Material Status Indication
Introduction
This document provides guidance on status control of the following materials:
- Raw Materials (RM);
- Starting Materials;
- Packaging Materials including labeling;
- In-Process Materials;
- Drug Products;
- Intermediates;
- Medical Devices;
- Components;
- Active Pharmaceutical Ingredients (API);
- Returned Goods, including Recalled product;
- Materials determined to be Acceptable for Rework/Reclaim;
- Rejected Materials; and
Materials with Direct or Potential Indirect Product Contact, including cleaning materials and other items.
Colors to be used for status labels, signs, chains, shrouds, or painted areas intended for visible status indication should be defined in a Site Standard Operating Procedure (SOP). Determination of the colors to be used should include consideration of historical, cultural, or intuitive color choices and designation (i.e. green must not be used to indicate “rejected” or “quarantine”, and red shall not be used to indicate “approved”). The colors defined in the Site SOP should be used consistently across the Site.
Dedicated Status Locations for Rejected, Recalled, or Quarantine-HOLD Materials should be used in addition to the use of status labels on each container, and if not bounded by permanent walls, the areas must:
- Be clearly defined by signs;
- Be bounded by colored lines or chains (e.g., supported by wall hooks or portable stanchions), or by colored netting or tarpaulins that cover the material;
- Exclude material of any status other than that designated; and
- Be separated from other status-designated areas by at least one pallet width; or
- If space limitations prohibit the pallet-width separation, barriers must be used that physically prevent movement of any containers into or out of the dedicated area.
All Status Labels should be placed on containers in a manner that is readily visible, and should never to be applied to pallets or to container lids. Approved status labels should not be required to be used on finished drug products, finished APIs, finished medical devices, in-process materials or intermediates.
In lieu of labeling each container, status labels should be applied to at least two sides of the unitized pallet containing the drums/containers. The unitized pallet should be shrink wrapped or covered with a shroud such that individual containers cannot be removed.
All Status Label Sizes and Shapes should be square or rectangular and the same size except for sampled status labels, which may be smaller. Alternative measures for use of status labels, except for Rejected and Sample status labels may be used. Additional points regarding use of status labels, include:
- Standard size may vary from Site-to-Site;
- Print size may vary, but must clearly display status;
- Validated bar-coding systems can be used to augment status labeling, as long as status is clear and visible;
- Approved status labels are not recommended for finished API packaging or drug product or medical device shippers; the action would require peelable labels, which tend to fall off containers. In addition, when materials are transferred to another Site, such status becomes misleading; and • Label entries are made prior to application, unless otherwise authorized by the responsible Quality Team.
Newly Received Material should be inspected, have all status indication labels or labeling immediately defaced or removed, and promptly provided new status indication/protection. The quantity of material received and assigned to a status should be recorded.
Labels Marked “Sampled” should be used to identify each container that has been sampled. The container should be numbered to identify from which container each sample was taken. Bar-coding with human-readable text may be used.
Rejected Material should be physically isolated in dedicated materials status areas, and its status clearly identified by label.
Status Labels Signifying Rejected Status should be applied to each container of the lot involved within twenty-four (24) hours after the material status has been defined. Such status labels should be of non-peelable stock. If the Rejected status label cannot be applied within twenty-four (24) hours, an acceptable temporary [less than twenty-four (24) hours] alternative is the use of suitable shrouds (e.g., shrouds labeled Rejected).
In lieu of labeling each container, status labels signifying Rejected status may be applied to at least two sides of the unitized pallet containing the drums/containers
within twenty-four (24) hours after the materials status has been defined. A pallet of containers may be unitized by shrink wrapping or covered with a shroud such that individual containers cannot be removed.
In Automated Warehouses, where status indication of racked materials is controlled by barcodes and validated computerized systems:
- Approved and Quarantine materials do not require visible status indication;
- Rejected material should be removed within twenty-four (24) hours of status assignment to a dedicated material status area and provided visible status indication; and
- Quarantine-HOLD material should be removed within twenty-four (24) hours of status assignment to an isolated Quarantine-HOLD area and provided visible status indication.
- Rejected and Quarantine-Hold materials may remain within an automated warehouse where status indication of racked materials is controlled by barcodes and validated computerized systems when the following special conditions are met.
- Visible status indication is applied as soon as rejected materials leave the automated warehouse for on-site disposal or waiting to be shipped for off-site destruction;
- If only a portion of the lot is rejected then the status label should be applied within twenty-four (24) hours of status designation;
- Extra security measures are applied through a combination of programming and administrative controls that isolate Rejected and Quarantine-Hold material from normal warehouse transactions and authorize only a limited number of qualified individuals to move such materials; and
- All extra security measures are clearly identified in procedures, validated, and approved by the Quality Team.
When Status of a Material is Changed, the quantity of material being assigned to a status should be documented.
R&D Materials, when stored in non-R&D (Research & Development) areas, should follow the same status indication standards. When such materials are in areas that also contain production materials, additional color-coded status labels (e.g., “Research & Development Material”) may be used alongside the standard status labels for additional status indication. Alternatively, R&D materials should be totally isolated.