GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Proxsys Rx

APRIL 19, 2024

And that is why the one 340B prediction we can make for 2024, unequivocally, is repeated three times in this post’s headline. Which means we may see a lot more states putting manufacturers in their place, in 2024. How covered entities should prepare for 340B changes in 2024 Build a qualified 340B team. And More Change.

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Specialty Pharmacies Hospitals Drug Pricing Packaging 52

Big Molecule Watch

JANUARY 5, 2024

Regeneron seeks a PI schedule to “ensure an orderly process that will result in resolution of its forthcoming motion for PI before May 17, 2024,” when its regulatory exclusivity period ends. The proposed schedule also provides dates for document discovery and depositions. Specifically, Regeneron has asserted the following patents.

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Packaging Biosimilars Documentation 49

National Association of Boards of Pharmacy

OCTOBER 23, 2024

Full enforcement of the  Drug Supply Chain Security Act  (DSCSA) was set to begin on November 27, 2024, at the conclusion of the one-year FDA Stabilization Period. On October 10, 2024, U.S. Food & Drug Administration (FDA) issued an exemption notice for certain DSCSA requirements. We support this decision.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement.

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Labelling Packaging Documentation 59

Quality Matters

NOVEMBER 5, 2024

API DMFs are documents containing information on APIs that are submitted to the U.S. Food and Drug Administration (FDA) by API manufacturers to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

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Pharmaceutical Manufacturing Packaging Documentation 78

National Association of Boards of Pharmacy

JULY 19, 2024

On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026. Gathering transaction information for recalls at the package level.

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European Pharmaceutical Review

JANUARY 13, 2025

5 However, the benefits are well documented. Sustainable pharma packaging: breaking down the barriers to adoption Over two years it resulted in approximately 52,000 inhalers being returned, equating to approximately 305 tonnes of CO 2. 2024; 85: 1-9. Pulmonary Pharmacology & Therapeutics. Internet] The Aerosol Society.

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Packaging Community Pharmacies Documentation Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Despite the removal of some of the most controversial proposals, the final rule still contains a variety of significant changes, which become effective on November 19, 2024. The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g.,

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Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. Eric Halioua: We forecast to get the final report of the current clinical trial (P-I/II PDC-LUNG-101 trial) in Q2 2024. Smriti: Please share the development timeline for the PDC*lung01, when can we expect the next phase of development?

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Immunization Immunity Vaccines Health and Personal Care Stores 40

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Intensive care medicine , 33 (11), 2019–2024. Greene et al., Potassium was maintained within low normal range (3.8-4.0

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Packaging Documentation 52

Express Pharma

DECEMBER 23, 2024

On December 15, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 11 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Good Practices In Quality Control. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation.

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FDA Law Blog: Biosimilars

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

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Documentation Packaging Clinical Pharmacology Drug Development 59