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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

Continuous Flow MfgSkip-Lot Sampling

Domenick Amato

Frank Gomez

Lynn Torbeck

21 cfr 210 3
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
21 cfr 211 84
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
continuous flow mfg
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
types of sampling plans
Variables Plans:

ANSI/ASQ Z1.9

Attribute Plans

ANSI/ASQ Z1.4

ISO 2859

Types of Sampling Plans
sampling plans defined
Population of units, lots or batches

AQL: Acceptable Quality Limit

LQ: Unacceptable Quality Limit

Sample size

Accept number

Reject number

Sampling Plans Defined
risk management
“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
assumptions for sampling
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
reduced testing
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
skip lot sampling
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
types of skip lot sampling
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
assumptions for skip lot
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
discussion topics
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
references
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