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The "Access Consortium", a consortium of the regulatory authorities from Australia (TGA), Canada (HBFB), Switzerland (Swissmedic), Singapore (HSA) and now also the United Kingdom (MHRA), published a three-year plan regarding planned common approaches and goals.

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The International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients.

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The competent authority of Czechia has added a new GPD Non-Compliance Report into the EudraGMDP database. The report states that the company concerned does not provide approved storage facilities and the services of a qualified person are not ensured.

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During various ECA training courses, the question came up who actually issues a GDP certificate and which companies can obtain such a document.

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In August 2021, the MHRA provided information on its website about GMP requirements and most common deficiencies in the area of "transfer of analytical methods".

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Deviations and CAPA are still important issues during inspections. Inspectors' summaries of their observations show that things do not always work as they should. This also applies to root cause investigations.

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Even though the USP has no direct force of law, certainly not in Europe, interesting points for use in risk-based supplier qualification programmes can be found in a newly proposed USP chapter.

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In May 2021, the U.S. FDA issued a Warning Letter to a Turkish over-the-counter (OTC) drug manufacturer called "Gulsah Uretim Kozmetik Sanayi Anonim Sirketi" due to significant violations of cGMP regulations for drug products.

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The United States Food and Drug Administration (FDA) has recently published a Warning Letter sent to an Australian manufacturer of over-the-counter (OTC) drug products. The Warning Letter summarizes significant violations of current good manufacturing practice (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

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In a recently published Warning Letter sent to a Chinese company, the FDA criticises, among other aspects, that analytical test methods were not adequately validated and no system suitability requirements were present.

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