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Continuous Flow Mfg Skip-Lot Sampling

Continuous Flow Mfg Skip-Lot Sampling. Domenick Amato Frank Gomez Lynn Torbeck. 210.3(20) “Acceptance Criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level with an associated sampling plan …”

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Continuous Flow Mfg Skip-Lot Sampling

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  1. Continuous Flow MfgSkip-Lot Sampling Domenick Amato Frank Gomez Lynn Torbeck

  2. 210.3(20) “Acceptance Criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level with an associated sampling plan …” 210.3(21) Representative samples 21 CFR 210.3

  3. Requirements: Representative samples Number of containers to sample Amount of material to be taken Variability – Process average Confidence levels Past quality history 21 CFR 211.84

  4. How to define a continuous process? Types of processes? How to define a “lot” or “batch” in a continuous flow process? Assumption of homogeneity of product? Assumptions about defects? Continuous Flow Mfg

  5. Variables Plans: ANSI/ASQ Z1.9 Attribute Plans ANSI/ASQ Z1.4 ISO 2859 Types of Sampling Plans

  6. Population of units, lots or batches AQL: Acceptable Quality Limit LQ: Unacceptable Quality Limit Sample size Accept number Reject number Sampling Plans Defined

  7. “Producer’s Risk” The probability that a good lot is rejected by the customer. (Type I error or alpha) “Consumer’s Risk” The probability that a bad lot is accepted by the customer. (Type II error or beta) Levels not fixed but common values are 5% and 10%. Risk Management

  8. Representative samples Beginning, middle and end Top, middle and bottom Every 30 minutes or 100 units Random Sampling – (difficult) Defects must be randomly distributed ! Sample inspection is 100% Assumptions for Sampling

  9. Smaller sample size. Using General Inspection Level I in place of Level II or III in Z1.4. Not inspecting all characteristics on the CoA or listed in the USP. Can use reduced testing in Z1.4. Use the switching rules in Z1.4. Reduced Testing

  10. Not all lots are tested. Only a fraction of lots are inspected. Goal is to save money or time and still achieve quality products. Skip-Lot Sampling

  11. Test every “nth” lot, not random. Test “i” lots, if all pass go to a fraction, “f”, of future lots. Select i and f in advance. Lots selected at random. ASQ S1, i and f are determined from the data collected. Lots are selected at random using dice. Types of Skip-Lot Sampling

  12. Supplier and customer agree on a plan. Good communications. Faith and trust in an honest supplier. Good relations. Proven history of quality with a stable and continuous process. Clear criteria for action plan. Assumptions for Skip-Lot

  13. Compendial requirements Regulatory expectations Current state, pro/con/concerns Desired state for excipients Fraud, counterfeiting, adulteration Processes “Out of control.” Changes without notification Discussion Topics

  14. NIST http://www.itl.nist.gov/div898/handbook/pmc/section2/pmc22.htm http://www.itl.nist.gov/div898/handbook/pmc/section2/pmc27.htm http://www.itl.nist.gov/div898/handbook/pmc/section2/pmc23.htm ASQ (1996). ANSI/ASQ S1, “Attribute Skip-Lot Sampling Program.” Schilling, E. (1982). Acceptance Sampling in Quality Control, New York, NY: Marcel Dekker, pp 443-451 Juran, J. and Godfrey, A. (1999). Juran’s Quality Handbook, Fifth Edition, pp 46-31, 46-32, New York: McGraw Hill. References

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