartis tablets
The medical regulator for Nigeria notified the public of fake Coartem tablets which entered circulation. The errors on the packaging include, the manufacturer’s name on the fake tablets being listed as NOVRTS. The regulatory body noted: “The use of fake Coartem tablets may result in poisoning (due to toxic substances), treatment failure, development of resistance and even death.”
Anyone with information on the falsified pack is to report to the regulator promptly.
Denmark: Distributor gets non-compliance report
In late 2017, the Danish Medicines Agency filed a non-compliance report after it conducted an inspection at EuroPharma.DK ApS based in Denmark. It outlined that the firm exhibited flaws with the qualification of transporters and forwarders and had poor temperature excursion control on receiving medicines. The report maintains the QA department was understaffed and previous inspection actions had not been corrected properly.
GDP compliance News
UK: Deficiency Data
At the end of 2017, the MHRA published its latest deficiency data for GDP inspections. Around 1425 audits took place in 2016, quality systems and transportation were the top categories attracting major deficiencies.
Responsible Person requirements saw a few major deficiencies with one citation from the regulator noting that a holder had not nominated a responsible person with sufficient knowledge of activities. “The RP was unaware of how additional requirements imposed on certain products by national law would be adhered to, for example, the MHRA published guidance on export that related to ‘controls on strategic goods and drugs used in execution by lethal injection’.”
According to some of the quality management citations, change control was not adequately detailed in some cases. Also, there was no formal process for the review of outsourced activities or written procedure outlining the due diligence arrangements for qualifying contractors.
In regards to transportation, some of the MHRA’s citations included:
- Dirt on the ceiling of a large walk-in refrigerator and no suitable cleaning schedule.
- Lacking temperature mapping for storage areas regarding the placement of monitors.
- Temperature deviations were recorded but did not go through CAPA reporting.
- Incorrect thermometer calibration.
- Gaps in contemporaneous temperature records.
Belgium: Changes to pack and label guidelines
The nation’s Federal Agency for Medicines and Health products (FAMHP) alerted that authorisation holders must adhere to new packaging and labelling guidelines. The modification to the guidelines was conducted to make sure they align with other international requirements.
The main changes include the packaging text as per the QRD template, the use of logos and QR codes, the definition of small packages and the submission of mock-ups.
EU: GMP and GDP non-compliance
The EU GMP and GDP inspectors working group noted that over 24 sites in 2016 received non GMP compliance statements, 12 were located in India, four in China and three in the US. Non-GDP compliance reports were provided to five sites.
The medical agency noted that authorization holders, as of February this year, can choose to report distribution restrictions via the eService.