Quality Matters

NOVEMBER 27, 2023

While the FDA has not yet received reports of eye infections associated with these 29 products, the agency published a draft guidance in October 2023 titled “ Quality Considerations for Topical Ophthalmic Drug Products ,” marking the first instance of the FDA providing specific guidance for this product category.

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epicur

DECEMBER 19, 2022

The FDA recently finalized regulatory guidance for compounded animal medications from bulk drug substances for use in non-food-producing animals, impacting the way compounded drugs can be used, documented, ordered, and prescribed. Pharmacists must document why an FDA-approved or indexed product is not being used to compound the medication.

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GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. All written and updated by GMP experts.

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Integra X Files

DECEMBER 19, 2022

The guidance goes on to delineate formulary provisions to ensure that Medicare enrollees in nursing homes are not disadvantaged by the nonavailability of dosage forms that are commonly required in the nursing home environment. The major LTC pharmacy GPOs have organized pharmacy networks to negotiate on behalf of their members.

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GMPSOP

JUNE 16, 2023

Importance of acceptance criteria in analytical method transfer Pharmaceuticals quality assurance & validation procedures GMPSOP Importance of acceptance criteria in analytical method transfer Last modified: June 17, 2023 Table of Contents What is analytical method transfer? Additional documents included each month. Subscribe b.

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Pharmaceutical Technology

NOVEMBER 3, 2022

The Australian Department of Health and Aged Care published a similar statement on August 25, stating that tenecteplase shortages will likely affect the country until the end of 2023. In the US, news reports of the heart failure drug dobutamine in short supply appeared earlier this year. Extending the shelf-life is also a consideration.

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GMPSOP

SEPTEMBER 27, 2023

Cleaning validation protocol for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Cleaning validation protocol for pharmaceutical industry Last Updated on September 28, 2023 by Kazi Prev PREVIOUS POST Table of Contents What is cleaning validation in pharmaceutical industry?

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Quality Matters

JUNE 6, 2023

To help ensure suppliers meet the necessary standards for producing high-quality excipients, such evaluations should also include an assessment of the supplier's facilities, personnel, documentation, and quality control procedures. kristine.gates… Tue, 06/06/2023 - 17:00 Supply Chain

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Quality Matters

JUNE 14, 2023

Beyond addressing proper documentation, storage, and transportation, GDPs incorporate appropriate mitigation strategies to control the foreseeable risks. Out of the 550+ reported counterfeiting incidents, either customs seizures or police/health inspector raids were involved, and 60% of the seizures comprised more than 1,000 dosage units.

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The Thyroid Pharmacist

JULY 14, 2023

2] In some cases, the person will become hyperthyroid, and the dosage of their medications will need to be reduced. If they are already taking thyroid medications, they may find themselves overmedicated, and may need to work with their doctors to reduce their dosage of thyroid medications. Accessed May 25, 2023. doi:10.1089/thy.2010.0102;

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The Thyroid Pharmacist

DECEMBER 1, 2023

10] In Finland, the incidence of type 1 diabetes in Finnish children increased when the daily recommended dosage of vitamin D was reduced from 4000-5000 IU in 1964, to 400 IU in 1992. Vitamin D deficiency has been documented in Hashimoto’s, Graves’ disease, thyroid cancer, as well as postpartum thyroiditis. [13] Published 2021 Oct 9.

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Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug.

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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.

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The Thyroid Pharmacist

JANUARY 20, 2023

I recommend that you closely monitor your thyroid symptoms, thyroid hormones, and thyroid antibodies, and test hormone levels every six to 12 weeks, to ensure your thyroid medication dosage is optimized. This is a great idea for any lifestyle intervention, but a must for lifestyle changes that could impact your TSH.)

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