GMP Inspection of Manufacturers of Veterinary Medicines in the Context of COVID-19

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The COVID-19 pandemic is a serious obstacle to inspections of medicinal products manufacturers for compliance with the requirements of Good Manufacturing Practice (GMP). This primarily relates to on-site inspections. Therefore, the regulatory authorities of many countries around the world began to consider alternative measures to ensure the safety of imported products. In this short review, we will look at some of the measures taken by foreign regulators who are responsible for inspecting manufacturers of medicinal products for veterinary use.

EUROPEAN UNION

The European Commission, European Medicines Agency (EMA) and the Coordination Group for Mutual Recognition and Decentralised Procedure – Veterinary (CMDv) have issued guidance on adaptations to the regulatory framework to companies that develop, manufacture and distribute veterinary medicines in order to address some of the constraints posed by the COVID-19 pandemic.

According to the jointly developed document “Questions and answers on regulatory expectations for veterinary medicinal products during the COVID-19 pandemic”, regulatory rules for veterinary medicines should be applied with greater flexibility in the context of COVID-19 when necessary to mitigate the risk of supply disruptions caused by the pandemic. The guidance aims to ensure that high-quality, safe and effective veterinary medicines that are essential for protecting animal and public health continue to be available during the public health crisis.

The Q&A document sets out areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders in the veterinary sector may be faced with in the context of the pandemic. These measures cover different areas of regulation, including:

  • marketing authorisation procedures;
  • safety monitoring;
  • inspections of manufacturing facilities and GMP for veterinary medicines [1].

Section 2 of Part A of this document provides answers to issues related to GMP inspections, certificates and work of the Qualified Person.

Question 2.1.: Which measures will be taken in respect of GMP certificates and authorisations to manufacture/import in light of difficulties to conduct on-site GMP inspections due to restrictions linked to the COVID-19 pandemic?

The COVID-19 pandemic has triggered national and international restrictions that may affect and/or prevent the conduct of certain on-site GMP inspections. In light of the severity of the current circumstances, measures should be put in place to ensure availability of GMP certificates and authorisations to manufacture/import to support regulatory submissions, as well as to maintain the validity of current GMP certificates and authorisations to manufacture/import.

This answer also states that, with a view to ensuring the quality of veterinary medicinal products marketed in the EU/EEA, a distinct approach should be taken for sites that are located in the EEA and sites located outside the EEA that have never been inspected by an EEA supervisory authority.

In particular, the validity of GMP certificates for manufacturing sites of active substances and/or finished products located outside the EEA should be extended until the end of 2021 without the need for further action from the holder of the certificate, unless the issuing/supervisory authority takes any action that affects the validity of the certificate. This automatic extension does not cover changes in the scope of the GMP certificate (e.g. new buildings, new medicinal products).

Wherein, for new sites/facilities in third countries where an inspection is required, and where there is no operational mutual recognition agreement (MRA) or the scope is not covered by the MRA, a distant assessment by an EEA supervisory authority may be conducted. A GMP certificate may be granted depending on the outcome of the assessment. In such cases, it should be indicated that the certificate has been granted on the basis of a distant assessment.  Moreover, an on-site inspection should be conducted once circumstances permit.  If the outcome of the distant assessment does not permit the granting of the GMP certificate, a clock-stop will be triggered until an on-site inspection is possible [2].

UNITED KINGDOM

The Medicines and Healthcare Products Regulatory Agency (MHRA) GMDP Inspection Teams work closely with the Veterinary Medicines Directorate (VMD) Inspection Teams to ensure that manufacturers and distributors of veterinary medicinal products are inspected appropriately and to the correct standards.

On 20th March 2020 MHRA announced a risk-based prioritisation of Good Practice inspections due to the COVID-19 outbreak. Until further notice, MHRA will only conduct on-site inspections linked to the UK Government’s COVID19 response or any other potential serious public health risk, and where remote assessment is not possible. Other inspections will be temporarily replaced with alternative regulatory supervision approaches such as office-based assessment [3].

On 3rd April 2020 VMD announced that, as part of their response to coronavirus, they have postponed on-site inspections of veterinary medicines manufacturers, wholesale dealers, veterinary practice premises, SQP retailers, feed businesses and marketing authorisation holders (including pharmacovigilance systems) until further notice.

In the meantime, where possible, VMD will conduct office-based assessments (remote inspections) to assess compliance with the UK Veterinary Medicines Regulations [4].

AUSTRALIA

Following the World Health Organization’s 11 March 2020 declaration of the novel coronavirus (COVID-19) pandemic, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is providing support to holders and manufacturers of veterinary medicines.

The COVID-19 pandemic has resulted in travel restrictions and guidelines for social distancing that have affected the ability to perform GMP inspections in Australia and overseas.

The APVMA’s Manufacturing Quality and Licensing (MQL) Team has developed the guidance “COVID-19: advice for veterinary medicine manufacturers and holders” to allow veterinary manufacturers audited by the APVMA to demonstrate compliance with GMP while social distancing measures and travel restrictions are in place.

This guidance applies during the time that physical audits cannot be carried out due to COVID-19.

In particular, all overseas manufacturers with an audit scheduled before 30 September 2020 will receive an automatic six-month extension to their current GMP compliance letter expiry date.

Wherein, manufacturers with domestic or overseas premises that are not part of a current license or letter of GMP compliance should contact the APVMA to discuss their situation [5].

The article was prepared using data published on official websites of regulatory authorities at the end of May 2020. Given the evolving nature of the COVID-19 situation worldwide, it is not possible to predict accurately when normal business, travel and auditing activities will be able to resume. Therefore, veterinary manufacturers are encouraged to monitor official information and contact regulators if they have questions or issues.

REFERENCES:

  1. EMA / News & events / News and press releases / News: Regulatory flexibility to ensure availability of veterinary medicines during COVID-19 pandemic. URL: https://www.ema.europa.eu/en/news/regulatory-flexibility-ensure-availability-veterinary-medicines-during-covid-19-pandemic (дата обращения 05.2020)
  2. European Commission / Food, Farming, Fisheries / Food Safety / Animals / Animal health / Veterinary Medicines and Medicated Feed / Questions and Answers on regulatory expectations for veterinary medicinal products during the COVID-19 pandemic. URL: https://ec.europa.eu/food/sites/food/files/animals/docs/ah_vet-med_covid-19_qandas.pdf (дата обращения 28.05.2020)
  3. MHRA / MHRA Inspectorate Blog / MHRA Good Practice (GxP) inspections during the COVID19 outbreak. URL: https://mhrainspectorate.blog.gov.uk/2020/03/23/mhra-good-practice-gxp-inspections-during-the-covid19-outbreak/ (дата обращения 28.05.2020)
  4. VMD / Coronavirus (COVID-19) VMD News and Guidance / VMD on-site inspections postponed due to coronavirus (COVID-19). URL: https://www.gov.uk/government/news/all-vmd-inspections-postponed-due-to-coronavirus-covid-19 (дата обращения 28.05.2020)
  5. APVMA / Home / Registrations and permits / Manufacturing / COVID-19: advice for veterinary medicine manufacturers and holders. URL: https://apvma.gov.au/node/65406 (дата обращения 28.05.2020)

 

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