Glossary

Average sample:

Sample that represents an (local) average of a product. Has not to be homogeneous if the main quantitiy is not homogeneous..

Collected sample

Mixed sample.

Contamination

Pollution e.g. with dust, bacteria, pulp, wood chips, hair, bugs or other. When sampling special care has to be taken that neither the samples nor the main quantity is contaminated.

Cross contamination
Pollution with a different product. This can easily happen when sampling different products one after the other and no or insufficient cleaning of the sampler takes place or through clothing of personnel.

Documentation
Both the general procedure of sampling and each execution of sampling has to be documented adequately.

GMP

(= Good Manufacturing Practice) GMP is a term that was introduced by the US Authority Food and Drug Administration (FDA) in 1962. It's synonymous for a compilation of measures and instructions that have to be respected when producing specific products (e.g. pharmaceutical, foodstuff, cosmetics). Its target is to manufacture these products reliably and reproducible in the desired quality.

The commitment to respect the GMP guidelines arises from respecting the laws or by international agreement (e.g. PIC = Pharmaceutical Inspection Convention)

Heterogeneity

In-Homogeneity: dissimilarity within a product caused by diverse influences. Causes are often contamination, changes of temperature, vibrations, insufficient mixing, flotation and sedimentation.
Detection of In-Homogeneity:
On the basis of a defined sampling schedule take many small samples from the product, analyze separately, assign average M of the results and its relative uncertainty u rel .

If u rel is higher that the combined relative uncertainty of measurement of the single analysis a significant in-homogeneity exists.

Possible routine measures:
- include u rel as an addititional component in the uncertainty of measurement.
- Prescribe the same procedure for each analytical sample according to the sampling schedule. All single analyses are carried out and the In-Homogeneity is included in the report (all differing single results are shown) - Sampling as above then creation of a mixed sample, which is analyzed.

Homogeneity

Uniformity of a product regarding one or several features but not necessarily all features. Also see: Heterogeneity .

Hygiene

Rules that have to be respected as soon as work on the opened product has commenced e.g. during sampling.
Garment instructions (overalls, caps, masks, gloves etc.) are related to hygiene as well as personal behaviour next to the open product such as not eating, smoking, sneezing or coughing, scraping or bending over the product.

Labeling

Both the samples and the sampled containers have to be labeled in order to ensure retraceablility. The labeling must be readable, unique and durable (no Post-it).

Location of sampling

Ideally a special room or cabin should be available for the sampling. The sample should be withdrawn in a clean surrounding where the risk of environmental influences on the sample is minimised. If sampling is done frequently, it should be executed always in the same place.

Mixed sample

A mixed sample can be created by collecting and mixing multiple single samples. See also: Collected Sample.

Qualification

Certified approval of suitablility of devices, facilities, equipment, and also personnel and suppliers.
Qualification is a prerequisition for validation.

Random sample

A partial quantity that is representative to the main quantity regarding the composition, characteristics and features to be examined.
The correct sampling is an essential part of the quality control system. The number of the samples to be withdrawn should be result of statistical thoughts and be defined in the sampling schedule.

Reproducibility

At what extent can the results be reproduced when the sampling and analysis is conducted on different days by different personnel, different devices, different laboratories?

Retain sample

Samples that are not analyzed directly but serve as conservation of evidence (demand e.g. in pharmaceutical industry).

Sample dividing

Procedure to create representative analytical samples out of huge mixed or single samples. Analytical samples are often only a portion of the initially withdrawn samples.

Sample preperation

Methods to prepare the withdrawn samples for the respective laboratory analysis. Sample dividing can also be understood as part of the sample preparation.

Sampling personnel

Trained person, who is able to withdraw the samples including the documentation according to the SOP. The personnel has to be aware of the importance of their operations regarding GMP (representative samples) but also regarding safety.

Sampling schedule

Standard operation procederes (SOP's) constitute extent, location, apparatus, containers and labeling of sampling. If possible sampling schedules should be based on adequate statistical methods. Factors that influence the results of the examination are taken into account in the sampling schedule.

It's the discretion of the plant to define the extent of sampling depending on the risk and the quality targets. To do so random numbers can be used. It's more efficient to check 2 samples from one line every day than to check 5 one time a week from a charge. Sampling schedules are generally specific to the product. Sampling schedule and SOP should be available on site.

Self inspection

Auditing of the operations of a plant that produces and controls pharmaceuticals is called self inspection . Apart from national regulations the guidelines of the FDA to supervise the production of pharmaceutical products and ingredients have to be respected. These inspections detect weakness in the quality control system and in the daily routine. The frequency and documented GMP self inspections are regulated in diverse national and international laws.

Single sample

A sample, that will be withdrawn by a single action. A single sample can also be an average sample as it can be obtained e.g. with the Multi-Layer sampler.

SOP

Standard Operation Procedure. Approved instruction that has to be respected by all collaborators - or all involved. Any deviation from the SOP has to documented and justified.

Swab test (swab sample)

Sample that is obtained by swabbing, e.g. to check the result after a cleaning process.

Target sample

Sample that is withdrawn from a specific location defined in the sampling schedule.

UDS

Unit Dose Sampling - common sampling procedere in the pharmaceutical industry to ensure the blend uniformity. Only small samples are withdrawn that represent up to 3 times of the unit dose.

Validation

Validation in general is the generic term for all activities that shall test the suitibility of quality-relevant operations.
In the narrow sense validation is the documented approval of the suitability of a method, e.g. a method of analysis, a manufacturing method, a cleaning method for a specific purpose. There is no patent remedy for validation programs, validation always has to take place problem-oriented and pragmatically.

Validation of sampling

The validation has to produce evidence that the sampling is suitable to generate representative sample in terms of a specific question regarding the product.

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