The pharmaceutical industry is one of the most strictly controlled and regulated sectors. Few other industries are subject to such stringent requirements for the documentation and archiving of information and records. In 2022, even more extensive regulatory measures have been introduced, impacting not only manufacturing and quality management processes, but also leading to increased verification and documentation requirements.
Nitrosamine Scandal: Fast and Reliable Access to Archived Documents as a Competitive Advantage
The debate surrounding nitrosamines in medicines has kept the pharmaceutical industry on high alert since 2018. Nitrosamines are present in certain foods such as beer, fish products, and meat products preserved with nitrite curing salt. However, in 2018, the mutagenic N-nitrosodimethylamine was discovered as an impurity in the active pharmaceutical ingredient Valsartan, produced by Zhejiang Huahai Pharmaceutical. This discovery prompted not only the recall of all affected batches of Valsartan, but also a series of regulatory actions by the European Medicines Agency (EMA) and other regulatory authorities.
As a result, pharmaceutical companies have had to, and continue to, review their manufacturing processes for the affected products in several phases. In Phase 1 ("Call for Review"), companies were required to prepare a risk assessment for potential nitrosamine contamination. Those with rapid access to both digital and archived physical documentation had a significant time advantage—and a corresponding competitive edge. Hybrid archives, comprising a total solution of digital and virtual repositories, combined with external archiving under the highest security standards, have proven to be the most efficient way to consolidate all relevant documents.
If a risk is identified through analysis, the pharmaceutical company can swiftly proceed to Phase 2 ("Confirmatory Testing"). This stage is intended to confirm or rule out contamination. If nitrosamine contamination is confirmed, risk mitigation measures must be implemented and a Variation (notification of change) must be submitted.
Deadlines for the risk assessments expired in 2021. The deadlines for confirmatory testing follow in 2022 and 2023:
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26th September 2022 for medicines with chemically synthesised active substances
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1st July 2023 for biological medicinal products
In these phases as well, reliable, complete, and verifiable access to all relevant documentation remains crucial.
Manufacture of Sterile Medical Devices: New Rule
Further GMP-relevant changes, including associated documentation and archiving requirements, are expected in the coming months. Among these is the revision of Annex 1 of the GMP Guide, "Manufacture of Sterile Medicinal Products"—a key regulation for sterile medicine production. The most significant reform since the guideline's inception will also affect the digital and physical archiving of relevant information and supporting documentation. Expected changes include updated requirements in areas such as quality risk management, process and environmental monitoring, and related documentation.
The manufacture and documentation of veterinary medicinal products are also being revised in 2022. The PIC/S working group on veterinary medicinal products and a GMP/GDP inspector working group from the EMA jointly prepared two concept papers at the end of 2021. These entered public consultation in early 2022 and are expected to lead to regulatory changes in the months ahead.
In a dynamic and heavily regulated market such as the pharmaceutical industry, information security and efficient, reliable access to both digital and physical data are essential for timely responses to evolving regulatory frameworks, audits, and inspections.
Read more about how your pharmaceutical company can ensure efficient, reliable access to both digital and physical information here!
Lees hier meer over hoe u een efficiënte, betrouwbare toegang tot uw digitale en fysiek opgeslagen informatie kan krijgen als farmaceutisch bedrijf!
