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Qualification And Validation

Qualification and Validation are integral part of Pharmaceutical and Healthcare projects. They are done to give a high level of assurance to the inspection authorities. In general they are defined as below,

Qualification – The documented verification that all aspects of facility, utility or equipment that can affect product quality.

IQ – adhere to approved specifications (e.g, Construction and Materials) and are correctly INSTALLED.
OQ – OPERATE as intended throughout all anticipated ranges.
PQ – PERFORMED as intended meeting acceptance criteria.

Validation (FDA)

Establishing documented evidence which proves a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

We have complete setup for plant qualification and validation as per FDA standards. Our Experience goes way beyond understanding of Qualification and Validation Procedures.

Qualification and Validation forms one of the most important aspect of Pharmaceutical Manufacturing industry. Our technical experts have hands on experience in successful documentation for the same as per International requirements.

The Qualification Scope :

Protocols and Testing

  • User Requirement Specification (URS) Drafting for the client
  • Design Review / Design Qualification (DR / DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Process Qualification (PQ)
  • Factory Acceptance Tests (FAT)

We can also take up enhanced Process Validation scope as per clients requirements.

Lotus carries out on-site Cleanroom Validation as stated by BS EN ISO14644 including:

  • As Built
  • At Rest
  • In Operation

Our engineers are fully trained in cleanroom practice and have an understanding of the requirements of BS EN ISO14644, PIC/s, WHO, ISPE and FDA.

We offer these services regularly in Pharmaceutical research and production facilities including hospitals, laboratories.

Cleanroom Validation Services Include The Following Tests:

  • Air Volume Flow Rates
  • Air Change Rate Calculations (ACPH)
  • Airborne Particulate Cleanliness Counts
  • HEPA Filter Integrity Leak Testing – DOP Method
  • Differential Pressure Measurements
  • Differential Pressure Gauge Calibration
  • Magnehelic Pressure Gauge calibration
  • Temperature, Humidity, Light and Noise Level readings
  • Recovery performance testing
  • Airflow visualization tests, supported by video and written report
  • Airflow balancing and plant remedial works

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