WHO Guidelines on transfer of technology in pharmaceutical manufacturing
This document gives guidance in principle and provides general recommendations on the activities necessary to conduct a successful intra- or intersite tranfer of technology (analytical transfer is also adressed). API and finished dosage forms are covered.
FDA Guidance for Industry: Non-Penicillin Beta-Lactam Drugs:
A CGMP Framework for Preventing Cross-Contamination
This guidance describes the importance of implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam antibiotics.
FDA Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination
EU/51/2013 Decision on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities
Commission Implementing Decision of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council
FDA Guidance for Industry: Completeness Assessment for Type II API DMFs unter GDUFA
This draft guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA) or an amendment or prior approval supplement (PAS) to an ANDA (generic drug submissions)