[Stability Testing related News – vol.52]

◆  MHRA starts combined Distant / On-Site Inspections (31-Mar-21 ECA)

Like other surveillance authorities, the UK Medicines and Healthcare products Regulatory Agency MHRA had suspended its on-site GxP inspection programme in the wake of the pandemic and related restrictions.

Now, domestic on-site inspections are to be carried out again from 29 March 2021. For this purpose, a combination of remote and on-site inspection approaches will be used after appropriate risk assessment. In doing so, the MHRA wishes to reduce the regulatory burden on businesses as much as possible during the COVID 19 pandemic, but stresses that this should “not impact on the Agency’s regulatory powers to inspect”.

The MHRA now outlines the expectations to be considered during on-site inspections and their preparation, taking into account current government guidance on minimising risk to personal safety. MHRA will continue to prioritise inspections with relevance to pandemic response or with potential serious risks to public health.

What are the key points of the Guidance?

  • Inspections are usually announced 14 days in advance (justified exceptions are possible),
  • Discussion of risk assessment, logistics and potential difficulties between the lead inspector and the inspected site thereafter,
  • Determine what can be assessed remotely and how. For this purpose, as much documentation as possible is requested in advance; part of it is checked off-site, if necessary by remote access to necessary information,
  • Sufficient staff should be available (remotely if necessary) to facilitate the inspection,
  • A dedicated work area is needed on site that allows for social distancing. Site visits are discussed in advance,
  • Attendance at face-to-face opening and closing meetings and necessary inspection interviews will be kept to a minimum,
  • Interviews are scheduled for longer periods of time if possible and can also take place via video conferencing, Interviews needed at short notice can also take place via telephone or other technologies,
  • Minimising the number of staff accompanying site visits,
  • On-site provision of documents by electronic means is also preferred (use of MHRA laptops).


◆  Supplier Qualification for Packaging Material (07-Apr-21 ECA)

USP´s Packaging and Distribution Joint Subcommittee posted a proposal for the development of a new General Chapter <1xxx> Supplier Qualifications. The Joint Subcommittee will make recommendations to the General Chapters (GC) Packaging and Distribution Expert Committee who will be responsible for this new standard. The input deadline is 25 April 2021. The final proposal is expected to be published for comment in Pharmacopeial Forum (PF) 47(5) [September / October 2021].

Supplier qualification based on risk management and technical agreements

The various sources for packaging material include external, local, and global suppliers. External suppliers frequently also provide additional services such as assembly, analysis, packaging, warehousing, transportation, distribution, etc. This means that packaging components used in the final product have to be manufactured according to the appropriate (GMP-) standards. It also means that the processes in the supply chain for a material or service have to comply with relevant regulations and (GDP-) requirements (if applicable).

According to the USP pharmaceutical manufacturers should have processes in place to systematically evaluate packaging suppliers based on

  • The risk to the quality of the material or service supplied,
  • Compliance of the quality systems to relevant regulations and (GMP / GDP-) requirements, if applicable,
  • The reliability of the supplier to avoid quality deviations and shortages of packaging components and / or materials,
  • A supply contract or quality agreement.

The approach includes the identification and selection, evaluation and acceptance, performance monitoring, and disqualification of packaging material suppliers (e.g., primary, secondary, ancillary and shipping packaging), and service providers (e.g., logistic providers for warehousing and transportation, analytical services).

More information can be found in USP´s announcement for the new General Chapter  <1xxx> Supplier Qualifications.

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