Validation is a methodical approach, where data is analyzed as well as collected to settle that a procedure will operate within the stated parameters, whenever essential. Also, it ensures that the process will produce reliable results within the prearranged specifications. The process confirms, if the compliance as well as quality principles are being seen by a product in real time. In short, Validation is well-defined as a renowned program that renders a high degree of assurance that a specific procedure, technique, gadget or system will steadily yield a result that runs into pre-determined acceptance standards.
In a pharmaceutical flair, the validation program insures that a company is running into the Current Good Manufacturing Process (cGMP) guidelines that have been set for the business by concerned regulatory figures.
Validation is concerned primarily with procedures. When the identical method is applied to a mechanism or any apparatus instead of a procedure, it is mentioned to as Qualification instead. Qualification is not restricted to a Validation course, but it is a share of it. It can be further sectioned into Performance Qualification (PQ), Installation Qualification (IQ), or Operation Qualification (OQ).
Our company renders a wide variability of Validation Services, which meet ICH, FDA and numerous European standards. We are well prepared with essential Validation Accessories as well as SOP to carry out On-site Validation Procedure for following list of Devices in all Pharmaceutical Industries.
1) Horizontal Steam Sterilizer (Horizontal Autoclave)
2) Vertical Steam Sterilizer (Vertical Autoclave)
3) Hot air oven Dry Heat Sterilizer
4) Cooling chamber
5) Cold Room Stability Chamber
6) Walk-In Stability chamber
7) Refrigerator Freezer
8) SIP System
9) CIP System
10) Water bath Heating block
Why EIEs Validation Services?
1) Team of Qualified and Well Trained Engineers
2) 3 decades of manufacturing experience in accordance to GMP Guidelines
3) Separate QA as well as Documentation Section to achieve complex activities on priority basis
4) All Reporting jobs conforms to National & International as well as Major Regulatory bodies such as MCC, TGA, WHO, USFDA, FDA, MHRA, ISO etc
5) Quick Services as well as Rapid Reporting
6) On-Site Calibration as well as Validation Competence
7) Remind Clienteles for due date of Equipment Validation activity & Instrument Calibration by Mail/Telephonic.
8) Calibration amenities are given the highest significances at our organization. We hold outstanding technical know-how to standardize multipurpose calibration parameters with National as well as International Traceability.
9) The in-house Calibration Lab is credited by NABL Authorities according to IEC/ISO : 17025 Strategies.
The Laboratory is well equipped with the most up-to-date as well as sophisticated Equipment & Reference / Master Instruments Standards, which are active for rendering precise & correct calibration services to the respected clients. We deliver 2 kinds of calibration facilities to our esteemed clients. The varieties of solutions are bulletined below:
1) In house calibration service
2) On-Site calibration Service