Validation Studies

CAL

The validation department at CAL has been an efficient and strategic partner with many companies in validating test methodology, manufacturing processes and cleaning protocols.


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CAL is able to assist your firm in designing and executing Validation Protocols.

Validation refers to establishing documented evidence that a process or system performs reproducibly in order that the resulting finished product confirms written product specifications.

Regulated products often require Validation Studies to support manufacturing, production and analytical processes. At the core of these studies is a requirement for repeated analytical determination of the analyte under diverse conditions.
Method Validations are preformed to meet current ICH (International Conference on Harmonisation) guidelines. We can develop, write and execute the protocol for Method Validations.

Various government agencies, pharmacopeias and international bodies have published requirements for validation studies.

CAL’s highly experienced scientists are equipped with an array of the latest instrumentation and analytical techniques including: HPLC, GC, FT-IR, UV and ICP to develop and optimize methods. We work closely with our clients to develop and validate specific, sensitive and accurate methods.


Validation parameters include:

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  • Method Precision
  • System Precision
  • System Suitability
  • Limit of Detection (LOD)
  • Limit of Quantitation (LOQ)
  • Recovery Studies
  • Linearity
  • Specificity
  • Forced Degradation
  • Robustness

When a Customer supplies the Validated Method
  • 1. We follow the Method provided
  • 2. We do a Method Transfer
  • 3. We do a mini Validation
  • a) Precision
  • b) Linearity
  • c) Ruggedness
  • 4. When Method is validated it is transferable from one lab to another
  • 5. Strictly confidential held under lock and key
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The Validation Services available from CAL are as follows:

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  • Writing and updating the Master Validation Plan
  • Analytical test method validation

The Validation department has staff that is qualified and trained to design and execute Validation strategies.