FDA Law Blog

NOVEMBER 30, 2022

The purpose of the PAI was to determine whether the facility has a quality system that was designed to achieve sufficient control over the facility and commercial manufacturing operations and evaluate the facility’s Good Manufacturing Practice (GMP) compliance.

FDA Approval 72

FDA Approval Manufacturing Compliance Contamination 72

FDA Law Blog

OCTOBER 31, 2021

Under SB 343, a product or packaging is not recyclable in California if: It includes components, inks, dyes, adhesives, or labels that prevent its recyclability; It contains intentionally added chemicals identified pursuant to regulations implementing section 42370.2(g)(4) g)(4) of the California Public Resources Code; or.

Packaging 52

Packaging Packaging Containment Production 52

FDA Law Blog

JULY 18, 2023

Table: Inventory Shift Over FY2018-FY2022 for Countries (Greater Than 50 Sites) Drug Products In addition to a catalog of manufacturing sites, OPQ reports that CDER also keeps a drug product catalog that contains over 140,000 entries. CGMP deviations caused 56 recalls, and excipient manufacturers performed 51 recalls due to contamination.

Manufacturing 52

Manufacturing Production Contamination Drugs 52

Roots Analysis

MAY 24, 2024

They are generally used in combination with primary containers, such as prefilled syringes and cartridges. These autoinjectors offer several advantages, including simplified drug administration process, safer injection, reduced risk of contamination and minimized maintenance ( due to elimination of cleaning and sterilization steps ).

Drug Delivery 40

Drug Delivery Containment Contamination Production 40

FDA Law Blog

NOVEMBER 9, 2023

food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. As a result, FDA cannot monitor, locate, inspect, and if needed, contain any shipment that has been identified as a possible public health or bioterrorism risk.

Regulation 52

Regulation Compliance Contamination Containment 52

FDA Law Blog

NOVEMBER 22, 2022

coli contamination. On November 15, as part of the Agency’s implementation of the Food Safety and Modernization Act (FSMA), FDA released the f ood traceability final rule , which aims to reduce the occurrence of foodborne illnesses by enabling FDA to more efficiently identify and remove potentially contaminated food from the market.

Contamination 52

Contamination Production Manufacturing Packaging 52

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. However, this needle system does not contain a proper locking system, therefore, increased the chances of leakage.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

Advarra

MARCH 31, 2023

This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.

Engineer 52

Engineer Genetics Clinical Research Research 52

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Summaries of the most striking recently released Warning Letters are included below. Dextrum Laboratories Inc.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

The Pharma Data

APRIL 27, 2022

In particular, Action Levels for Lead in Juice: Draft Guidance for Industry , provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice.

Cosmetics 52

Cosmetics Production Containment Contamination 52

The Pharma Data

FEBRUARY 18, 2022

The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. Each module is built of six ISO sized containers (2.6m The first BioNTainer is expected to arrive in Africa in the second half of 2022.

Manufacturing 40

Manufacturing Vaccination Vaccine Production 40

Roots Analysis

FEBRUARY 1, 2024

It is worth highlighting, in 2021, TempAid, a cold chain industry offering temperature controlled packaging products, announced the introduction of the first biodegradable shipping container. These containers are available in a single use, as well as reusable format.

Packaging 40

Packaging Packaging Containment Production 40

The Pharma Data

NOVEMBER 18, 2020

Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes. and improve public health.

Regulation 52

Regulation Compliance Contamination Marketing 52

Roots Analysis

SEPTEMBER 20, 2023

However, there are several hurdles associated with the transition of cell-based therapy products from laboratory to clinical scale, such as regulatory compliance, lack of advanced facilities and infrastructure. Such procedures require sterile and higher-grade clean rooms, along with regular checks on containment levels.

Manufacturing 40

Manufacturing Production Contamination Gene Therapy 40

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms. More information is available at www.athersys.com. Forward-Looking Statements.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

Pharmaceutical Technology

JUNE 14, 2023

This, coupled with small pharma companies being unable to acquire or access containment capabilities in-house, means that the demand for innovative specialized small molecule capabilities remains high. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130

XTalks

JANUARY 28, 2025

link] New Product Introduction (NPI) and Technical Transfer (TT) As drug products containing highly potent APIs (HPAPIs) become more prevalent, a robust approach to TT and NPI is essential. The lack of standardized guidelines for NPI and TT further complicates these tasks, making meticulous planning and robust process controls essential.

Manufacturing 52

Manufacturing Development Contamination Production 52