The pharmaceutical industry is one of the most strictly controlled and regulated industries. Hardly any other industry has such strict requirements for documentation and archiving of information and records. In 2022, even more extensive regulatory measures will be added, which will not only affect the manufacturing and quality management process, but also lead to increased verification and documentation efforts.
Nitrosamine scandal: fast and reliable access to archived documents as a competitive advantage
The debate about nitrosamines in medicines has kept the pharmaceutical industry on its toes since 2018. Nitrosamines are found in a number of foods such as beer, fish products and meat products preserved with nitrite pickling salt. But in 2018, the mutagenic N-nitrosodimethylamine was discovered as an impurity in the active medical ingredient Valsartan from the manufacturer Zhejiang Huahai Pharmaceutical. This was followed not only by the recall of all batches of Valsartan, but also by a series of regulatory actions by the European Medicines Agency (EMA) and other government agencies. As a result, pharmaceutical companies had to, and still have to, review their manufacturing processes for the affected products in several steps. In step 1 ("Call for Review"), they were asked to prepare a risk assessment on possible nitrosamine contamination. Those who could quickly access not only digital documents, but also archived physical documentation, had a decisive time advantage and a corresponding competitive edge. Hybrid archives, consisting of a total solution of digital, virtual archives and external outsourcing to the highest security standards, emerged as the most efficient solution for collecting all documents. If the analysis reveals a risk, the pharmaceutical companies involved can quickly proceed to phase 2 ("confirmatory testing"). This test should confirm or negate a contamination. In the case of a confirmed nitrosamine contamination, risk mitigation measures must be implemented and a notification of change (Variation) has to be submitted.
The deadlines for the risk assessment already expired in 2021. In the year 2022 and 2023 the deadlines for the confirmatory examination will follow:
- 26th of September 2022 for medicines with chemically synthesised active substances.
- 1st of July 2023 for biological medicinal products
Here too, reliable, complete and verifiable access to all relevant documents will be crucial.
Manufacture of sterile medical devices: new rules
In addition, further GMP-relevant changes and the associated documentation/archiving are expected in the coming months. These include, for example, the revision of the so-called Annex 1 of the GMP Guide "Manufacture of Sterile Medicines". This is considered the essential regulation for the manufacture of sterile medical products. The most far-reaching reform since the introduction of the guideline will also have consequences for the digital and physical archiving of relevant information and accompanying documents. For example, changes are expected in the areas of quality risk management, process and environmental monitoring, and related documentation.
The manufacture and documentation of veterinary medicinal products will also be changed in 2022. The PIC/S working group on veterinary medicinal products and a working group of GMP/GDP inspectors from the EMA have jointly prepared two concept notes on the review of the manufacture of immunological/non-immunological veterinary medicinal products at the end of 2021. These will be subject to public consultation in early 2022 and will lead to regulatory changes in the following months.
In a dynamic and at the same time highly regulated market environment such as the pharmaceutical industry, information security and efficient, reliable access to digital and physically stored information are essential in order to be able to react quickly to changing framework conditions, audits and revisions.
Read more about how to get efficient, reliable access to your digital and physically stored information as a pharmaceutical company here!
