3 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
Section 11 of ISO 22716 is one of the shortest sections in the standard, but it is easy to underestimate precisely because of that brevity. Waste handling sits at the intersection of GMP compliance and basic operational hygiene, and gaps here tend to be visible the moment an auditor walks the production floor.
This post is part of a series working through ISO 22716 section by section. The series summary with links to every section is available at the end.
Principle. Waste should be disposed of in a timely and sanitary manner — a short statement that sets the bar for everything else in the section.
Types of waste. Using findings from production and the quality control laboratory, the company needs to define the different types of waste that could affect product quality. Not all waste carries the same risk, and the standard expects that distinction to be made deliberately rather than treating all waste identically.
Flow. The flow of waste through the facility should not impact production or laboratory operations. This is a practical, physical requirement — waste routes and production routes need to be planned so they do not cross in ways that create contamination risk.
Containers. Waste containers need proper identification as to their contents and other relevant information, as appropriate to the type of waste involved.
Disposal. Disposal needs to happen in an appropriate way with an adequate level of control — which in practice usually means using licensed waste contractors where legally required and keeping records of what was removed and when.
The most common gap is waste flow crossing production flow in ways that were never deliberately planned. In facilities that have grown organically over time, waste collection routes often end up sharing corridors or doorways with raw material or finished product movement simply because that is how the building happened to develop — not because anyone designed it that way.
The second common gap is a lack of distinction between waste types. Treating all waste as equivalent — general rubbish and contaminated production waste handled identically — misses the standard’s explicit expectation that waste types affecting product quality get identified and handled with appropriate additional control.
Waste flow is closely linked to the premises and facility layout requirements covered earlier in this series — both are fundamentally about physical flow through the building. Where waste handling failures do create a contamination risk to product, that needs capturing through the same risk management framework used for other contamination hazards, rather than being treated as a separate, lesser concern.
This post is part of the Cornerstone ISO 22716 series. See the full series summary with links to all 16 sections.
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