Quality Matters

JUNE 21, 2023

LMICs need more resources for post-marketing surveillance Low- and middle-income countries (LMICs) often encounter numerous hurdles in effectively executing post-marketing surveillance programs. FDA and USP in Rockville, Maryland. The panel was titled “Securing the Downstream Supply Chain: Post-marketing Surveillance.”

Communication 52

Communication Vaccines Documentation 52

GMPSOP

AUGUST 23, 2022

240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Quality risk management can be useful in determination of the scope and extent of commissioning, qualification and validation activities for systems and production processes in good manufacturing practice. How to apply quality risk management in validation?

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. How do you do it? To confirm your test results are trustworthy and unbiased, you would turn to well-designed policies, procedures, guidelines, methods, protocols and all types of records.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

GMPSOP

MARCH 25, 2024

Validation Team: The validation team is responsible for establishing and maintaining computer validation programs, developing and approving computer validation policies, plans, protocols, and reports, and completing verification testing of all computer validation activities in compliance with regulatory and GAMP guidelines.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

GMPSOP

APRIL 19, 2024

Guideline for Excel spreadsheet validation Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Excel spreadsheet validation involves developing and testing spreadsheet applications and confirming that the information generated through the spreadsheet is accurate, complete, intended, and reproducible.

Documentation 52

Documentation Data Entry Communication Pharmaceutical Companies 52

pharmaphorum

JULY 29, 2021

It’s estimated specialty medications account for 75% of the approximately 7,000 prescription drugs currently in development, and by 2022, more than 60% of the 600 drugs expected to gain FDA approval will be specialty medications. The challenge is, drugs in this category are often difficult to administer and very costly.

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Specialty Pharmacies Drug Pricing 111

GMPSOP

DECEMBER 28, 2022

You have to develop plans, policies, protocols and equipment to monitor your controlled environments appropriate for the use of that environment for pharmaceutical productions. Table of Contents What is meant by environmental monitoring? The program includes a corrective action plan when action levels are exceeded.

Documentation 52

Documentation Vaccines 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

European Pharmaceutical Review

OCTOBER 27, 2022

These new findings present an extremely optimistic outlook for biologics manufacturing and CMOs as the industry prepares for a near record event at CPHI Frankfurt and BioProduction, with pre-pandemic numbers of pharma executives expected to attend.

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Biosimilars Vaccines Drug Development 75

Pharma Marketing Network

JUNE 8, 2020

Good morning, Dave. Thanks for coming on the podcast and if you wouldn’t mind, could tell us a little bit about yourself. Dave (HR): Sure. Thanks for having me on. Quick background on myself. It’s probably approaching a three-billion-dollar business. Dave (HR): Yeah, I actually have a chapter in my book on this.

Health and Personal Care Stores 40

Health and Personal Care Stores Mayo Clinic Hospitals Specialty Pharmacies 40