Representative and correct sampling is an essential requirement for obtaining valid results in laboratory testing. Tests to determine safety, quality, contents and compliance with official requirements, for example, are of no value if the sampling is carelessly performed.GMP contains ten principles that introduces employees to critical behaviors established by FDA and industry leaders to maintain good manufacturing practices in plants.
Proper Sampling Protocol (Testing for Microorganisms)
1. Sampling Plan
Determine ahead of time if an International Standard (ISO, IDF, AOAC, etc) applies to the product concerned. If there are none, it is recommended that the parties concerned come to an agreement on the subject. It is equally important that the lab receive a representative sample that has not been damaged or changed in transport or storage.
Transport of the samples to the laboratory shall ensure they are kept under conditions which prevent any modification in the number of microorganisms present. Give preference to those means of transport which offer fastest transportation times while observing the following storage temperatures:
3. Receipt and Storage
Stable productstransport at ambient temperature
Fresh and refrigerated products0°C to +4°C
Frozen or deep-frozen productsbelow -18°C
Pasteurized and similar products0°C to +4°C
Spoiled products*0°C to +4°C
*Make sure that spoiled units are shipped in closed packaging for protection against leakage.
Upon receipt of the samples, the laboratory must check the condition of the product. If the condition is unsatisfactory or if there is an insufficient quantity of the sample, the laboratory should either refuse the samples or have reservations about any sampling results.
Any samples admitted to the lab must be
referenced so they may be tracked until the test report has been drafted. The following information must be noted:
Date of receipt
Characteristics of the sampling operation
(sampling date, conditions, etc.)
Requesting partys name and address
Characteristics of the product
While samples are awaiting examination, particular attention should be paid to the storage temperatures and examination deadline:
4. Test Portion
Stable products: as early as possible before
storage limit date
Fresh and refrigerated products: within 24 hours after receipt (if longer storage cannot be avoided, freeze sample ASAP at temperature below -18°C and note in test report since freezing may modify composition of flora).
Pasteurized or similar products: as early as
possible before storage limit date
Spoiled units: 48 hours
Avoid contamination of the environment and test portion by: (a) working in special premises or in safety cabinet and (b) handling the samples in such a manner as to avoid any and all risk of contamination. To achieve this, take the following precautions:
For packaged products, clean outside of packaging at the place it will be opened with 70% alcohol solution. Flame is possible.
Any instrument used to open the package should be sterile.
Carefully mark the reference of the lab sample
on the container, plastic bags, etc. enclosing the test sample.
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