行业专家撰文介绍泡罩包装线确认的七项降本建议
Save Time and Money when Qualifying a Blister Packaging Line
Pester Pac Automation 的 Rainer Röcker 在 GMP-Verlag LOGFILE 19/2026 撰文，给出泡罩包装线确认中节省时间与成本的七项建议，文章摘自 GMP Compliance Adviser 第 13.C 章。
Save Time and Money when Qualifying a Blister Packaging Line
21.09.2026
-
LOGFILE Feature
Excerpt from the GMP Compliance Adviser, Chapter 13.C, Qualification of a servo-controlled blister packaging line
4 min. reading time | by Rainer Röcker, Senior Sales Manager Pharma Germany S&E, A, CH, Italy, Pharma Liquid at Pester Pac Automation GmbH
Published in LOGFILE 19/2026
Qualifying a blister packaging line is not only technically demanding, but also time-consuming and costly. Here you will find important tips on how to organise your qualification process in a cost-effective yet gmp-compliant manner.
The qualification of a blister packaging line typically follows the well-known “V-Model” described in GAMP® 5 (see figure 1). The V-model consists of the design phase, in which the requirements are defined (left-hand branch), and the specification phase, in which the requirements are verified (right-hand branch). The ‘tip’ of the V-model corresponds to the construction, delivery and installation of the plant and the associated acceptance tests. And this is precisely where the potential lies for a cost-effective yet GMP-compliant qualification process. Let's take a closer look at that today!
Abbildung 1 | Course of project based on the V-model
How to Integrate FAT and SAT Successfully?
Once the plant has been built in accordance with the specifications drawn up during the design phase, a comprehensive Factory Acceptance Test (FAT) is carried out, using test protocols previously approved by the equipment operator. The FAT is a quality inspection of the equipment that takes place at the manufacturer’s premises prior to delivery (factory acceptance). During this process, the equipment is checked for completeness, functionality and conformity with the order, to avoid delays caused by faults and rectifications at the customer’s site. The FAT is carried out by the manufacturer, often in the presence of the customer.
Following a successful FAT and installation of the system at the operator’s site, it is advisable to carry out a comprehensive Site Acceptance Test (SAT). The SAT is the technical acceptance test following delivery and installation. During the SAT, the correct installation, all performance characteristics, properties and functions are checked against the system specification and the approved technical design. The equipment is only commissioned once the SAT has been successfully completed.
FAT and SAT are elements of Good Engineering Practice and, in addition to technical tests, also serve to verify contractual agreements. They are not elements of GMP qualification. Nevertheless, many of the tests and checks carried out as part of FAT and SAT are activities that are also required as part of a qualification process, in particular Installation Qualification (IQ) and Operational Qualification (OQ). Whereas tests were often carried out multiple times in the past, synergies can now be exploited by coordinating tests and acceptance criteria in advance and defining the requirements for GMP-compliant documentation. This approach is referred to as Commissioning & Qualification.
It is often advisable to formally approve FAT and SAT documents and to use parts of them for qualification or to refer to them. However, a prerequisite for using FAT/SAT documents for qualifications is that they meet the requirements for GMP-compliant documentation. To this end, the FAT/SAT procedures are described in greater detail, particularly the process steps involved in the tests and how they lead to reproducible results.
The FAT protocols are reviewed and approved by the client’s quality assurance department prior to the FAT being carried out at the supplier’s premises. Any changes may also affect the qualification documents. Those FAT tests that are also relevant to the subsequent installation qualification (IQ) do not need to be repeated during the GMP qualification, provided that dismantling, transport and reassembly at the destination do not affect the conduct of the test or the result previously achieved. The same applies to the synergies between SAT and operational qualification (OQ). This approach saves time and money. Above all, the equipment can go into production sooner.
It is important to incorporate the relevant tests into the risk assessment. The ‘risk-based approach’, combined with active supplier involvement, thus leads to a more cost-effective qualification process.
Seven Tips for Efficient Qualification
It is possible to carry out a cost-effective qualification of blister packaging systems that complies with regulatory requirements by taking the following aspects into account:
1 | Perform supplier evaluation prior to awarding the project |
2 | Combine the requirements specification and functional specification into a single document |
3 | Include all variable data in the configuration specification |
4 | Keep the configuration specification in draft form for an extended period |
5 | Perform risk assessment focusing on GMP-relevant functions and make cross-reference to the IQ and OQ tests to be carried out |
6 | Commissioning & Qualification: capitalise on synergies by referring to tests already carried out by the manufacturer |
7 | Integrate the equipment manufacturer’s qualification documentation into your system |
Do you have any questions or suggestions? Please contact us at: [email protected]
You may also be interested in the following articles:
02.10.2026
FDA: Adjustment of Nitrosamine Limits for Short-Term Use Medicines
The FDA has updated its recommendations on Acceptable Intake (AI) limits for nitrosamine impurities. Under certain conditions, the Agency now accepts a Less-Than-Lifetime (LTL) adjustment of AI limits for medicinal products that are not intended for lifetime use. This also represents an alignment with the LTL concept of ICH M7(R2).
02.10.2026
Swissmedic: SMS Registration Becomes Prerequisite for GMP Certificates
As of 15 November 2026, active substances must be registered in the EMA's Substance Management Services (SMS) database before Swissmedic can include them in establishment licences and GMP certificates for active substance manufacturers. The new requirement results from modifications to the EudraGMDP database.
02.10.2026
EMA: New Q&As for Biological Medicinal Products
The EMA has added a new section to its Q&As on biological medicinal products addressing medicinal products containing secretomes or extracellular vesicles (EVs) obtained from human or animal cells.
02.10.2026
EU: Council Adopts the Pharmaceutical Package
On 28 September 2026, the Council of the European Union adopted the EU pharmaceutical package, marking another important step in the legislative process for the comprehensive reform of EU pharmaceutical legislation.
25.09.2026
EMA: Report on First Bilateral Meeting with APIC Published
The EMA has published the highlights of its first bilateral meeting with the Active Pharmaceutical Ingredients Committee (APIC). Topics included GMP oversight of API manufacturers, the reuse of recovered solvents and nitrosamine risks.
21.09.2026
Save Time and Money when Qualifying a Blister Packaging Line
Qualifying a blister packaging line is not only technically demanding, but also time-consuming and costly. Here you will find important tips on how to organise your qualification process in a cost-effective yet gmp-compliant manner.
Related Products
GMP Compliance Adviser | Named User Licence | 12M
With an named user licence, one user can access the knowledge portal; with a corporate licence, any number of users can access it.Approx. 5,000 pages of practical GMP knowledge with illustrations and forms: Practical guidance for rapid implementation in the workplaceDetailed descriptions of GMP-compliant systemsInternational laws and guidelines Always up-to-date thanks to regular updates Download Advantages and Prices60+ Sample Documents In addition, the GMP Compliance Adviser contains more than 60 sample documents (MS Office) and practical examples that you can use.Sample SOPsSample FormsSample ReportsSample DocumentationChecklistsProcess Diagrams (Flowcharts)Practical Examples of QRM Application (e.g., Risk Analyses)Sample Documents for Qualification and ValidationCase StudiesWritten by more than 80 authors with hands-on experience directly linked to the industryA team of over 80 experts interpret regulatory requirements and describe how they are implemented in practice.The authors are experienced in the pharmaceutical industry, consulting, and government agencies.
delivery immediately after receipt of payment
€1,368.00 net excl. VAT
GMP:KnowHow Pharma Logistics (GDP) | Named User Licence | 12M
Your knowledge portal for GDP-compliant pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, comply with regulatory requirements. The GMP:KnowHow knowledge portal guides you through the complex regulatory landscape of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Interactive graphics help you navigate all areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves valuable research time.One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? GMP:KnowHow Pharma Logistics (GDP) is a practical knowledge portal dedicated to Good Distribution Practice (GDP). It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante, currently Director Quality at Fisher Clinical Services, previously served as Head of Quality Control and Responsible Person (GDP) for the Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.
delivery immediately after receipt of payment
€610.00 net excl. VAT
E-Learning GMP:READY | Specialist Knowledge GMP for Engineers
Why are GMP rules important for technicians and engineers? Technicians and engineers play a key role in ensuring compliance with Good Manufacturing Practice (GMP) standards. They are involved in critical activities such as: planning and construction of ventilation systems, maintenance of water treatment plants, calibration of measuring sensors. Therefore, they are jointly responsible for the quality of medicines and must ensure that their work complies with GMP standards.Your advantages: Fast familiarization with GMP topics in approx. 2 hours, time- and location-independent online training, printable personal certificate, 12-month access for initial and follow-up training, automatic updates in case of legal changes,content compliant with Article 7(4) of Directive 2003/94/EC.The Author This e-learning course was developed with the collaboration of Dipl.-Ing. Andreas Nuhn (D & B Pharmadesign GmbH).
delivery time appr. 2-5 workdays after receipt of payment
€245.00 net excl. VAT
GMP Fundamentals | A Step-by-Step Guide
This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previously acquired knowledge. Some topics are: GMP: Purpose and basic pharmaceutical terms Laws, licenses and inspections Personnel: Responsibility and hygiene Standard Operating Procedures (SOP) and documentation Design of rooms and facilities Processing and packaging Quality control and market release Suppliers, storage and logistics (Good Distribution Practice = GDP) Alphabetical index and abbreviations Using practical examples and comparisons to every-day life will help to easy understand GMP regulations.GMP Fundamentals is a helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.
delivery immediately after receipt of payment
€44.90 net excl. VAT
来源：GMP-Verlag LOGFILE Feature · gmp-publishing.com