10. Guideline For The Submission Of Analytical Method Validation (AMV) Documents

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10.1 TYPES OF ANALYTICAL PROCEDURES TO BE VALIDATED

 

  • Identification tests
  • Quantitative tests for impurities' content
  • Limit tests for control of impurities
  • Quantitative tests of the active ingredient in the sample (assay and dissolution)
  • Pyrogen or Bacterial endotoxin test
  • Sterility test
  • Microbial Contamination Test
  • Biological Assay of Antibiotics

10.2 TYPICAL VALIDATION PARAMETERS FOR CHEMICAL TESTS

          10.2.1        FULL VALIDATION FOR IN-HOUSE METHODS

 

TABLE IX:

Characteristics

Type of Analytical Method

Identification

Testing for Impurities

 

Assay:

      • dissolution (measurement only)
      • content/ potency

 

Quantitation

Limit

Accuracy

 

 

Precision Repeatability
Interm. Precision

 

 


     √ (1)

 

 


     √ (1)

Specificity (2)

Detection Limit

 

(3)

 

Quantitation Limit

 

 

 

Linearity

 

 

Range

 

 


10.2.2      PARTIAL VALIDATION FOR COMPENDIAL/PHARMACOPOEIAL METHODS

 

TABLE X:


Characteristics

 

Type of Analytical Method

Identification

Testing for Impurities

Assay:

        • dissolution (measurement only)
        • content/ potency

Quantitation

Limit

Precision
Intermediate Precision

 

 

(1)

 

 

(1)

Specificity (2)

Detection Limit

 

(3)

 

Quantitation Limit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Note:

√          signifies that this characteristic is normally evaluated.

(1)       In cases where reproducibility has been performed, intermediate precision is not needed.

(2)       Lack of specificity of one analytical procedure could be compensated by other supporting analytical procedure(s).

(3)       May be needed in some cases.

 

 

10.3 TYPICAL VALIDATION CHARACTERISTICS FOR MICROBIOLOGICAL TESTS:

Table XI:


Microbiological tests

Validation characteristics

Bacterial Endotoxin Test

  • Test for Confirmation of Labelled Lysate Sensitivity(Verification of criteria for standard curve)
  • Test for Interfering Factors (Inhibition/ Enhancement tests)

Sterility Test

Validation (Bacteriostasis or Fungistasis) Test

  • Quantity of Sample/ Volume of Sample
  • Membrane filtration/ Direct inoculation
  • Open System or Closed System (if uses Membrane filtration method)
  • Volume of rinsing fluid

Microbial Contamination Test

  • Validation of total viable aerobic count (suitability of the counting method in the presence of product) 1 batch
  • Validation of test for specified microorganism (suitability of the test method) 1 batch

Microbiological Assay of Antibiotics

Linearity of the dose response relationship

Note:

  • All the analytical validation done by the industry should be in accordance to ASEAN Guidelines for Analytical Procedures, ICH Technical Requirements for Registration of Pharmaceuticals for Human Use under Validation of Analytical Procedures: Text and Methodology Q2 (R1), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), or Japanese Pharmacopoeia (JP).
  • The applicants should ensure all documents available in the online Quest system are of the latest versions. All correspondence on the protocol of analysis and analytical method validation should comply with any relevant circulars regarding the registration process. Failure to do so may cause cancellation or rejection of product registration.

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