Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
These flexibilities will enable manufacturers to:
- release additional quality system capacity for to focus on ensuring continuity of supply using quality risk management principles
- address specific challenges created by international travel restrictions
Related flexibilities on QP (Qualified Person) declarations for active substances, equipment maintenance and calibration, and remote approval of GxP documents have also been published.
The challenges arising from COVID-19 are likely to change. As more information becomes available, we may review previous decisions to ensure they are still valid. They are being regularly reviewed and may be updated at any time.
Manufacture and importation
- Where appropriate based on risk, re-testing of raw materials may be limited to identification only where supplier history, material criticality, and the finished product quality control strategy permits. In these situations, reliance may be placed on the qualified supplier’s certificate of analysis for other quality attributes
- Product may be shipped from a manufacturing site to another suitably authorised site under quarantine whilst quality control tests and batch certification at the manufacturer are ongoing. A system should be in place to ensure that the product is not placed on the market until it has been QP certified
Pharmaceutical Quality System
- Management of non-conformances and incidents after completion of a QA assessment to determine product impact, investigation of ‘minor’ events may be put on hold. These should be tracked, with investigations initiated in response to any identified trend
- Supplier audits may be put on hold. These should be re-prioritised based on risk when travel restrictions are lifted. Manufacturers should consider desk-based assessment for critical materials as an interim measure. Similar principles have been published for QP declarations for active substances
- Routine SOP reviews may be extended
- Internal audit (self-inspection) and GMP refresher training may be put on hold
- Post inspection regulatory commitments relating to deficiencies classified as ‘Other’ may be put on hold. These should be recorded in the quality system and corrected post pandemic
Reporting use of these flexibilities
The Qualified Person should be involved in decisions to implement any GMP flexibilities.
Where flexibilities are used, they should be reported to Covid19.GMDP@mhra.gov.uk.
Read more about reporting use of flexibilities.
Reporting any difficulties to us
If manufacturers find that these measures are not providing enough flexibility to deal with the current logistical challenges quickly, please report this to us as soon as possible.
Reporting any difficulties will help us to monitor the national situation in real time, ensuring we can take actions that support supply chains and address common difficulties as situations change.
We rely upon any difficulties being reported to us quickly, so we can take steps to adjust the regulatory system. This will ensure we can meet the needs of the system and fully support critical supply chains, whilst continuing to protect public health.
Report any difficulties to our Customer Services Centre by calling 020 3080 6000 or email info@mhra.gov.uk.
Further guidance
Last updated 13 July 2020 + show all updates
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Removed information about medicines being marketed outside the UK
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Added link to email address to use to report any difficulties, and a link to reporting the use of regulatory flexibilities.
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First published.