Skip to main content Skip to search Skip to main navigation

What does reprocessing mean in the production of APIs?

Where the issue at hand here is only repetition of a process step that is part of the routine process and thus of the master batch record, the term used is reprocessing. Examples of reprocessing include repetitions of crystallisation, distillation, filtration, chromatography or milling.

[GMP Compliance Adviser, Chapter 20.A]

Would you like to discover more?

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

ICH: Updated Q9(R1) Briefing Pack

ICH: Updated Q9(R1) Briefing Pack

The ICH has fully revised the Q9(R1) Briefing Pack (March/April 2026) to align with the updated ICH Q9 guideline.
Read more
EMA: New Plans for the EU GMP Guide

EMA: New Plans for the EU GMP Guide

EMA published the GMDP Inspectors Working Group’s new 2026-2028 work plan and its 2025 annual report.
Read more
EMA: Pharmaceutical Quality System (PQS) Effectiveness Pilot Project

EMA: Pharmaceutical Quality System (PQS) Effectiveness Pilot Project

EMA launched a pilot under which EEA GMP inspectors will assess how sites demonstrate the effectiveness of their pharmaceutical quality system for risk-based change management, and whether the EEA GMP certificate could serve as the main evidence of this effectiveness.
Read more
EMA: Updated Guideline on Active Substance Chemistry

EMA: Updated Guideline on Active Substance Chemistry

The EMA has updated guidance on the information required for the manufacture and control of active substances used in medicinal products, with a 1 September 2026 date of application.
Read more
EMA: Q&A on the Implementation of 3DP Technology for Solid Oral Dosage Forms

EMA: Q&A on the Implementation of 3DP Technology for Solid Oral Dosage Forms

EMA added a new GMP/Q&A section on its website and published a dedicated Q&A document on 3D printing (3DP) for solid oral dosage forms.
Read more
What are the Prospects and Developments in the Operation of Computerised Systems?

What are the Prospects and Developments in the Operation of Computerised Systems?

Here's the answer:
Read more
Previous
Next