Sampling

Question 1

What sampling STD usually applies to receipt testing? What would be a limit for a critical reject?

Answer 1

ISO2859 used to define number of samples and defect allowances. Should not allow and critical defects

Question 2

What statistics do you use for incoming materials?

Answer 2

AQLs

Question 3

What are the limitations of AQL’s?

Answer 3

Only taking a sample, acknowledging risk or accepting poor quality and rejecting good quality

Question 4

Delivery 25 drums, 20 pass, 5 failed what would you do?

Answer 4

Quarantine drums, carry out OOS investigations. If true result raise a supplier complaint. If critical medicine is there a way of a mixed decision e.g. 5 failed at start or end of batch, supplier confirmed intervention before or after failed drums was responsible for the change in quality. Look for strong capas from suppliers and document in supplier management system. Maybe look to bring forward planned audit. Potentially look for another supplier

Question 5

Quarantine drums, carry out OOS investigations. If true result raise a supplier complaint. If critical medicine is there a way of a mixed decision e.g. 5 failed at start or end of batch, supplier confirmed intervention before or after failed drums was responsible for the change in quality. Look for strong capas from suppliers and document in supplier management system. Maybe look to bring forward planned audit. Potentially look for another supplier

Answer 5

Use a lot of control charting with UCL and LCL 3 SD from the mean. Look to put alert limits at say 2 SD to give early warning signals but this is dependent on how capable the product is so any action and alert limits should be set through risk assessment after reviewing all available data

Question 6

What standard would you use to set a sampling plan for a delivery of bottles?

Answer 6

I would use ISO2859 and use general inspection level 2 and my lot size to define my sample size and acceptable defect level

Question 7

What are the categories of sampling defects?

Answer 7

Minor, major and critical

Question 8

Name some examples of minor defect types?

Answer 8

A minor defect is one where the item deviates slightly from your specifications, but it’s still saleable and unlikely to trigger a return. e.g. smudge on artwork that doesn’t obstruct critical information, Visual defects which do not affect the use or elegance - compare to visual standard, Clarity is not as per specification, Diameter is under or exceed specification, Thickness is out of specification, Packaging material code incorrect or not in the exact position, Defaced

Question 9

Name some examples of major defect types?

Answer 9

A major defect is one that makes your product unsaleable or likely to be returned by the consumer e.g. Seals not present, Missing non critical component such as a poly liner, Wrong delivery quantity, Pin hole in no- sterile, pitting, scuffing, streak, nicks, embedded foreign matter, splits, Water damaged outer packaging, Gloss free area missing, Visual defect which affects the use or elegance, Anti-counterfeit labels are not in the quantity specified, not positioned as per artwork / are easily removed, Colour is out of colour standard, Barcode / EAN / Pharmacode is incorrect, unreadable or in the incorrect position, Spelling is incorrect

Question 10

Name some examples of critical defect types?

Answer 10

A critical defect is one that could cause injury to the consumer or even — in extreme cases — death e.g. breach in sterile barrier, delivery damaged, safety seal missing, missing or unreadable critical data

Question 11

What 2 guidelines would you reference for sampling?

Answer 11

Chapter 8 and ISO2859

Question 12

The Sampling Procedure
Should detail, amongst other things:

Answer 12

• The Sampling Plan
  ➢ Plus associated AQLs
• The Sampling Method
  ➢ Including special precautions
• The Sampling Equipment
• The Sampling Environment
  ➢ Avoidance of cross contamination
• The Sample Containers
  ➢ Numbers
  ➢ Types
  ➢ Size
  ➢ Other requirements (e.g. sterility)
• Labelling Requirements
  ➢ For samples and bulk
• Storage Requirements
• Documentation

Question 13

Sampling Plans

Answer 13

The number of samples to be taken is usually determined using a sampling plan based on ISO 2859.
This is a set of sampling plans that have a sound statistical basis.
ISO 2859 provides a collection of Sampling Plans indexed by:
* Sample size code letter
* Acceptable Quality Level (AQL)
A Sampling Plan indicates the number of units of product from each batch which are to be inspected
and the criteria for determining the acceptability of the batch.
The number of samples to be inspected is determined by the batch size and the inspection level to be
used: the usual starting level is General Inspection Level II.