Gmp-compliance.org

  1. Home
  2. Gmp-compliance.org

EMA publishes final Q&A Document on the use of PDE (HBEL) …

Web24-26 September 2024. 1/2 October 2024. In April 2018, the EMA published the final version of the Q&A document on the use of Health-Based Exposure Limits …

Actived: 2 days ago

URL: https://www.gmp-compliance.org/gmp-news/ema-publishes-final-q-a-document-on-the-use-of-pde-hbel-values

FDA Powder Blends and Finished Dosage Units-Stratified in …

WebThis guidance is intended to assist manufacturers of human drug products in meeting the requirements of 21 CFR 211.110 for demonstrating the adequacy of mixing to ensure …

Category:  Health Go Health

MHRA's Interpretation of Cross Contamination & PDEs

WebThe British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where …

Category:  Health Go Health

GMP Question and Answer Guide

WebGMP Question and Answer Guide „GMP Advisor“ – New Version 2.0. – March 2020. Searching for concrete answers to GMP questions is a time-consuming activity. The …

Category:  Health Go Health

EMA website on Permitted Daily Exposure (PDE) limits

WebThe finalisation of the EMA "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared …

Category:  Health Go Health

EMA publishes Q&A on Health Based Exposure Limits

WebIn 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of …

Category:  Medicine Go Health

WHO issues revised Guideline on HVAC Systems

WebThe World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems used for the …

Category:  Health Go Health

FDA Exception from the Requirement to obtain Informed Consent

WebThe rule provides an exception from the requirement to obtain informed consent when a clinical trial poses no more than minimal risk to the people participating …

Category:  Health Go Health

FDA Guidance for Industry: Waiver of In Vivo Bioavailability and

WebThis guidance provides recommendations for sponsors of investigational new drug applications INDs), and applicants that submit new drug applications (NDAs), …

Category:  Health Go Health

Publication of the WHO Document on Limits in Cleaning Validation

Web22/23 May 2024. 1/2 October 2024. 8/9 October 2024. The issue of (cross-) contamination and, in this context, cleaning validation have played an important role in …

Category:  Health Go Health

Can the (√n+1) Rule be accepted in Sampling Plans

WebA sampling plan based on (√n+1) may generally be acceptable, e.g. for a large number of containers. However, such a sampling plan may pose a considerable risk of …

Category:  Health Go Health

WHO Heating, ventilation and air-conditioning systems for non …

WebThese guideline focuses primarily on the design and good manufacturing practices (GMP) requirements for HVAC systems for facilities for the manufacture of solid dosage forms. …

Category:  Health Go Health

FIFO, FEFO, LIFO: What is the meaning

WebFEFO = First Expire First Out. FEFO is to ensure that product with the shortest expiry date is placed into the market first. This makes it possible to reduce business …

Category:  Health Go Health

FDA Guidance for Industry: Sterile Drug Products Produced By …

WebThese FDA guidelines reveal certain methods and procedures which must be taken account of in the aseptic manufacture of sterile medicinal products in order to comply with the …

Category:  Health Go Health

Final WHO Guidance Document on Good Data and Record …

WebWe recently informed you about the WHO Draft Guidance on Good Data and Record Management Practices. Now, the WHO has just released the the final version of …

Category:  Health Go Health

WHO publishes final Guideline for Hold-Time Studies

WebAfter the World Health Organisation (WHO) had released the second draft of the guideline for the design of hold-time studies in March already, it now released the …

Category:  Health Go Health

EU GMP Annex 1: Manufacture of Sterile Medicinal Products

WebSupplementary guidelines to the EC-GMP Guide with specific requirements for the manufacture of sterile medicinal products.

Category:  Health Go Health

What are the regulatory Definitions for "Ambient", "Room …

WebSo, as a resume, terms like "ambient", "room temperature" and "cold chain" should be avoided as the only labelling for storage or transport boxes and containers …

Category:  Health Go Health

Top Categories

 › Appendicitis

 › Headaches

 › Gout

 › Women's Health

 › Thyroid

 › Sleep

 › Skin

 › Sexual Health

 › Senior Health

 › Pregnancy

 › Oral Health

 › Neurology

 › Migraine

 › Mental Health

 › Men's Health

 › Menopause

 › Medications

 › Lung Conditions

 › Infectious Disease

 › HIV/AIDS

Popular Searched

 › Senior health care fayetteville nc

 › Toco regional health authority

 › Palmetto health behavioral care columbia sc

 › Baptist health system wikipedia

 › Mental health advocacy west lothian

 › Simply healthcare florida providers

 › History of baptist health care

 › Baptist health wound care oxygen

 › Baptist health system history

 › Ct county health departments

Recently Searched

 › Home makina health insurance

 › First health moore regional careers

 › Logan health lab tests

 › Health equity in pharmaceuticals

 › Political issues in health care 2023

 › Mental health services boise id

 › East regional health authority outreach

 › Reducing racial inequalities in health

 › Mental health issues in nevada

 › Largest public health insurance companies