Gmp-compliance.org

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 …

Actived: 4 days ago

URL: https://www.gmp-compliance.org/gmp-news/ema-publishes-q-a-on-health-based-exposure-limits-does-the-1-1000-dose-criterion-come-again-into-play-in-cleaning-validation

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

Web17-19 September 2024. Register now for ECA's GMP Newsletter. In April 2018, the EMA published the final version of the Q&A document on the use of Health …

Category: Health Go Health

Guideline on setting health based exposure limits for use in risk

WebWhen different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern. Medicinal products provide a benefit to the intended patient …

Category: Health Go Health

Shared and Dedicated Facilities: EMA publishes final Guideline on

WebThe EMA has now published the long awaited final version of the Guideline which sets the exposure limits of products manufactured in so-called shared facilities …

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

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

New EMA Guideline on Dedicated Facilities and Exposure Limits …

WebThe draft Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, …

Category: Health Go Health

MHRA's Interpretation of Cross Contamination & PDEs

WebHowever, Health Based Exposure Limits (HBELs) should be determined for all products. If a product is classified as not "highly hazardous", the 1/1,000 dose …

Category: Health Go Health

WHO issues draft Guidance on Best Practices for Clinical Trials

WebBackground and Scope. The document is intended to provide guidance to WHO’s Member States and any staff members of non-State actor organizations whose …

Category: Health Go Health

WHO Guidelines on transfer of technology in pharmaceutical

WebThis document gives guidance in principle and provides general recommendations on the activities necessary to conduct a successful intra- or intersite tranfer of technology …

Category: Health Go Health

WHO Draft Working Document on Good Practices for Quality …

WebEnd of August 2023, the World Health Organization (WHO) has published a draft working document entitled "WHO good practices for pharmaceutical quality control …

Category: Health Go Health

FDA Guidance for Industry: Electronic Source Data in Clinical

WebAfter more than 5 years and two draft versions, the final version of the Guidance for Industry (GfI) - "Electronic Source Data in Clinical Investigations" was …

Category: Health Go Health

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

Publication of the WHO Document on Limits in Cleaning Validation

WebThe aim of the document is to discuss different approaches, including health-based exposure limit values, regarding (cross-) contamination in multi-product facilities. It …

Category: Health Go Health

WHO publishes interesting new Guidance for the Storage and …

WebDuring The 137th World Health Organisation (WHO) Executive Board (EB) meeting, the Report of the 49th meeting of the WHO Expert Committee on Specifications …

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

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

Question and answers on implementation of risk based prevention …

WebThe following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a …

Category: Health Go Health

FDA Updates Guidance on Investigating Out-of

WebThe U.S. Food and Drug Administration (FDA) has published a new version (Revision 1) of its Guidance for Industry on Out-of-Specification (OOS) Results. The …

Category: Food Go Health

PIC/S Aide Memoire

WebPIC/S Aide Memoire - Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management (PI 052-1)

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

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

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