According to recent information, the global batch release testing market was valued at approximately USD 1.5 billion in 2023 and is projected to reach around USD 3.2 billion by 2032. That represents a compound annual growth rate (CAGR) of 8.5% during the forecast period [1] – and it is significant.
Despite unified EU regulations, individual member states may apply their own specific requirements, complicating the path to market access for companies from third countries. Choosing to conduct your batch release testing in the labs of Conscio Group offers a strategic advantage.
With its laboratories in Czechia, Slovakia, and Austria – located in the “heart of Europe” – Conscio provides direct access to all 28 EU member states. This central location ensures efficient logistics, reduced turnaround time, and improved cost-effectiveness. Our deep knowledge of regional and EU-level requirements helps streamline the compliance process, reducing regulatory hurdles and time-to-market.
This white paper outlines the essentials of the batch release testing procedure and demonstrates the added value of working with Conscio Group – a trusted European partner with comprehensive analytical capabilities.
“We have been working with Conscio Group for nearly 10 years now, and their batch release testing services have been consistently providing us with the assurances and efficiencies. This has been one of the very key supporting factors to achieve the successes of our commercial operations. Their team has demonstrated professionalisms, great collaborations, and flexible adaptations to our evolving needs over the years. We are very satisfied with their services and look forward to continuing our partnership in long run.” – Jack Jing, General Manager, Seacross Pharmaceuticals
What You Need to Know About EU Batch Release Compliance
The quality of pharmaceutical products imported into the EU from countries without Mutual Recognition Agreements (MRA) is controlled by strict quality standards. These requirements are established in Annexes 16 and 21 of the EU Good Manufacturing Practice (GMP) guidelines, which offer precise guidance on the complex activity of importing medicinal products into the EU.
According to EU regulations, all medicinal products (human and veterinary) imported into the European Economic Area (EEA) from third countries must be re-tested for compliance with the EU marketing authorization (MA) and certified by a Qualified Person (QP). Only then can these products be released onto the EU market.
Moreover, there are basically 3 main regulatory documents that define the basic rules for pharmaceutical manufacturers in respect to batch release activities:
- Directive 2001/83/EC: Establishes the Community code for medicinal products for human use, harmonizing national rules and supporting the EU internal market.
- EU GMP Annex 16: Defines the roles and responsibilities of the Qualified Person in certifying that each batch complies with the MA and GMP.
- EU GMP Annex 21: Covers importation requirements for medicinal products and defines obligations for Manufacturing Import Authorisation (MIA) holders, including for investigational, veterinary, and human-use medicines.
These documents ensure that imported products are of the same quality, safety, and efficacy as those produced within the EU.
The Importance of Batch Release in the Pharma Industry
The main aspects of the batch release (BR) process within the EU are to ensure the quality, safety, and efficacy of medicinal products for patients. Before any product is marketed in the EU, it must pass through a rigorous review process that includes:
- Detailed examination of batch records.
- Quality control testing.
- Confirmation of GMP compliance.
The QP is ultimately responsible for ensuring that all aspects of production and testing meet the applicable standards. Every QP must be authorized by the regulatory authority within the respective EU member state. The QP’s responsibility is to certify that each batch of medicinal products complies with quality standards before they reach the market. The quality of the analytical data plays a crucial role in the QP’s final decision on whether the medicine complies with the required drug specifications.
MRA and Non-MRA Countries – What’s the Difference?
As mentioned earlier, medicines imported to EEA from countries without MRAs must undergo batch retesting within the EU. MRAs exist with countries such as Australia, New Zealand, USA, Canada, Switzerland, Japan, and Israel. These agreements allow for mutual acceptance of certain processes, such as manufacturing and QC testing, meaning batch retesting may be waived.
However, manufacturers from MRA countries must provide documented evidence that GMP was followed throughout production, shipment, and storage. Without such evidence, exemption from retesting may not be granted.
On the other hand, manufacturers from third countries without an MRA must retest every batch imported into the EU. This must be performed by an EU-based laboratory with valid GMP certification, and all activities must adhere to current GMP (cGMP) standards.
“Conscio made it possible to streamline very time-consuming stages of process setup, free up internal resources, and boost production at a critical time.” – Novavax (CZ Site)
QC Batch Release Testing
The core of the batch release process is the verification of qualitative and quantitative product attributes (collectively known as QC testing).
This is done through:
- Physical testing (e.g., appearance, disintegration, hardness, friability)
- Chemical testing (e.g., assay of active ingredients, degradation products)
- Microbiological testing (e.g., TAMC, TYMC, sterility, endotoxins, specific pathogens)
Due to the diversity of dosage forms and therapeutic areas, a QC laboratory must be equipped with a wide array of validated analytical techniques. Conscio Group laboratories in Czechia, Slovakia, and Austria are specialized in batch release testing and possess decades of experience.
All testing must be conducted under cGMP conditions. Analytical methods must be suitable for their intended use, supported by proper validation, verification, or analytical method transfer (AMT). When methods are transferred from a manufacturer, prior validation is assumed, and the receiving lab must ensure successful implementation.
Microbial testing is an equally vital component and must be conducted in parallel with chemical analysis to ensure product safety. Typical microbiological tests include Total Aerobic Microbial Count, Total Yeast and Mold Count, and detection of specific pathogens such as Escherichia coli or Salmonella spp.. For sterile products, additional tests like sterility and bacterial endotoxin testing are required. In the case of biological drugs, further specialized tests may include the detection of mycoplasma or spiroplasma.
All procedures are overseen by the Quality Assurance department and QPs to maintain full regulatory compliance.
Methods Implementation – Ready or Not?
In many cases, even though methods are verified in the transferring lab (i.e., the lab that has implemented the methods) and the client declares that the methods are flawless, there is no guarantee that the methods will work without issues in the receiving lab (i.e., the lab that is supposed to implement the methods for routine batch release testing). In practice, many methods require adjustments to work under the specific conditions of the new environment.
To mitigate risk, Conscio’s receiving labs perform method checks before cGMP testing begins. This reduces the likelihood of Out Of Specification (OOS) results, which could delay projects and trigger costly investigations.
Our analytical R&D teams support method: verification – optimization – troubleshooting.
If a contract lab lacks in-house R&D capabilities, method implementation can become a critical bottleneck. Time is often of the essence for such projects, and delays during the implementation phase can be very painful from both cost and time perspectives.
“It can be trusted that everything works fine. Generally, very flexible and when something is really needed, Conscio has been able to do it. There is always transparency in the cost structure.”
– A Scandinavian pharmaceutical manufacturer
Why Choosing the Right Partner Matters – And Why Conscio Group Delivers
As this paper has shown, batch release testing is far more than a regulatory formality — it’s a critical control point that safeguards the quality, safety, and marketability of pharmaceutical products within the European Union. Choosing the right analytical partner is not merely a technical decision; it is a strategic investment that can determine the efficiency, compliance, and ultimate success of your product’s market entry.
From method implementation to regulatory oversight, batch release requires flawless execution across multiple disciplines — analytical chemistry, microbiology, quality assurance, and GMP compliance. Any delay or deviation can compromise your timelines, trigger costly investigations, or worse, lead to rejected batches.
That’s why partnering with an experienced, flexible, and fully GMP-compliant laboratory is not just advantageous — it’s essential.
At Conscio Group, we offer a complete solution for batch release testing, supported by more than 300 pharmaceutical professionals across our strategically located laboratories in Czechia, Slovakia, and Austria.
With over 20 years of continuous operation under EU and US-FDA regulatory oversight, we have the infrastructure and expertise to handle a wide variety of dosage forms, manufacturing scenarios, and regulatory challenges.
Our integrated services include:
- Evaluation and physical check of analytical methods
- Full method implementation: AMT, method verification, and validation
- Analytical method development and optimization (as needed)
- QC testing of clinical and commercial medicinal products
- Chemical, physical, and microbiological examination under cGMP
- Testing of raw materials, excipients, and APIs (per pharmacopeial or client specifications)
- QP data review and certification for EU market release
- Batch release in accordance with your Marketing Authorisation
- 250 m³ of stability chambers for both ICH and atypical storage conditions
In addition, our services cover analysis of:
- A wide portfolio of dosage forms: solids, semi-solids, liquids, injectables, ODFs, patches, and more
- Highly potent compounds (up to OEB5), controlled substances, sterile products, and biologics such as monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and oligonucleotides
Whether you are launching a new product, expanding into the EU market, or seeking to streamline existing processes, Conscio Group is ready to be your trusted partner.
We don’t just perform tests — we deliver regulatory assurance, operational flexibility, and peace of mind.
info@consciogroup.com
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