European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”

Documentation 84

Documentation Pharmaceutical Companies Pharmaceutical Companies 84

Proxsys Rx

DECEMBER 8, 2022

It’s an undertaking that’s simply too large for most hospitals to affordably manage in-house. Another benefit of working with TPAs is that it allows for inventory management to occur virtually. Of all the health systems with 340B programs supported by ProxsysRx, only one manages its entire program in-house without the support of a TPA.

Prescription Filling 52

Prescription Filling Hospitals Documentation 52

The Thyroid Pharmacist

DECEMBER 6, 2023

I have worked with, and surveyed, thousands of other people with Hashimoto’s, and many of them have experienced great improvements in their health via dietary changes. After that change, my stomach was extremely grateful — and my acid reflux disappeared in just three days! What is the right diet to heal Hashimoto’s? I felt happier.

Immunity 97

Immunity Immunization Adverse Reactions Packaging 97

GMPSOP

OCTOBER 28, 2023

If possible, this can eliminate the necessity of quality control processes entirely. Until then, we must rely on quality control processes as part of quality assurance systems. The risk of compromised patient safety for pharmaceutical products outweighs the risk of having no quality control process.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

MARCH 25, 2024

According to the FDA, the general principle of software validation is “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses and that the particular requirements implemented through software can be consistently fulfilled.” Checkout sample preview s.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

GMPSOP

APRIL 19, 2024

As I entered raw data, these spreadsheets processed it and generated useful information. We had to ensure that those Excel spreadsheets were processing GMP data accurately and reproducibly so that our decision did not adversely affect the patient’s health. Why is Excel spreadsheet validation required?

Documentation 52

Documentation Data Entry Communication Pharmaceutical Companies 52

GMPSOP

OCTOBER 26, 2022

According to cGMP, validation in pharmaceutical industry can be defined as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

Putting Patients First Blog

JANUARY 10, 2024

Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, equitable, and sustainable health care.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Diabetes 40

GMPSOP

DECEMBER 10, 2023

Subscribe Regulatory requirements for the control of packaging materials According to US FDA CFR section 211.130, written procedures shall be designed to ensure correct labels, labelling, and packaging materials are used for drug products. (d) Particularly the printed packaging materials where product information is presented.

Packaging 52

Packaging Health and Personal Care Stores Labelling Documentation 52

European Pharmaceutical Review

FEBRUARY 12, 2024

Bringing a therapeutic to market is a long and complex process. Extensive upstream and downstream development is needed to achieve robustness of the commercial manufacturing process, make the drug product at scale and deliver on consistent product quality. Understandably, this process is tightly controlled and highly standardised.

Process Improvement 88

Process Improvement Packaging 88

European Pharmaceutical Review

NOVEMBER 9, 2022

An integrated vector supply, however, can help manage uncontrollable external factors by limiting supply chain uncertainty and allowing companies to respond in a more agile manner to challenges as they arise. The fact that vector processes are also more difficult to scale up, requiring high-grade facilities and highly specialised personnel.

Vaccines 95

Vaccines Documentation Communication Hospitals 95

The Thyroid Pharmacist

JULY 7, 2023

They can be elevated for as many as 10-15 years before a change in TSH is even detected. [1] In Part 1 of this article, How to Reduce Thyroid Antibodies , I discussed why thyroid antibodies are so important as an early warning for Hashimoto’s, what their significance is in Hashimoto’s, how to test for them, and how to properly monitor them.

Immunity 104

Immunity Immunization Diabetes Dosage 104

The Thyroid Pharmacist

JANUARY 13, 2023

They help establish your stress tolerance, tame inflammation, regulate blood sugar and body fat, control potassium and sodium levels (impacting blood sugar), and influence sex drive and anti-aging… among other things. [1]. Many symptoms of hypothyroidism overlap with symptoms of underactive adrenals. What causes adrenal dysfunction?

Health and Personal Care Stores 98

Health and Personal Care Stores Diabetes Communication Dosage 98

The Thyroid Pharmacist

MARCH 10, 2023

Sleep deprivation is an important root cause or exacerbating factor for various health conditions — and it’s also all-too-common in our modern world. For some people, prioritizing sleep is the biggest hurdle, but others may struggle with sleep despite their best efforts, due to physiological factors. Even with 11 hours of sleep, I was always tired.

Health and Personal Care Stores 68

Health and Personal Care Stores Immunity Immunization Dosage 68

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). The letter is signed by six former DEA administrators and five former Directors of National Drug Policy. There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. By Larry K.

Controlled Substances 59

Controlled Substances Chemotherapy Compounding 59