ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. 24 August 2018. Published 2018. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel. Methodology to Define a Pharma 4.0™ It supports the analysis of Industry 4.0 initiatives.

Packaging 52

Packaging Documentation Communication Data Entry 52

The Thyroid Pharmacist

JUNE 14, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! September 27, 2018. 2018;9:511.

Health and Personal Care Stores 109

Health and Personal Care Stores Immunization Documentation Compounding 109

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

JANUARY 8, 2023

Building on these concepts, we provide insights and guidance on how to effectively support the “Human-AI-Team,” a term of the FDA 5 we believe describes very well the target operating model when interacting with AI: in a collaborative manner, complementing the strengths of cognitive as well as AI in GxP-related areas. 12 November 2018.

Communication 52

Communication Documentation FDA 52

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. 10 April 2018. Published 5 April 2018. Big Data Research 24 (15 May 2021): 100172.

Chemotherapy 52

Chemotherapy Dosage Documentation Labelling 52

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

FDA 52

FDA Documentation Communication Hospitals 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage 91

Dosage Documentation FDA Labelling 91

Pharmaceutical Technology

JANUARY 6, 2023

Last week, Novartis announced plans to pay $245 million to end a pay-for-delay legal battle that started in 2018. According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Fighting Entresto generics.

Documentation 97

Documentation FDA Hospitals Dosage 97

The Thyroid Pharmacist

JANUARY 20, 2023

In 1998, the Food and Drug Administration (FDA) defined an adaptogen as a new kind of metabolic regulator that has been proven to help in environmental adaptation and to prevent external harms. Published 2018 Dec 9. doi:10.1155/2018/8198652 [47] Dun Y, Liu S, Zhang W, Xie M, Qiu L. Oxid Med Cell Longev. 2018;2018:8198652.

HIV Treatment and Prevention Agents 96

HIV Treatment and Prevention Agents Immunization Compounding Dosage 96