News about GMP/cGMP

02.07.2020

EMA: Further update of Q&A on regulatory GMP-requirements during COVID-19

The European Commission, the EMA and the European Network of Medicines Regulatory Authorities have published the third version of the Q&A on regulatory expectations for medicinal products for human use during the COVID-19 pandemic on July 1, 2020. The document has meanwhile grown from originally 7 to now 23 pages and intends to serve pharmaceutical companies as a guide on current adjustments to the regulatory framework due to COVID-19.

 

What's new?


Question 2.2, on the validity period of GMP certificates for manufacturing/importing sites of APIs and/or finished products has been updated.
For pharmaceutical sites within the EEA:

  • The validity of GMP certificates will be automatically extended until the end of 2021 without any further action by the certificate holder. This automatic extension does not apply to changes in the scope of the GMP certificate (e.g. new buildings, new medicinal products). However, it also applies to the validity of time-limited authorisations/registrations, which should also be automatically extended until the end of 2021. Changes to the scope of application are not included here, either.
  • For new sites/facilities that have never been inspected and approved, a distant assessment can be conducted as a first step. If the result is positive, a certificate may then be issued. An on-site inspection should be carried out as soon as circumstances permit. If the result is negative, a time stop will be triggered until an on-site inspection is possible.

For pharmaceutical sites outside the EEA:

  • In principle, the same conditions apply as for sites within the EEA, unless the issuing/supervisory authority takes measures that affect the validity of the certificate. Here, too, new sites/plants are subject to the possibility of a remote assessment by an EEA supervisory authority, in case no corresponding mutual agreement (MRA) exists.
  • Pre-authorisations or routine on-site inspections should be resumed as soon as the COVID-19 restrictions are lifted.

It is emphasised that manufacturers and importers remain obliged to comply fully with all GMP requirements.

Questions 4.2, 4.3, 4.4 on pharmacovigilance measures are new.

  • Question 4.2 deals with the management of corrective and preventive actions. These should be duly recorded as soon as identified and addressed and closed when circumstances permit so.
  • Question 4.3 explains that quality system audits should be carried out regularly and on a risk-based basis. Delays in conducting audits during the pandemic should be well justified and documented and should be resumed as soon as possible. Alternative means such as remote audits should be considered (e.g. telephone calls or video conferences). Utilising questionnaires alone, without supporting evidence, would not be accepted as audits.
  • Question 4.4 deals with on-site inspections. These may not be possible due to travel bans, restrictions on access to facilities or additional health risks for inspectors and inspectors. A remote inspection may also be carried out during pharmacovigilance inspections. Whether it is feasible and whether all technical requirements, e.g. remote access to electronic systems, are met, has to be clarified in advance.

 
As a marketing authorisation holder you should regularly check this EMA-page for new information.


Source:

EMA: Q&A

EMA: COVID-19: What's new?



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