VALIDATION & VERIFICATION PROJECTS

What Is It ?

Validation and verification are critical quality assurance activities that demonstrate that a process, equipment, analytical method, or cleaning procedure produces consistent, reliable, and reproducible results in every operation.

Validation in the pharmaceutical, dietary supplement, and herbal product sectors is mandatory for :
- product safety,
- process consistency,
- mikrobiological control,
- supply chain reliability
- regulatory compliance 

This service provides scientific and technical documentation that your production processes are "properly designed", "under control", and "ready for audit."

Why Is It Necessary ?

- When processes or analysis methods are not validated, the product may exhibit batch-to-batch inconsistencies.
- When cleaning validation is not performed, there is a risk of cross-contamination.
- If variations in plant-based products due to extracts/drugs are not controlled, product safety is compromised.
- Validation deficiencies can lead to serious problems;
-- TITCK and other regulatory authority audit findings,
-- process stoppage,
-- product recall,
-- customer complaints,
-- export compliance rejection
- Validation is mandatory if there is a new production, product change, process optimization, or change in production location.
In short: A process that has not been validated is not technically or legally sustainable.

How We Do It ?

Validation Master Plan (VMP) Preparation
We define the framework for the entire validation approach:
- process validation,
- cleaning validation,
- equipment verification,
- software/digital system verification,
- laboratory analysis method
scope, risk assessment, and planning are carried out

Analytical Method Validation & Verification
For analysis methods used in drugs, dietary supplements, and herbal products:
- accuracy
- repeatability
- specificity
- linearity
- robustness
- detection/measurement limits
- validation studies are conducted according to these parameters.
Marker compound standardization in herbal products is also evaluated

Process Validation
- Determination of critical process steps
- Evaluation of production performance in different parameters
- Proof of inter-party consistency
- Control of extract variability in herbal products

Cleaning Validation
- Worst-case scenario selection
- Limit calculations
- Wash effectiveness verification 
- Control of cross contamination risk
Both chemical and microbiological cleaning requirements for dietary supplement facilities are evaluated

Risk Based Approach
All validation steps are planned using the ICH Q9 – Risk Management approach. In this way, time, cost and operational burden are reduced

Is It Necessary For You ?

If even one of the following questions is "Yes", validation service is critical for you:
1 - Are you not entirely sure whether your processes are delivering consistent results?
2 - Are you planning a new product, new production line, or production site change?
3 - Do you need scientific evidence that your analysis methods are valid?
4 - Can't you clearly prove the risk of cross-contamination after cleaning?
5 - Are you at risk due to validation deficiencies in customer audits, export, or contract manufacturing processes?

If there is even one "Yes" → The validation & verification process is a critical requirement for the safety of your product and audit success.