This SOP establishes procedures for documenting the review and disposition of materials which are either in process or in inventory and are found to be nonconforming, i.e. which fail to meet established specifications for identity, purity, composition, or quality or which are otherwise unsuitable for use (e.g. contaminated).
21 CFR 111 requires that whenever there is reason to doubt whether a material meets specifications or is otherwise unsuitable for use, or when there has been any deviation from normal procedures, the quality department must conduct a material review and decide the disposition of the material (e.g. 21 CFR 111.113).
This procedure QA-9030 is intended primarily to document the existence and disposition of a material that has been found to be definitely nonconforming. An investigation to determine whether or not a material is nonconforming is generally handled under other SOPs, such as QA-9010 (Unplanned Events), QA-9110 (Out-of-Specification Investigations), or QA-9220 (Returned Goods).
Examples of issues which might be documented using this SOP include:
- A lot of raw material is found to contain less than the specified amount of a particular constituent (e.g. a vitamin, mineral, or botanical marker compound).
- A lot of raw material is found to contain lead at a level in excess of the specified limit.
- The mesh size of a powder is smaller than specified.
- A shipment of labels is found to have been misprinted.
- In-process testing of a granulate reveals solvent levels in excess of the in-process specification.
- A batch of finished product is found to contain pathogenic bacteria.
- A batch of tablets is found to have been compressed at the wrong weight.
- A batch of product is found to have been labeled with the wrong batch number.
- A portion of a capsule batch is found to have been contaminated with machine oil.
- A portion of a lot of raw material is found to have been infested with insects.
The form can be used to document the disposition of nonconforming materials as required by 21 CFR §111.90. The report should be filed with the other records for the batch or lot. In addition, a copy should be filed in the QA department to facilitate periodic review of NCMR trends.
The log can be used to track nonconforming material reports. Details about each NCMR, including the disposition of the material, should be recorded on a Nonconforming Material Report.