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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.