Serodos and Serodos plus

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1 Design Verification Serodos and Serodos plus Contents 1 Value Adjustment Target Determination Stability... 2 Real-Time Stability... 3 Stability after Reconstitution... 4 Stability after Reconstitution and Storage at 20 C for one Month Result Documentation Traceability... 5 Form: /5 CS-SE valid of

2 1 Value Adjustment The liquid raw material is tested by the quality control for the content of each individual parameter. If necessary, respective parameters are spiked or stripped to meet the specification for normal, elevated or pathological range. The values for each parameter are checked again after lyophilisation. If all parameters comply with the specifications, the target value assignment is started. 2 Target Determination The target value determination of HUMAN s control sera SERODOS is performed by own QC laboratories and external laboratories employing different methods and instruments. The assigned target values for each parameter reflect the consensus valuex, obtained by statistical evaluation of the results of all participating laboratories. 3 Stability The shelf life of SERODOS and SERODOS plus has been confirmed by the results of real-time studies. Each lot of control serum is checked by temperature stress studies at the time of production. Retained samples of each batch are further tested at suitable intervals in order to monitor real-time stability during the assigned shelf life. SERODOS and SERODOS plus have an assigned shelf life of 4 years from the date of production. Data have been established during the design development and are secured by stress tests on each production batch. In parallel, each lot will be retested at the end of the expiration date to verify stability. Storage and Stability: Stability of the components in the reconstituted controls (see Limitations below): at 25 C at least 8 hours at C organics and anorganics at least 10 days; enzymes 7 days at -20 C at least 1 month (when frozen once) Limitations: Stability of Bilirubin in the reconstituted control serum when stored protected from light (in brown amber glass): at C 4 days Do not store at 25 C! Do not freeze! For Total and Prostate Specific Acid Phosphatase the reconstituted material should be stabilised by adding one drop (25-30 µl) of acetic acid (0.7 mol/l) to 1 ml of the controls. Stability of stabilised Acid Phosphatase: at 25 C 2 hours at C 2 days at -20 C 1 month (when frozen once) Alkaline Phosphatase levels will rise over the stability period after reconstitution. The reconstituted control should be allowed to stand for 2 hour at 25 C before measurement. Store controls tightly capped when not in use. Design Verification and Product Data for SERODOS AND SERODOS PLUS 2/5

3 Real-Time Stability Below typical stability data on some constituents are summarised. The data compare results obtained from realtime storage (2...8 C) and deep-frozen storage (-80 C). SERODOS Freshly produced Check dates Raw material lot UN Established Unit 4 C -80 C % DEV 4 C -80 C % DEV target ALBUMIN 42.2 g/l % % ALK. PHOSPH. 295 U/l % % GPT (ALT) 54 U/l % % a-amylase 97 U/l % % GOT (AST) 55 U/l % % CALCIUM 2.29 mmol/l % % CHOLESTEROL 4.18 mmol/l % % CK NAC-act. 193 U/l % % CHLORIDE 98 mmol/l % % CREATININE 141 µmol/l % % DIRECT BILIRUBIN 12.1 µmol/l % % GAMMA-GT 55 U/l % % GLUCOSE 6.27 mmol/l % % INORG. PHOS mmol/l % % IRON 19.2 µmol/l % % POTASSIUM 3.95 mmol/l % % LDH 416 U/l % % MAGNESIUM 0.92 mmol/l % % SODIUM 143 mmol/l % % TOTAL BILIRUBIN 21.8 µmol/l % % TOTAL PROTEIN 59.5 g/l % % TRIGLYCERIDES 1.24 mmol/l % % UREA 7.47 mmol/l % % URIC ACID 0.35 mmol/l % % SERODOS Freshly produced Check dates Raw material lot UE Units 4 C -80 C % DEV 4 C -80 C % DEV ALBUMIN 30 g/l % ALK. PHOSPH. 515 U/l % GPT (ALT) 124 U/l % GOT (AST) 157 U/l % CALCIUM 3.27 U/l % CHLORIDE 118 mmol/l % CK-NAC 456 mmol/l % CREATININE 329 U/l % GAMMA GT 202 mmol/l % GLUCOSE µmol/l % INORG. PHOS 2.31 µmol/l % LDH 677 U/l % AMYLASE 333 mmol/l % MAGNESIUM 1.76 mmol/l % CHOLESTEROL 7.61 µmol/l % TRIGLYCERIDES 2.7 mmol/l % IRON 39.2 U/l % TOTAL PROTEIN 46.1 mmol/l % TOTAL BILIRUBIN 71.5 µmol/l % DIRECT BILIRUBIN 27.1 µmol/l % UREA g/l % SODIUM 166 mmol/l % Uric Acid 0.57 mmol/l % POTASSIUM 6.3 mmol/l % % Design Verification and Product Data for SERODOS AND SERODOS PLUS 3/5

4 SERODOS Freshly produced Check dates Raw material lot UE Established Unit 4 C -80 C % DEV 4 C -80 C % DEV target ALBUMIN 29.8 g/l % ALK. PHOS 524 U/l % GPT (ALT) 131 U/l % AMYLASE 376 U/l % GOT (AST) 141 U/l % CALCIUM 3.13 mmol/l % CHOLESTEROL 111 mmol/l % CK-NAC 7.38 U/l % CHLORIDE 473 mmol/l % CREATININE 338 µmol/l % DIRECT BILIRUBIN 20.5 µmol/l % GAMMA-GT 197 U/l % GLUCOSE 16.4 mmol/l % INORG. PHOS 2.19 mmol/l % IRON 37.5 µmol/l % POTASSIUM 6.03 mmol/l % LDH 711 U/l % MAGNESIUM 1.75 mmol/l % SODIUM 158 mmol/l % TOTAL BILIRUBIN 62.1 µmol/l % TOTAL PROTEIN 43.3 g/l % TRIGLYCERIDES 2.63 mmol/l % UREA 19.5 mmol/l % URIC ACID 0.57 mmol/l % Conclusion: The real-time stability data obtained observed from 3 independent lots over a period of 4 years confirm the stability claim of 4 years. Stability after Reconstitution The stability after reconstitution has been checked at storage conditions C and 25 C. The data are summarised below (units and parameters follow the above scheme). SERODOS plus Check dates Raw material lot 272UECM/2 Storage at C Storage at 25 C Parameter Established 4 days % DEV 7 days % DEV 8 hours % DEV target, units as above ALBUMIN % % % ALK. PHOSPH % % % GPT (ALT) % % % a-amylase % % % GOT (AST) % % % CALCIUM % % % CHLORIDE % % % CHOLESTEROL % % % CK NAC-act % % % CREATININE % % % DIRECT BILIRUBIN % % % GGT % % % GLUCOSE % % % IRON % % % LDH % % % LITHIUM % % % MAGNESIUM % % % INORG. PHOSPH % % % POTASSIUM % % % SODIUM % % % TOTAL BILIRUBIN % % % TOTAL PROTEIN % % % TRIGLYCERIDES % % % Design Verification and Product Data for SERODOS AND SERODOS PLUS 4/5

5 UREA % % % URIC ACID % % % Conclusion: The claimed stability after reconstitution is confirmed. Stability after Reconstitution and Storage at 20 C for one Month The data are summarised below (units and parameters follow the above scheme). SERODOS plus Storage at -20 C Raw material lot 281UE/1 Parameter Established target, units as above 1 month %DEV ALBUMIN % ALK. PHOSPH % GPT (ALT) % a- AMYLASE % GOT (AST) % CALCIUM % CHLORIDE % CHOLESTEROL % CK NAC-act % CREATININE % DIRECT BILIRUBIN % GAMMA-GT % GLUCOSE % IRON % LDH % LITHIUM % MAGNESIUM % INORG. PHOSPH % POTASSIUM % SODIUM % TOTAL BILIRUBIN % TOTAL PROTEIN % TRIGLYCERIDES % UREA % URIC ACID % Conclusion: The claimed stability after reconstitution and storage at 20 C for one month is confirmed. 4 Result Documentation For each batch of SERODOS quality control sera a leaflet is created which contains information on reconstitution, handling, stability, target values and permitted ranges for all specified parameters. 5 Traceability The assigned target values of SERODOS quality control sera are traceable to reference methods (i.e. IFCC) or reference materials (i.e. NIST), if applicable. Design Verification and Product Data for SERODOS AND SERODOS PLUS 5/5

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