Qualification of Your Pharmaceutical Plants
Qualification reporting. Master plans. Risk analysis. cGxP-compliant.
GMP compliant qualification of your pharmaceutical equipment and facilities
An important prerequisite for GMP compliance and efficient qualification and validation is an integrated concept right from the start of your project. This is the only way to save costs, resources and time and proactively implement regulatory requirements. We develop comprehensive qualification concepts in the early planning phase with the aim of minimizing project risks for you.
We know the requirements in the life science industry and provide you with comprehensive support in the qualification of your systems and processes. Whether according to your specifications or our proven standard, we carry out all qualification activities for your project according to a uniform system: from the development of qualification and validation master plans (QMP, VMP) to risk analyses (RA) and qualification plans and reports for all qualification stages (DQ, IQ, OQ, PQ). We check suppliers’ qualification documents according to your qualification specifications and carry out GMP audits.
For all quality assurance measures and GMP compliance activities, our professionally trained qualification team with extensive international expertise is at your side.
How much qualification/validation is necessary?
This question is in the centre of attention for each of our clients
and for us as well. The answer depends on several factors:
- Requirements of the regulatory authority (FDA, EU, etc.)
- GMP requirements for the relevant market
- Corporate validation strategy
- Experiences from other audits
Glatt expertise for your GMP compliance
With a proven track record of numerous projects for engineering and construction of pharmaceutical production facilities, Glatt Process & Engineering has gathered well-founded experiences in qualification tasks. We offer you full GMP compliance not matter whether lab or production equipment, media supply (WFI, AP, clean or pure steam), maintaining of cleanroom conditions by a ventilation system, qualification of rooms are involved.
Validation master plan and risk management
Given valid regulatory requirements the process of qualification must be logical, comprehensible and documented. An auditproof qualification and validation not only begins with the creation of a qualification plan but already long before. Therefore, start
with the establishment of a well-wrought qualification strategy, a validation master plan and with the identification of risks using risk assessment methods. For this, we are at your side with our comprehensive expertise from the pharmaceutical industry.
Double benefits
You will benefit twice from the creation of a vaildation master plan and an adequate determination of the qualification and validation expenses required. On one side you can keep the cost within reasonable limits. On the other side this helps to show the auditor your logical approach to qualification and the suitability of your equipment for production.
This procedure corresponds with our internal standard for the qualification of equipment within the scope of our projects and the order qualification. Based on these standards, we can support your project in every stage of qualification and validation.
What can you expect from us?
Glatt’s service portfolio in respect to qualification and validation
- Developing qualification and validation strategies
- Developing and producing master documents (validation master plan, qualification master plan, quality assurance and project plan)
- Developing and producing risk assessments based on established methods (FMEA, FTA, HACCP)
- Producing qualification plans (DQ/IQ/OQ/PQ)
- Undertaking qualification tests
- Producing qualification reports (DQ/IQ/OQ/PQ)
- Advising on how to implement process and cleaning validation
Further services from our portfolio
- Preperation, undertaking and documentation of factory acceptance procedures (FAT and SAT) on behalf of the client
- Compliance training of client’s personnel on GMP regulatory requirements
- Auditing of companies on behalf (supplier audits, supplier qualifications)
- Document management and updating according to customer’s requirements
- Customer-specific supplementary training offers for qualification, process and cleaning validation
Test us! Undertaking of qualification tasks based on your guidline documents or development of a projectspecific qualification and validation strategy – all that at reasonable costs.
Published article: ‘Qualification of pharmaceutical plants’
Practical aspects of reporting, master plan and risk analysis
For manufacturers of pharmaceutical products, the performance of equipment qualification is an elementary component of the quality management system and a prerequisite for obtaining and maintaining manufacturing authorization.
According to the definition of the EU GMP regulations, the manufacturer of pharmaceutical products proves with the qualification of his equipment that it is suitable for the intended purpose. (Article in German language)
- authors: Jens Lehmann, Wolfgang Röper, Glatt Ingenieurtechnik GmbH
- originally published in the magazine ‘CHEManager’, issue 3-4 2012, Wiley-VCH Verlag GmbH & Co. KGaA
Further information on this topic and related topics can also be found in the following publications:
Link to: Maintenance-free cleanroom washing area
January 2022: Glatt’s maintenance-free washing areas are perfect for cleanrooms
Link to: The design and modularisation of API synthesis plants
Copyright: HPCi Media Limited
Published article: ‘The design and modularisation of API synthesis plants’ PDF, English
Link to: With short time-to-market from process development directly to contract manufacturing
Copyright: Glatt
Published article: ‘With short time-to-market from process development directly to contract manufacturing’ PDF, English Reprint
Link to: Avoiding mistakes in cleanroom constructionCopyright: Vogel Communications Group
Published article: ‘Planning is everything. Avoiding mistakes in cleanroom construction’ PDF, Englisch
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