Pharmaceutical artwork is a highly regulated process, involving different regulations for multiple product portfolios. Despite the stringent regulations surrounding pharmaceutical packaging, artwork-related errors still exist and the potential for these errors is relatively high when the company relies solely on manual processes.
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June 16, 2021 Pharmaceutical, Regulatory Artwork Services -
May 19, 2021 Pharmaceutical, Regulatory LabelingThe Therapeutic Goods Administration (TGA) of Australia has published guidance on TGO 91 and 92 on March 23, 2021 in order to assist sponsors and producers of medicines in complying with the Australian latest labeling standards.
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May 11, 2021 Pharmaceutical, Regulatory AffairsGxPs are standardized practices defined for drug companies that research, produce, store, distribute or sell pharmaceutical products. GxPs refer to a collection of quality standards and guidelines that are designed to ensure that the safety of the products is maintained across the product lifecycle.
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March 30, 2021 Pharmaceutical, Regulatory AffairsANVISA of Brazil received the approval to become a member of PIC/s (Pharmaceutical Inspection Co-operation Scheme) in November 2020. Considering the pandemic situation, for the first time in PIC/s history, the assessment was completed in a written procedure as opposed to at a meeting; on Jan 1, 2021, the PIC/s committee welcomed ANVISA as their 54th valuable member.
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February 9, 2021 Pharmaceutical, Medical Devices, Food and Food Supplements, Chemicals, Consumer Healthcare, Regulatory AffairsThe year 2020 has been unpredictable for all the industries across the globe, including life sciences industry. With the outbreak of COVID-19, the life sciences industry and global Health Authorities faced various challenging scenarios, which in turn affected their long-term Regulatory plans.
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The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic.
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February 3, 2021 Pharmaceutical, Regulatory AffairsDuring unexpected emergencies, like COVID-19, conducting on-site pharmacovigilance (PV) inspections are not feasible due to travelling difficulties, orders from local authorities, and restrictions to accessing facilities justified by health hazards. Under such conditions, remote inspections would become the most preferable, replacing on-site inspections.
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December 3, 2020 Pharmaceutical, Regulatory AffairsThe NPRA Malaysia has updated, “Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration” - Version 5.0 (June 2020). The guidance helps API manufacturers to expedite the registration process. Further to this update, a temporary notice on mode of DMF submission has also been provided as below.
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October 13, 2020 Pharmaceutical, Regulatory AffairsAs it is quite inevitable that the transition period for the Brexit is not going to extend, numerous Regulatory changes or updates are expected to emerge from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the same context, MHRA has recently issued a guidance on pharmacovigilance procedures and post transition requirements for Qualified Person Responsible for Pharm
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October 8, 2020 Pharmaceutical, Regulatory AffairsIt is a known fact that the UK has officially left the European Union (EU) on January 31, 2020 and it is in the transition period until December 31, 2020. During the transition period, all the pharmaceutical companies in the UK must abide by the EU pharmaceutical law.