GMP Audit at a Contract Filler: Procedure and Checklist for Auditors
A GMP audit is the examination of a manufacturer for compliance with Good Manufacturing Practice. Pharmaceutical companies carry it out at every contract filler before entrusting sterile products to them, and repeat it at fixed intervals. The audit decides whether the site is added to the approved supplier list. This article shows how a GMP […]
Tech Transfer in Pharma: How a Product Moves to a Contract Filler
Tech transfer in pharma means the planned transfer of a manufacturing process from one site to another, for example from the pharmaceutical company to a contract filler. The goal is that the product is made at the new site with the same quality as at the old one. For sterile medicines, the transfer is the […]
Nearshoring in Pharmaceutical Production: Turkey as a Site on the EU Border
Nearshoring means relocating production to a nearby country instead of to distant low-wage countries. In pharmaceutical production this model is gaining importance because supply chains from Asia have broken several times in recent years. A site in the European part of Turkey combines short routes to Central Europe with spare capacity and competitive costs. This […]
Drug Shortages: How Spare Filling Capacity Helps
Drug shortages occur when demand for a medicine exceeds the available supply. One of the most frequent causes is not the active ingredient but the filling step. If capacity for sterile fill and finish is missing, the supply chain stops even though the API is available. This article explains the causes and shows how pharmaceutical […]
GMP Certificate: What It Proves and How to Verify It in EudraGMDP
A GMP certificate confirms that an authority has inspected a manufacturing site and established compliance with Good Manufacturing Practice. For pharmaceutical companies it is the first checkpoint when selecting a contract filler, because without a valid certificate a site may not produce for the EU market. This article explains what the certificate proves, what it […]
Process Validation in Filling: IQ, OQ and PQ Explained
Process validation is the documented evidence that a manufacturing process reproducibly delivers a product of the required quality. In sterile filling it is one of the obligations under EU GMP and a prerequisite for a batch to be released at all. Anyone who hands a product to a contract filler should know the procedure, because […]
Media Fill: How an Aseptic Filling Process Is Simulated
A media fill is the simulation of an aseptic filling process with nutrient medium instead of product. The filled units are incubated, and every turbid container indicates a contamination. In this way a sterile site demonstrates that equipment, personnel and procedures do not introduce microorganisms into the product. For pharmaceutical companies, the media fill is […]
Annex 1: What the Revision of the EU GMP Guide Means for Contract Filling
Annex 1 is the annex to the EU GMP guide that regulates the manufacture of sterile medicinal products. The revised version has applied since 25 August 2023 and has significantly tightened the requirements for cleanrooms, barrier systems, process simulation and documentation. For pharmaceutical companies that outsource sterile products to a contract filler, Annex 1 is […]
CDMO or CMO: Which Partner Pharmaceutical Companies Really Need
CDMO and CMO are two terms for service providers that manufacture medicines on behalf of others. A CMO, a contract manufacturing organization, takes over production according to a finished specification. A CDMO, a contract development and manufacturing organization, additionally supports the development of the product. Which form a pharmaceutical company needs depends on how far […]
Qualified Person and Batch Release: Who Releases Medicinal Products?
The Qualified Person, known in Germany as the Sachkundige Person, is the person who checks and releases every batch of a medicinal product before it is placed on the market. Without their certification, no medicine may be sold in the EU. Anyone who has products manufactured by a contract filler must therefore clarify who takes […]