ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Offer helpful solutions.

Documentation 52

Documentation Communication 52

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

Documentation 97

Documentation FDA Hospitals Dosage 97

Hospital Pharmacy Europe

JUNE 8, 2023

This suspicion was confirmed in a 2004 analysis by researchers from Oxford. They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents.

Documentation 52

Documentation Communication Patient Care Hospitals 52

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

Hospital Pharmacy Europe

JULY 3, 2024

ED pharmacy services were surveyed for the first time in 2004. The process of safeguarding In healthcare, the initial safeguarding process comprises four stages: recognition, ensuring patient safety, documentation and escalation. So, UK ED pharmacy practice was born.

Hospitals 52

Hospitals Communication Patient Care Packaging 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 October 2004. But it is likely that interpretations in practice refer to footnote 5 from FDA Aseptic Guidance 2004: 7 “A velocity of 0.45 You may unsubscribe from these ISPE communications at any time.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MARCH 7, 2023

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc. March 2004. link] 15 Begley, A. Leave this field blank

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52