Regulatory/GMP Compliance

Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

A strategy on cyber resilience for health and social care organizations has been set out by the UK government.

FDA has spurred investment to create and develop 600 therapies.

A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Harmonization of global regulations fosters innovation and ensures quality medicines.