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Special services for
pharmaceutical companies
and related industries
 



 
PHARMACEUTICAL PROJECTS


Take advantage of our experience in the following areas:


Engineering and economics

Facility design and layout utilising 3D CAD
Tendering and acquisition of facilities
Assessment of demands
Computer validation
Compilation of requirement specifications
Preparation of presentations
Development of extension strategies
Modernisation and reconstruction
Optimisation of manufacturing pocesses
Product development
Product transfer
Project management
Qualification of facilities
Validation of manufacturing processes
Validation of cleaning processes
Calculation of profitability
21CFR11-compliance implementation

Reorganisation

Analysis and strategy development
Due delegence testing
Calculation of profitability

Quality assurance

GMP-analysis und GMP-consultation Solid base for optimization of your QA-System is given by a thorough analysis of your GMP status and a consultation which offers you individual answers to eventually existing gaps.
We offer you guidance and support for planning improvements and implementation of measures.
GDP-analysis und GDP-consultation End of 2013 the new Good Distribution Practice Guideline has led to a series of changes.
Are you already prepared?
We will be happy to provide consulting on this topic. We also perform GDP-Audits on your behalf.
Set up, adaption and updating of
quality systems
Based on an analysis of requirements PharmaSupport takes over the design of your Quality-System.
For you we create the necessary system documents, like SMF, quality manual, SOPs etc.
Creation of QA-documents Many documents are necessary to ensure compliance. We support you to create qualification and validation documents, PQRs (Product Quality Reviews), etc.
GMP in-house training / external
guest speakers at seminars
Due to our expertise, we are able to offer you practical GMP-training. We offer general courses as well as in-depth training on special topics in the GMP-/GVP-/GDP- area.
Preparation of inspections Take advantage of our comprehensive experience in the area of inspections to prepare you for the visit of your authority.
Depending on your demands we make an individual analysis of your Quality Assurance System, offer mock-audits and help you filling existing gaps. Your employees will be prepared by training to act properly during audits and inspections.
Worldwide Audits of suppliers Take advantage of our long lasting experience in performing audits at pharmaceutical companies, raw material manufacturers and equipment constructors.
Tracing and tracking of Changes,
CAPAs etc.
Sometimes the tracking of measures fails due to lacks of capacity. We support you and offer consistent follow up even of complex topics.
Creation of Quality Assurance
agreements
The existence of a contract concerning every manufacturing process which is performed by third parties is obligatory. Profit from our knowhow concerning GMP-contracts. We help you to create Quality Agreements fulfilling the GMP requirements but also include all your individual demands.

Regulatory affairs


Compilation of documents according to CTD-format
Support in preparing the IMPD documentation (chem.-pharm.part)


 
 
 
   
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