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Quality needs to be designed into a product - it cannot be tested into it.


Validation Masterplan

The validation master plan is key for each quality system and an important part of the company. 

Do you need support? Are you not satisfied with the concept of your validation master plan?

We develop or re-assess your validation masterplan (VMP) by taking into consideration the following topics:

  • Process validation
  • Equipment qualification and calibration
  • Analytical instrument qualification
  • Method validation
  • Cleaning validation
  • Computer software validation (CSV)

Process Validation for Synthesis / Formulation / Filling and Packaging

Do you correlate validation with generation of vast numbers of papers and perceive it as generally just tedious? Do you have resource bottleneck? Do you know the new guideline Annex 15?
We support you with validation activities according to Annex 15 by employing new or old procedures (process qualification) or even developing a hybrid variation.
We help you to carry out the validation professionally by combining our know-how and production experience with quality management. We also support you in setting up the risk analysis as well as challenging it; we evaluate the critical process parameters (CPP) and, in parallel, define IPC controls and SOPs.

Based on those data, we generate the validation protocol, provide on-demand support during validation activities and/or generate the validation report. 

We can support you during the entire validation process or on selected parts.

Process Qualification

The process qualification includes four steps:

Step 1:     Process Design - Definition of the process.
Step 2:     Performance Qualification - The equipment as well as the infrastructure is determined.
Step 3:     Process Performance Qualification - The process is shown to be reproducible.
Step 4:     Continued Process Verification (CPV) - The continuous verification, whether the process is still under control.

Do you have your own process planning and development under control? 
Do you know the risks? Do you know your process?
In order to qualify your process correctly, you should be able to answer those questions. Due to our long lasting experience we can support you on all those steps.

Validation of Analytical Methods

You have to develop suitable analytical methods for the release of new products. These methods need to be validated in the GMP environment prior to the start of clinical trials. 
You have to show evidence, that the analytical method is suitable for its intended use. 

We support you in the generation of the validation protocol as well as the validation report. 

Do you need to know whether a full validation is needed or a verification of the methods is sufficient?  We assist you with these decisions.

Validation of Cleaning Processes

During process development, the development of the corresponding cleaning process and its validation is often treated with low priority. With the use of multipurpose equipment, cleaning validation is key and its concept needs to be reviewed in detail. 

How did you develop your cleaning procedures? Is "visually clean" enough or do you have other criteria? What is important for you?
Do you know your worst case? Did you calculate all the risks? On what did you base your calculation?
Are your processes validated? Which cleaning procedures are in use? Do you know the MACO (maximum carry over) of your detergents?

In case you do not have an answer to all those questions, we are happy to assist you.


Qualification of process equipment

Did you purchase a new equipment? Do you plan serialisation (Track and Trace) and do you need to qualify your equipment and want to know how? Do you want to perform qualification according to FDA, EMA or GxP?

We support you in establishment of the

  • Qualification plan
  • Risk analysis
  • URS (User Requirement Specification)
  • Functional specification
  • Design qualification (DQ)
  • FAT (Factory Acceptance Test)
  • SAT (Site Acceptance Test)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Process qualification (PQ)
  • Final report

Qualification of analytical equipment

Do you plan to purchase a new equipment for your GLP/GMP laboratory? Do you require assistance or do you experience a bottleneck in ressources for the generation of the corresponding documents?

We support you and generate and/or review all needed documentation or parts of it.

Quality by Design (QbD)

Is QbD unknown to you?

As a requirement of the new guidelines, process know how and quality awareness should be combined. The following principle is valid: quality cannot be tested into a product. The focus has therefore shifted from quality control to process understanding. The combination of ICH Q8 (pharmaceutical development), ICH Q9 (quality risk assessment) and the ICH Q10 (pharmaceutical quality system) is the key to success.

Do you know your quality relevant factors of your process? Which factors can be covered by QbD? Which factors can be influenced? Do you have answers to all those questions? We support you with our 20 years of experience.

We assist you during the development phase of your product, precisely in

  • Definition of your quality target product profile (QTPP)
  • Definition of your production process
  • Definition of your critical quality attributes (CQA)
  • Definition of your first critical material attribute (CMA) and the relevant critical process parameters (CPP)

In doing so, we generate your first risk assessment as well as the master batch records (MBR) with the corresponding documents.

During process development we support you with:

  • Review and adaption of the CQA
  • Functional dependance of the CMA, CPP and CQA as well as the corresponding measures
  • IPC Strategy (InProcess Control)
  • Process risk analysis (FMEA Failure Mode and Effect Analysis)


Does the PQR/APR (Product Quality Review/Annual Product Review) represent for you only an accumulation of data, that is tedious to compile?
Correctly designed and evaluated, the PQR can be a wonderful tool. You can use your PQR for your in-house continuous improvement activities as well as for the ongoing surveillance of your processes.

Furthermore, trend analyses as required by the FDA, can easily be established with the PQR.

We help you to put together the PQR and evaluate your data.

Software Validation

Here we work together with a partner. Together we can offer the full range of the SW Validation (Software Validation). We can support you with the following tasks:

-      Preparation of the user requirement specification (URS)

-      Based on your needs the corresponding validation protocol

-      Support you with your risk analysis

-      We also can support you active with a wide variety of validation tasks (collaboration in validation projects, planning and moderation of workshops, prepare the test protocols as well as support you during the test, prepare and document go live simulation as well as the actual go live). 

-      Audits (System audits and analysis of critical points, audits at vendors and service providers). 

-      Expansion of quality system (write "Standard Operating Procedures" for computer validation and system operations).

It is important to understand who is responsible for what (software provider vs. customer) and define the corresponding responsibilities from the start. Additionally, it is crucial to understand when the guidelines start to be valid (eg change control).

If you do not feel confident we can support you together with our partner.