For this purpose, the manufacturing process has to be validated regarding all its critical steps by process validation (PV).

Valicare will support your PV activities by: 

1. The pre-requisites for successful Process Validation: 
- Calibration of all critical instruments on your process equipment
   including completion of relevant SOPs and calibration certificates 
- Equipment qualification demonstrating compliance of design,
   installation, function, and performance (DQ, IQ, OQ, and PQ) with
   the requirements of your process and product. 

2. Process Validation (PV): 
- Definition of the acceptance criteria using the parameters established
   in the registration dossier 
- Identification and description of the critical process parameters to be
   tested 
- Creation of “Challenge Tests” for demonstration of the processes
   capacity under “worst case” conditions and thus the overall
   reliability of the process
- Interpretation of all test results from manufacturing, IPC, and
   finished product
- Interpretation of all test results from utilities, clean rooms,
   representing the infrastructure of your process. 

Cleaning Validation (CV) 

Cleaning validation ensures the implementation of an efficient cleaning procedure which excludes “cross contamination” between different products or different batches of the same product. 

For documentation of GMP compliant cleaning validation on your manufacturing equipment Valicare offers support by verifying the pre-requisite qualification documents of cleaning in place (CIP) and utility systems. 

The validation protocols and reports prepared by Valicare contain the following: 

- Definition of the products and type of equipment to be tested which
   in case of greater number, will be determined by “matrixing” for
   equipment and “bracketing” for products which ones and in which
   combination will be included in the validation testing
- Definition of the “guide substances” out of the products as well as  
   the cleaning agents and their acceptance criteria
- Definition of the sample method 
- Definition of the analytical methods 
- Results and deviations are documented as well as the follow up
  activities 
- Suggestions for process optimisation 

Method Validation (MV) 

According to international GMP guidelines analytical methods used in chemical and microbiological Quality Control Laboratories have to be validated prior to implementation in routine analysis. 

This means that for chemical analysis non-compendial methods need to be validated. The evidence has to be documented that the method is reliable and delivers – under given conditions – correct test results. 

For this purpose the following requirements have to be met.: 

- Qualified analytical equipment 
- Proof of equipment suitability for the given method (“system
  suitability”) 
- Recorded quality parameters like:

• accuracy 
• precision 
• specificity
• limit of detection 
• linearity
• range
• robustness

Valicare specialists in chemical analysis support you by establishing a GMP concept as basis for the validation of your analytical methods. This comprises preparation of the validation protocols and advice for treatment of deviations. 

For microbiological analysis methods like: 

- Detection of viable micro organisms via sterility testing 
- Enumeration of total viable micro organisms 
- Detection of specific microorganisms 
- Identification using automated systems 

Valicare offers competent support by our microbiologists in preparing GMP compliant validation protocols on the basis of the requirements of your inspecting authorities. This includes the choice of typical microorganisms isolated in your manufacturing environment for method validation.