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GMP and regulated cleaning

Cleaning as part of your quality system: your procedures, your products, your contact times, and a record you can show an inspector without rewriting it first.

Request a site walkCall 650-599-0202
A technician in a white coverall, hood and goggles mops a floor beside a red and blue bucket trolley and glove-box isolators.

What we look for

On the walk, with your quality lead.

  1. Procedures

    The cleaning SOPs that already exist, their revision, and the gaps we would be filling.

  2. Zones

    Production, support and corridors, and where each one's rules change.

  3. Chemistry and contact time

    Approved products, dilution, contact times, and how a deviation is written up.

  4. Equipment exteriors

    What we wipe, what we never touch, and what needs a work order.

  5. Training

    Site training, gowning qualification and who signs the training record.

  6. Records

    The log format, by room and lot, and where it is kept for the audit.

A person in a white coverall, hood, goggles and mask wipes the side of a large stainless vessel with a white cloth.
A person in a white coverall, hood and mask wipes the inside wall of a stainless isolator through its glove ports.

Inside the room

The procedure reaches every surface.

Agree the room, the method and the record before any work begins. Cleaning supports your quality system; it never replaces it.

  1. Planned with the facility and quality teams; filter faces stay yours.

  2. The approved operating conditions decide when we may be in the room.

  3. Accessible returns in the written scope, on their own frequency.

  4. Approved products, documented steps, contact times kept.

  5. Entry training complete and recorded before access.

What we write down

What goes into the scope.

  1. Procedures referenced

    Every SOP the scope depends on, by number and revision, so a change on your side triggers a change on ours.

  2. Deviations

    What counts as one, who is told the same shift, and how the correction is recorded.

  3. Audit support

    Training records, chemical lot records and cleaning logs in one package when the inspector asks.

Regulated rooms

  • A blue-gloved hand ticks a checkbox on a clipboard beside a cleanroom door window, a gowned worker inside.
  • Seen through a window, a person in a white coverall, hood, mask and goggles wipes a steel table beside a vial filling line.
  • A man in a white coverall and hood presses a gloved thumb against a round steel plate on a wall panel, looking closely at it.
  • A stainless steel floor drain with a slotted grate set in a gray resin floor, water droplets around it.
  • A woman in navy scrubs writes on a clipboard form beside a cleaning cart in a lab corridor.
More on gmp & compliance

Questions about GMP cleaning

Will you follow our SOPs or bring your own?

Yours. Where a procedure is missing, we draft one with your quality team and it becomes yours before we use it.

How are deviations handled?

The crew lead reports it the same shift, it is written up in the log, and the correction is recorded with who did it and when.

Can you support an inspection?

Yes. The records are kept in the format agreed in the scope and can be produced as one package.

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Call 650-599-0202