ISPE

NOVEMBER 2, 2022

ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.

Documentation 52

Documentation Compounding Communication FDA 52

ISPE

JULY 21, 2023

ICH Q9 states: “The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.” There is an increased emphasis in ICH Q9 (R1) on managing product availability risks related to manufacturing problems/issues.

Documentation 98

Documentation 98

Omnicell

JANUARY 10, 2023

2003: Congress passed the Medicare Modernization Act (MMA), which included the creation of the Medicare Part D program. The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise.

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

Druggist

FEBRUARY 17, 2021

Insect venoms (wasps) contain several allergens, which cause unpleasant symptoms, and in some cases, may cause an anaphylactic reaction (Moffitt, 2003). The mechanism action of local anaesthetic creams is well defined, and their effectiveness well documented. 2003 Nov;96(11):1073-9. Sting bites: Do I need to see a GP?

Compounding 98

Compounding Documentation Labelling 98

Roots Analysis

JANUARY 3, 2024

By the end of the 20th century, there was a well-documented history of cosmetic procedures such as eyelid surgery, facial lifts, breast implants and augments, hair transplants, fat reduction, and skin resurfacing. However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002.

Hospitals 40

Hospitals Documentation FDA 40

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JULY 20, 2023

SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring. Cited 2023Mar].

Labelling 75

Labelling Documentation Hospitals 75

Druggist

SEPTEMBER 7, 2020

However, it has been documented that when used regularly, tolerance develops rapidly (Vande Griend, Anderson, 2003), within a few days of starting the treatment. doi:10.1101/cshperspect.a020412 Available at: [link] Accessed on 03/09/2020 Vande Griend, Anderson (2003). Cold Spring Harb Perspect Biol. 2015;7(1):a020412.

Documentation 94

Documentation 94

ISPE

JULY 10, 2023

In this constructive process, documentation regarding the decisions made are important to justify the model and explain-ability mechanism selection in an audit context.” Journal of Machine Learning Research 3 (2003): 1137–55. ChatGPT : “The solution should be made to meet its desired quality standards. “An The Keyword. Subbiah, J.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 This was followed in September 2022 by the publication of the PIC/S’s identical Annex 1. m/s up to 0.54

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Published 2003. The assessment may also identify perception concerns. Biological (Viral and Microbial) Risk Progression. European Commission.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 5 (2003): 395–413. doi:10.23919/INM.2017.7987376 2017.7987376 12 Jansen-Vullers, M.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

MARCH 7, 2023

“Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Published 6 February 2003. Published 6 February 2003. 27 January 2022. EMA/CHMP/QWP/545525/2017 Rev. ICH Harmonised Tripartite Guideline Q1E: Evaluation for Stability Data.”

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52