Is it necessary to perform identification test of all the containers received of Raw material?

Manish    |    08-07-2017

4 Answers:

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Nandan    |    20-05-2018

If it is API my suggestion is yes ,if ingredients this may be done on composite samples 


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Pharmabuddy    |    02-02-2018

I hot a nice insight on this on USFDA's one of the post which says:

The Current Good Manufacturing Practice (CGMP) regulations address component sampling and testing primarily at 21 CFR 211.84.  These regulations require representative samples of each shipment of each lot of active and inactive component (or raw materials) to be tested to confirm the identity of the component as labeled prior to release for use in drug product manufacturing.  The regulations acknowledge that more than one test may be needed to ascertain a component’s identity.  For the purpose of this answer, a component’s identity is its chemical structure and its physical form (e.g., polymorph, solvate, and appearance) including, if appropriate, its stereochemistry or immunochemistry.  (See also ICH Q6A  and Q6B  )

The CGMP regulations do not specify the number of containers to be sampled from each received shipment.  However, 21 CFR 211.84(b) establishes the principles to be followed in designing a sampling program for components.  The requirements of this section can be summarized as follows:

  • samples are to be representative of the shipment received;
  • the number of containers sampled as well as the amount of material sampled from each container is to be based on statistical criteria for component variability, confidence levels, and the degree of precision required;
  • the sample program takes into account the past quality history of the supplier; and,
  • the sample amount is to be sufficient for the necessary analysis and reserve samples.

The first three are most relevant to the question of how many containers to sample for identity testing, i.e., representative sampling, tolerance for variability and confidence required, and past history.  (The amount needed for analysis and reserve can be readily met by sampling even one container, so the number of containers is not an important issue once the shipment’s identity is verified.) 

Unlike most component attributes, a component’s identity is generally a discrete variable, i.e., the material in the container either is or is not what the label purports it to be.  The component container’s content might differ from what the container label states due to mistakes in filling and labeling by the supplier or repacker, or as a result of the substitution of a container’s contents during distribution and warehousing before receipt by the drug product manufacturer.  Using a wrong component in processing could result in a serious public health hazard.  For these reasons, manufacturers need to develop an approach that provides a high degree of confidence that each container in each shipment contains the material purported by the label.  (See also 21 CFR 211.160(b), which requires all sampling to be representative and scientifically sound.)  The approach must account for the fact that the material’s identity must not vary from what is specified.  The past quality history of a supplier and the scope of their operations is relevant to the chance for mistakes to occur under a supplier’s control, but does not necessarily bear on what happens to a drug once it is outside the supplier’s control.

How many containers of each component from each shipment must a firm sample and test to comply with the CGMP requirements for identity testing?

The regulation at 21 CFR 211.84 requires that representative samples of each shipment of each lot shall be collected for testing.  Some manufacturers have interpreted the CGMPs to require that each container in a shipment be sampled and tested for the attribute of identity.  Testing samples from every container to determine identity may be valuable particularly for components purchased from distributors.  (Analytical equipment and methods are readily available that permit rapid, non-destructive identification of material directly in containers in a warehouse area.)   The CGMPs permit each drug product manufacturer to make its own decision as to the number of containers to sample, as long as the sampling plan is scientifically sound, leads to representative samples, and complies with the principles established at 21 CFR 211.84(b).  An important caveat applies with respect to 21 CFR 211.84:  samples are to be taken by the drug product manufacturer from containers after receipt (i.e., pre-shipment samples or so-called “piggyback” samples are generally not acceptable).

Do the CGMPs permit the identity test on a pooled, or composite, sample of multiple containers? 

The CGMPs address the issue of sample compositing directly but only in the context of individual container sampling.  Section 21 CFR 211.84(c)(4) explicitly prohibits compositing samples taken from the top, middle, and bottom of a single container when such stratified sampling is considered necessary (as might be the case when moisture content needs to be controlled, particularly when only a portion of a container may be used in a drug product batch).  The preamble for 21 CFR 211.84(c)(4) explains further that there "is no general prohibition... on compositing samples [from single containers] where such compositing would not mask subdivisions of the sample that do not meet specifications" (see 1978 preamble, par. 231).

Testing individual samples from multiple containers provides a high level of assurance and is consistent with CGMP.  Testing a composite sample for identity could satisfy the CGMP regulations (21 CFR 211.84 and 21 CFR 211.160) but only if a manufacturer demonstrates either that the detection of a single non-conforming container is not masked by compositing or that an additional test(s) routinely performed on the composite sample assures that all containers sampled contain the same material.  Thus, a purity assay on a composite sample prepared by mixing equal aliquots from each container may be acceptable provided such a test is sufficiently sensitive to reveal the presence of a single non-conforming container.


Admin    |    14-07-2017

Identification for each raw material container is required however sampling can be reduce for other test ; assay, related substances etc. as per WHO TRS 929 point n0.5.1 Identification for each raw material container is required however sampling can be reduce for other test ; assay, related substances etc. as per WHO TRS 929 point n0.5.1 http://www.who.int/medicines/areas/quality_safety/quality_assurance/GuidelinesSamplingPharmProductsTRS929Annex4.pdf?ua=1

Admin    |    08-07-2017

Identification for each raw material container is required however sampling can be reduce for other test ; assay, related substances etc. as per WHO TRS 929 point no. 5.1 http://www.who.int/medicines/areas/quality_safety/quality_assurance/GuidelinesSamplingPharmProductsTRS929Annex4.pdf?ua=1

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