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The comparison between the existing Schedule M and the draft upgraded version (as outlined in the presentation given by Dr Eswara Reddy, JDCI, CDSCO at one of these webinars) would require considerable expenditure and time. These workshops are set to continue over the next few months.
Webinars – Webinars, whether live streamed or on-demand, can be used for communication with HCPs, HCOs, and POs. A company is responsible for the content of webinars and should take reasonable steps to ensure the audience is targeted and well defined.
Some of the biggest changes that GFI #256 brings include: Increased documentation for patient-specific prescriptions Limitations to available 503A office-stock drugs Although veterinary professionals were aware of the impending changes with GFI for months, many have been left scrambling since it went into effect in April.
A Policy & Procedure (P&P) assessment is sent to you to help prepare and organize your documents for submission. Additionally, NABP offers educational resources such as free and low cost webinars on industry topics, blogs , newsletters from the states to their licensees, and weekly and biweekly email newsletters.
Requirements on imports, packaging, storage and circulation of medical products and devices have been eased, while continuing to uphold product requirements for efficacy and patient safety. CROs and sponsors use remote source document verification, as approved by the regulator pre-war.
Gathering transaction information for recalls at the package level. Document the date and the number of relevant full-time equivalent employees (FTEs) for each parent company pharmacy. Conducting product verifications for suspect and illegitimate products. FDA recommends this be based on the November 2024 expected employee filings.
Secondary drying removes adsorbed residual moisture until the target value is achieved, at which point the material is secured in a moisture-free package. Mass spectrometers enable complete documentation of the freeze drying process. Most of the moisture is removed during the primary drying stage. Process gas monitoring.
FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers. Contaminants can come from a drug substance, excipients (a drug’s inactive ingredients), solvents or water used in the process, product degradation during storage, or even in a product’s packaging.
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