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Pharmaceuticals Sampling plans and techniques
- 1. Pharmaceuticals Sampling plansand techniques
- 2. Sampling isthe act, process, or technique of selecting a suitable sample, or a representative part of a population for the purpose of determining parameters or characteristics of the whole populations. All operations related to sampling should be performed with care, using proper equipment and tools.
- 3. Purpose of sampling: Samplingmay be required for different purposes, such as: prequalification; acceptance of consignments; batch release testing etc.
- 4. Classes and typesof pharmaceutical products and related materials: The materials to be sampled may belong to the following classes: — starting materials for use in the manufacture of finished pharmaceutical products; — Finished pharmaceutical products. — Packaging materials.
- 5. Types of samplingtools: 1.Scoops Small containers of solid materials may be adequately sampled using a spatula or scoop. 2.Dip tubes Dip tubes should be used for sampling liquid and topical products and should be made of an inert material, such as polypropylene or stainless steel. 3.Weighted containers For taking samples from large tanks and storage vessels, a container in a weighted carrier can be used. 4.Thieves Sample thieves should be used when taking samples from deep containers of solids.
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- 7. If thescoop used is too small for the sizes of particle being sampled, large particles will roll off and testing bias may be introduced. On the other hand, if the scoop is too big, an unnecessarily large sample will be obtained for a given number of increments. A scoopful of sample should be taken in a single movement and transferred to the sample container.
- 8. Avoid tapping thescoop to remove pharmaceutical product as this is likely to cause segregation of the sample.
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- 12. Sampling plans andtechniques Sampling plans and techniques means how a sample is selected from given population. WHO suggests 3 formulae of sampling for starting materials.
- 14. n Plan: Onlyused when material is assuming a uniform material from a recognized source and where there is a high degree of confidence in the source. The n plan is based on the formula n = √N +1 where N is the number of sampling units in the consignment. The value of n is obtained by simple rounding.
- 16. Examples of useof sampling plan n: (7) Consider a consignment of 40 containers of a starting material. Using the n plan, samples would be taken from seven containers selected at random. The appearance and identity of each of these seven samples is checked. If the results are concordant, the seven samples are combined to produce a single, composite sample from which an analytical sample is prepared for full testing.
- 17. The p plan: The “p plan” may be used when the material is uniform, is received from a recognized source and the main purpose is to test for identity. The p plan is based on the formula: p = 0.4 √N
- 18. Examples of useof p sampling plans: (3) Consider a consignment of 40 containers of a starting material. Assuming a uniform material from a recognized source with the main purpose of checking the identity. Using the p plan, samples would be taken from each container. The appearance and identity of each of these samples is checked. If the results are concordant, the samples are combined to produce a single, composite sample from which an analytical sample is prepared for full testing.
- 20. The r plan: The “r plan” may be used when the material is suspected to be non- uniform and/or is received from a source that is not well known. The r plan may also be used for herbal medicinal products used as starting materials. This plan is based on the formula: r = 1.5√N
- 21. Examples of useof r sampling plans : (10) Consider a consignment of 40 containers of a starting material. Assuming the material is non-uniform and/or from a source that is not well-known. Using the r plan, samples would be taken from each container. The appearance and identity of each of these samples is checked. If the results are concordant, 10 samples are selected at random and individually subjected to full testing.
- 23. Sampling plans andtechniques for finished products: As for packaging materials, sampling plans for finished products should be based on defined sampling standards such as ISO 2859 ,level II. What is AQL? AQL stands for “Acceptable Quality Limit,” and it’s an important standard that’s used in the quality control industry. It’s defined in ISO 2859 as: “The quality level that is the worst tolerable,” over the course of many inspections.
- 24. The AQL Chart:How it Works: The AQL chart is used to determine how many units should be inspected and how many defects are acceptable during your inspection. The chart is broken down into two tables. “Sample Size Code Letters.” “Acceptable Quantity Level” “General Inspection Level” is level II (also underlined). As a rule of thumb, this is the inspection level that you should use most of the time.
- 25. Example: your orderquantity is 1,500. So, it falls between 1,201 and 3,200 (underlined in the “Lot or Batch Size” column). With most consumer products, the standard AQL levels are 2.5% for major defects, 4.0% for minor defects. Going by this standard, we can see that your inspector will accept a maximum of: 7 major defects, and 10 minor defects. A shipment with 8 major defects, 11 minor defects, or 1 critical defect will fail. Your inspector now has the guidelines they need to make a pass or fail decision.
- 26. Table 1 –Sample Size Code Letters
- 28. Packaging materials Sampling plansfor packaging materials should be based on defined sampling standards, for example, ISO 2859.
- 29. Sampling of thePackaging Material: Carry out the sampling of all P.M. as per following sampling plan for VISUAL EXAMINATION from each selected boxes of all packaging material. NUMBER OF BOX RECEIVED SAMPLE SIZE Up to 150 20 151 to 280 32 281 to 500 50 501 to 1200 80 1201 to 3200 125 3201 to 10000 200 10001 to 35000 315 35001 to 150000 500 150001 to 500000 800 500001 to above 1250