# Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/d0f0801c-f6f4-4c40-9a0e-9a1e91d6ab65
Type: Detailed Guide
Published: April 22, 2020
Updated: July 13, 2020

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance outlining temporary flexibilities in Good Manufacturing Practice (GMP) to maintain medicine supplies during the COVID-19 pandemic. This framework allows manufacturers and importers to focus resources on supply continuity by using quality risk management principles to address challenges like international travel restrictions. Key flexibilities include limiting raw material re-testing to identification only, shipping products under quarantine while testing is completed, and deferring 'minor' incident investigations. Additionally, companies may put supplier audits, internal inspections, and routine training on hold, and extend timelines for procedure reviews. Manufacturers must ensure a Qualified Person (QP) is involved in all decisions to implement these measures. Required actions include reporting the use of these flexibilities to the MHRA via email and documenting all postponed activities within the company quality system for correction after the pandemic. The MHRA will regularly review these decisions as the public health situation evolves to ensure they remain appropriate.

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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 Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak