Discover Other news:
 

COVID-19: Compliance and Quality Updates

07 April 2020

News

AUTHOR: David Crome



The following provides guidance and resources related to COVID-19 quality and compliance related issues.

MHRA Guidance on Covid-19
The MHRA is continually updating its website with Covid-19 Guidance for industry which can be found by clicking here.

Falsified Medicines
The European Medicines Agency (EMA) and MHRA have both issued warnings to the general public about not buying medicines from unauthorised websites and other vendors aiming to exploit fears and concerns during the ongoing Covid-19 pandemic.

To protect from fraudulent sellers, the EMA gives the following recommendations and advice:

  1. Patients should buy medicines only from a local pharmacy or retailer or from an online pharmacy that is registered with the national competent authorities.
  2. All registered online pharmacies have a common logo. Before buying, patients should check that the online pharmacy has this logo.
  3. Customers should click on the logo and will then be taken to the website of the national authority and can check that the online pharmacy is listed on the national authority website.
  4. If the online pharmacy is not listed on the national authority website, one should not order there.
    In general, customers should never buy medicines advertised as cures or preventive treatments for COVID-19.
    ema.europa.eu/en/news/covid-19-beware-falsified-medicines-unregistered-websites

QP batch certification of batches imported from outside the EU
The MHRA will not object to such importation re-testing being omitted where:

  1. Reliance can be placed on measures such as previous testing history and full testing of each batch at the third country manufacturing site.
  2. A retrospective, risk-based, skip lot approach for testing imported batches is undertaken with full testing performed to inform the QP of the continued quality.
  3. Quality attributes that have failed import re-testing should continue to be tested unless robust preventative actions have been implemented and confirmed by the QP
  4. Documentation of the justification and details of omission of tests is retained within the Pharmaceutical Quality System.
    gov.uk/guidance/exceptional-gmp-flexibilities-for-medicines-imported-from-third-countries-during-the-coronavirus-covid-19-outbreak

MHRA Electronic PDF licences and certificates
The MHRA staff are now all working from home so they are issuing electronic pdf copies of licences and certificates, however entries will continue to be uploaded to EudraGMDP.
mhrainspectorate.blog.gov.uk/2020/04/03/process-licensing-update

Keep licence communication details up to date
It is vital for all licence holders to keep their communication details up to date e.g. email address and telephone numbers. The importance of these details being kept up to date has been further reinforced during the coronavirus pandemic, as the MHRA has been issuing important information to licence holders. It is therefore vital that communication details are current. You may have changed your email address or telephone numbers since your last application was submitted.
Please check your contact details now and if you need to vary a manufacturing licence, please do so via the link below and utilise Forms 1V, 2V and 3V.
gov.uk/government/publications/medicines-variation-forms-for-a-manufacturer-licence

Remote Working and QP batch certification
In the modern world it is increasingly common to see flexible, part-time or home working arrangements. Digital connections can allow us to continue to work effectively when we are away from the office. The pharmaceutical industry is no exception, and although some companies employ a part-time or contract Qualified Person (QP), there is still a need to maintain market supply whilst the QP fulfils their other duties or is restricted from travel.

  1. The QP must be able to demonstrate they are fulfilling their wider duties.
  2. Where remote QP certification is employed, it must be described and controlled within the pharmaceutical quality system.
  3. Accurate and up-to-date information must be available to support batch certification and release.
    mhrainspectorate.blog.gov.uk/2020/02/25/maintaining-control-remote-working-and-qp-certification

EMA Nitrosamines risk assessments extended due to Covid-19
The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) as described in information on nitrosamines for marketing authorisation holders from 26th March 2020 to 1st October 2020.
ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities

07 April 2020

News

AUTHOR: David Crome