DOCUMENTATION & VALIDATION SERVICES

Validation

There are two types of validation
a. Process Validation
b. Product validation
We have expertise to do validation in the following process as per WHO guidelines
1. Validation of the HVAC system: Our validation includes
a. Pressure Differential
b. ACPH : Air Change rate per hour
c. Particle Count
d. HEPA integrity testing
e. Air flow pattern
f. Temperature mapping
We do the complete documentation as per latest WHO guidelines.
2. We expertise in Validation of complete water system i.e. Phase 1 , Phase 2 and Phase 3. Both Purified Water and Water for Injection system needs validation
All the analysis of the samples can be done in-house with in-house staff. We can also undertake to do the testing part, provided the client provides us with necessary instruments

Documentation

We have one of the best documentation team to crater to all your documentation needs
We provide documentation according to your needs and the need of the statutory body.
A complete one point solution for Registration of Pharma , Cosmetics and Medical Devices.
Complete documentation from Site Master File , Quality Manual to SOP's and APQR.
Contact us for all your needs at
engg@cleantechsolution.in