Exceptional GMP Flexibilities for Medicines Manufacturers during the corona virus (COVID-19)

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

Manufacture and importation

Where appropriate based on risk, 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.

Based supplier history, material criticality, and the finished product quality control strategy permits, material shall be released based on supplier certificate of analysis & quality risk assessment.

For Raw materials and Packing materials where outside testing is applicable and not able to perform due to transportation restriction results of analysis of last consignments received shall be checked and material will be released based on in-house test results and release data of vendor.

Testing results for parameters applicable for outside testing shall be taken from Vendor COA and Vendor should be approved vendor.

The analysis of pending in-house tests shall be completed before QP release of the particular batch

Product may be shipped from a manufacturing site under quarantine whilst quality control tests and batch certification at manufacturer are ongoing with system in place to ensure that the product is not placed on the market until it has been QP certified.

In such case batch can be released under quarantine for dispatch as per the market requirement and Certificate of conformance (COC) will be issued after completion of all materials and Finished Product testing.

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 and these should be tracked, with investigations initiated in response to any identified trend.

Supplier audits may be put on hold and these should be re-prioritized based on risk when travel restrictions are lifted.

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 and 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 reportedto Covid19.GMDP@mhra.gov.uk.

Medicines being marketed outside the UK

If the medicine might also be marketed outside the UK, and/or if the manufacturer is operating under a manufacturing authorization granted by another medicines competent authority, the report must also be sent to the competent authority of the relevant market.

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 Medicines and Healthcare Products Regulatory Agency (MHRA) UK as soon as possible.

Reporting any difficulties will help MHRA UK to monitor the national situation in real time, ensuring MHRA can take actions that support supply chains and address common difficulties as situations change.

MHRA rely upon any difficulties being reported and can take quick steps to adjust the regulatory system.

This will ensure MHRA can meet the needs of the system and fully support critical supply chains, whilst continuing to protect public health.

Report any difficulties to MHRA Customer Services Centre by calling 020 3080 6000 or email info@mhra.gov.uk.

Reference : https://www.gov.uk/guidance/exceptional-gmp-flexibilities-for-medicines-manufacturers-during-the-coronavirus-covid-19-outbreak


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