GMP Cleaning Programs

Scope and frequency are set by what your SOP requires. Daily, weekly and periodic tasks are assigned to the intervals your documentation calls for, using the agents your facility specifies, in the sequence your procedures define.

Most programs include a monthly major cleaning: ceilings, walls and vertical surfaces, flat surfaces and floors, top to bottom, with the cleaning agent your SOP specifies. Ceilings are included whenever your requirements call for them. If your SOP changes, the program changes with it.

Your forms, digitized

We do not ask you to adopt our paperwork. We rebuild your cleaning forms digitally, room by room, so the record matches the document your quality system already approved.

This does not replace your paper. Your original forms, signed in ink, remain the record of truth and stay filed with your quality department exactly as your SOP requires. What we add is a way to find them.

Every cleaning creates a digital record carrying the classified room, the date, the GMP cleaning technician who performed the work, and their signature, captured on a signature pad using the same signature your quality system already has on file for that technician, so the two can be compared. Special events and additional cleanings outside the scheduled program are captured the same way.

Each record also holds a photograph of that day’s signed paper form. When an auditor asks what happened in Room 3 on a specific date, they can see the digitized original on screen while the physical form is being pulled from the file, instead of waiting through the search.

At the close of each month we send you a report containing every digitized form for that period. If your quality system runs on a different cycle, weekly, quarterly, or aligned to a review schedule, we send it on yours.

Why it matters in an audit

Auditors do not question whether cleaning happened. They question whether you can prove it, by whom, and when. A record with an attached image of the signed original answers that in seconds, for internal audits, client audits and FDA inspections alike.

Trained and certified before entry

Personnel qualification is not a side note in GMP. It is one of the most frequently cited findings in FDA inspections of drug manufacturers, and when a contractor works inside your classified space, their training becomes part of what you have to answer for.

Our GMP cleaning technicians are trained through a training program built into our own GMP-customized CRM. The curriculum is drawn directly from Title 21 CFR, covering the regulations themselves and the cleaning operations the technician will actually perform.

Training ends with a written examination of fifteen questions. A technician must answer at least eleven correctly to pass, with a maximum of three attempts, and every attempt is recorded. Only on passing is a certificate issued, and that certificate is filed in the system as documented proof that the individual entering your cleanroom was trained and assessed before entry.

The program and the certificate are issued in both English and Spanish. In practice that means a technician is trained and examined in the language they actually work in, rather than signing off on material they only partly followed.

That file is what we can produce when an auditor asks who cleaned your classified space and what qualified them to do it.