Validation of analytical methods in GMP clean laboratories

Validation of analytical methods in GMP clean laboratories

Method validation is a document that proves that the target analytical method meets the expected requirements. It is not a one-time event and should follow a life cycle approach. Method validation begins with method development in a GMP clean laboratory and ends with method decommissioning. It should be ensured that the method is in the life cycle Compliant in...

Text label: GMP clean laboratory, pharma machinery analysis method verification

Validation of Analytical Methods in GMP Clean Laboratories

Method validation is a document that proves that the target analytical method meets the expected requirements. It is not a one-time event and should follow a life cycle approach. Method validation begins with method development in a GMP clean laboratory and ends with method decommissioning. It should be ensured that the method is in the life cycle meet the specified standards.

1.GMP requirements for analytical method validation and validation

Analysis method is a test method set and established to complete the inspection project. It describes in detail each step of completing the analysis and inspection, generally including the principle of analysis method, instrument and instrument parameters, reagents, test solution and control Preparation, determination, calculation formula and limit requirements of product solutions, etc.

Method validation is a formal, documented certification document that verifies the ability of a test procedure to be used for an intended purpose. Method validation should be performed with reference to a written, approved protocol or plan that specifies the acceptance criteria for validation.

The definition of the life cycle of analytical methods in the draft of General Chapter 1220 Analytical Method Life Cycle published by USP-PF is divided into the following three stages.

(1) The first stage method design stage

Based on QTPP and product CQA and process control requirements, determine the analytical target profile (ATP) and method key performance characteristics, and carry out activities in method development and understanding. First, select appropriate analytical techniques and method conditions that can meet ATP requirements for method development. Generally, it includes the principle of analysis method, instrument and its parameters, preparation of reagents, test solution and reference solution, etc., test process, calculation formula and range limit requirements, etc. Then, based on prior knowledge and risk assessment, conduct appropriate experimental studies (using DOE if necessary) to understand the material properties and method parameters to be controlled and their relationship to method performance to ensure method robustness and stability. Finally, develop and define a series of method conditions and controls that are expected to meet the ATP to establish a method control strategy.

(2) The second stage method performance confirmation

Method performance validation is the collection and evaluation of data and knowledge from the method validation phase to establish evidence that the method provides high-quality analytical data. Only validated methods can be used for the inspection of materials and products and can be used reliably for the intrinsic quality control and process analysis of products.

（3）Continuous method confirmation in the third stage

The purpose of continuous method validation is to continuously ensure that established analytical methods remain in a controlled state during routine use. Specifically, it includes the implementation of periodic inspection and review, change control and re-validation. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of GMP workshops, purification workshops, sterile rooms, microbiology laboratories, and clean engineering consulting, planning, design, construction, installation and transformation.

The application of analytical method life cycle management can promote the continuous compliance of test methods with regulatory and technical requirements during the life cycle, achieve quality assurance for testing activities throughout the product life cycle, and improve product manufacturers' confidence in quality control data .

2. Analysis method validation process and documents

Method users should formulate management procedures for method validation, validation and transfer, clarify the responsibilities and technical requirements for method validation, and have clear and specific guidelines for the drafting, review, approval, implementation, reporting and management of validation documents of the method validation program Provisions.

Corresponding method validation should be completed before the analytical method is formally used for GMP release; the formal analytical method validation should use validated equipment.

Method validation and validation activities required by GMP should be planned in advance, and the scope and extent of validation and validation should be detailed in the GMP clean pharma machinery validation plan or similar documents. The verification plan will specify the timing of the verification activities, the arrangement of personnel, and the necessity to carry out the relevant verification activities; the tasks and responsibilities of the members of the verification team are clearly defined. Method validation activities should be performed by trained personnel with validation capabilities in accordance with approved validation procedures and protocols. Important validation documents include the method validation plan, the method validation protocol, and the original method validation records and reports.

The extent and extent of method validation or validation is determined by a risk assessment. According to the impact of the method on product quality evaluation, the verification degree will be determined according to the source of the method and the risk of the scope of use of the method for the method that requires formal verification of GMP. For methods that do not require formal validation of GMP, adequate GMP clean pharma machinery control strategies and tools should be employed to ensure that the method consistently provides accurate, reliable data.

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