Intertek ASG Laboratory, Manchester, UK

Analytical Method Remediation

Analytical Method Validation

Pharmaceuticals and Biopharmaceuticals

Pharmaceutical analysis is highly regulated and analytical methods used to assess the quality of pharmaceutical products must be validated in accordance with current regulatory guidelines. Additionally, ICH guidelines are also in place to ensure that as products and processes evolve, analytical methods are continuously assessed throughout their life-cycle.

For established pharmaceutical products the analytical methodology that supports the production and release should undergo review throughout the product’s life cycle, in terms of the validation status, efficacy and efficiency. Intertek ASG can provide the services necessary to support this process to maintain regulatory compliance and improve performance.

Working within the ICH guidelines Q2 (R1) our specialist pharmaceutical analysts in conjunction with Intertek ASG’s highly experienced QA department can provide the following services:

• Evaluation
  A critique of the analytical method to identify gaps in the existing validation and proposal of a remediation plan.

• Assessment
  An experimental investigation to ascertain the likely success of validation against suitable acceptance criteria.

• Optimization
  If necessary the method(s) will undergo modifications to ensure a successful validation.

• Method Validation
  Validation of the analytical method against agreed validation protocols, and in accordance with appropriate regulatory standards. A validation report with QA review along with a published method detailing all operating parameters and system suitability tests will be provided.

• Method Transfer
  If required the methods can be transferred either back to the client laboratory or on to other contract analytical laboratories either as part of the method validation process or a separate protocol.

In partnership with Intertek ASG, regulatory compliance can be achieved and, at the same time, the performance of analytical methods can be improved leading to fewer lab investigations and greater efficiency of operations.

See Also:

• Analytical Method Development

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