The People's Pharmacy

MAY 8, 2023

“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). 24 August 2018. Published 2018. 6 November 2019. 16 February 2022.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. 2018(1):1-10. doi: 10.1155/2018/4391579. Published 2018 Jul 2. Accessed April 2022.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 7 An integrative (vs. 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 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., 16 Health Canada.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

JULY 6, 2023

Vertex continued to invest in CM with two additional approved drugs—Symdeco/Symkevi in 2018 and Trikafta in 2019—with the same indication. Published 24 September 2018. Published 24 January 2018. This is demonstrated by the rise from $1.05 billion US in 2021 to $1.9 Published 24 August 2021. link] 2 a b c d Pagliarulo, N.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

Pharmacy Friday Pearls

AUGUST 29, 2022

2018 Retrospective chart review at a regional poison center (n=199) Patients identified in database by searching for “Beta Blockers”, and/or “Calcium Channel Antagonists” and “insulin” in the respective fields. mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET.

Packaging 52

Packaging Documentation 52

ISPE

SEPTEMBER 10, 2023

In these countries, a secondary packaging site change or an active pharmaceutical ingredient (API) manufacturing site addition triggers a new submission equivalent to that required for approval of a generic drug or a line extension, whereas these site changes may be filed as a notification in the US and EU. Published November 2018.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98