TEST METHOD AND METHOD VALIDATION

KAN-TN-LP 02 Issue Number : 3 April 2016 Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded 4

4. TEST METHOD AND METHOD VALIDATION

a. The test method are adequately documented are based on the latest valid edition of a published reference method, including : i. Title and method number, ii. Scope and field of application, iii. Number of revision, iv. Page numbering, total number of pages, v. References, vi. Principles and definitions, vii. Reagents and materials, viii. Apparatus, ix. Analytical methodology, x. Expression of results, xi. Performance criteria, xii. Storage and shelf-life, xiii. Procedures for media preparation, xiv. Procedures for maintenance of stock cultures, xv. Procedures of safety for media handling, xvi. Quality control, xvii. Colony counting if applicable, xviii. Reporting criteria, xix. Issuing authority. b. The microbiological test method number and title used in the laboratory shall the same as the scope of testing when carry out assessment for accreditation. c. The validation of microbiological test methods should reflect actual test conditions. This may be achieved by using naturally contaminated products or products spiked with a predetermined level of contaminating organisms. KAN-TN-LP 02 Issue Number : 3 April 2016 Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded 5 d. The validation of microbiological test methods needs for non-standard methods and laboratory-developed methods. This activity is planned and assigned to qualified personnel. e. The method’s performance characteristics are based on the intended use of the method. Method that used for qualitative microbiological test analysis there does no need validate the method’s linearity over the full dynamic range of the equipment. f. Qualitative microbiological test methods, when the result is expressed in terms of detected not detected and confirmation and identification procedures, should be validated by determining, if appropriate, the specificity, relative trueness, positive deviation, negative deviation, limit of detection, matrix effect, repeatability and reproducibility. g. Quantitative microbiological test methods, the specificity, sensitivity, relative trueness, positive deviation, negative deviation, repeatability, reproducibility and the limit of determination within a defined variability should be considered and, if necessary, quantitatively determined in assays. h. Determination of microbiological test methods performance characteristics for the validation of non-standard and laboratory developed methods recommended following : i. Meet method system suitability requirements, if applicable. The suitability of the method is checked and confirmed by comparing with requirements typical for the intended use of the method. Such as, a filtration method for a non- filterable food, surface tests for Colony Forming Units square area where CFUgram is needed. ii. Include un-inoculated medium control to assess contamination from the laboratory. This control is considered a blank and is to exhibit no growth. KAN-TN-LP 02 Issue Number : 3 April 2016 Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded 6 iii. Prepare and analyze positive and negative culture controls. Negatives control is a typically negative or no growth and the positive control is positive or shows microbial growth. iv. Spike positive culture control is prepared and analyzed. This assesses the matrix effects as well as the sensitivity of the method. It is recommended that a 25 gram sample be spiked with inoculums of 30 cells or less. v. Evaluate interferences. This assesses the selectivity and specificity of the method. i. Laboratory shall have: i. Written procedures for the proper collection and handling of sample and organism including personal safety and spill handling. ii. Preparation procedures, protocols and quality control programs for in-house media. iii. Procedures and records of media preparation. j. Method is validated or verified in laboratory thorough: i. Qualitative tests are based upon performance history and media QC. ii. Repeatability – estimated using a minimum of 10 replicates of a known positive sample, or duplicate data collected over a period of time. iii. Estimation of measurement uncertainty. iv. Successfully participate in participate in proficiency testing. k. Quality control programs for in-house media i. Physical appearance ii. pH checking iii. Sterility results after incubation iv. Performance checks using positive and negative control organisms l. Supporting work instructions shall available to: i. Work instructions for sample disposal KAN-TN-LP 02 Issue Number : 3 April 2016 Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded 7 ii. Work instructions for disinfection sterilization and disposal of bio hazardous material iii. Work instructions for glassware cleaning iv. Work instructions for equipment instruction manuals v. Work instructions for computer software related data entry and approval.

5. EQUIPMENT AND MEASUREMENT TRACEABILITY