3 minute read
COS-GMP
By Robert Low, Lead Management System Specialist
Section 8 of COS-GMP covers equipment, closely mirroring the structure of ISO 22716’s equivalent section while adding a distinct requirement around new equipment acceptance that is not explicitly named in the older standard.
This post is part of a series working through COS-GMP section by section. The series summary with links to every section is available at the end.
General and design. Equipment needs to be suitable for its intended purpose, cleanable, and sanitisable where necessary, with automated systems such as Clean-In-Place (CIP) specifically accounted for. Major equipment needs to be readily identifiable and defined. Operational equipment needs designing to prevent contamination, bulk product containers such as IBCs and barrels need protection from dust and moisture, and transfer hoses not in use need cleaning, sealing, and protection from contamination.
New equipment acceptance. This is the section’s most distinctive addition relative to ISO 22716. New equipment design and installation needs assessing for GMP suitability, with risks, procedures, cleaning, and maintenance practices created or updated as appropriate, and records maintained. The standard notes this is sometimes referred to as factory acceptance testing or equipment verification and validation — naming a practice that ISO 22716 implies but does not call out as its own discrete step.
Calibration. The site needs to identify and control in-line and off-line measuring equipment relevant to critical control measures and product quality, maintaining a register covering equipment location, identification code, recalibration due date, calibration date, and any adjustments made. Measuring equipment needs protecting from unauthorised adjustment and from damage, deterioration, or misuse. Accuracy needs specifying with permitted tolerances relevant to the parameter being controlled, with checks performed at a risk-based frequency by trained personnel. Where a calibration result falls outside acceptance criteria, the instrument needs identifying and removing from service, with the out-of-calibration condition investigated for impact on product quality.
Cleaning, sanitisation, and maintenance. A documented programme specific to each piece of equipment needs to define cleaning equipment, materials and dilutions from the Approved Materials Register, and contact times, with all cleaning validated for effectiveness. A signed, documented contract needs to define how subcontractors manage maintenance where applicable, with equipment maintained through a documented preventative maintenance programme and defective equipment identified, excluded from use, and isolated where possible.
Authorisation and access. Equipment and automated systems need restricting to authorised personnel, with passwords protected against unauthorised access where used for system control.
The most common gap is new equipment acceptance not being treated as a distinct, documented step. Equipment gets purchased, installed, and put into service, with cleaning and maintenance procedures created reactively once problems surface — rather than the GMP suitability assessment, procedure creation, and record-keeping happening proactively as part of the acceptance process itself, as this section requires.
The second common gap, shared with ISO 22716, is the calibration investigation step — confirming whether an out-of-tolerance instrument actually affected product quality during the period it was out of calibration, rather than simply recalibrating and moving on.
New equipment acceptance and calibration records connect to production control, since in-process checks rely on correctly functioning, properly calibrated equipment. Equipment registers and maintenance schedules also benefit from document control given the version history and contractual evidence this section expects.
This post is part of the Cornerstone COS-GMP series. See the full series summary with links to all 11 sections.
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