EU GMP Annex 1 - EU GMP Annex 1 and video review of your cleanrooms
ConductVision Aseptic Manufacturing can review video from your cleanroom cameras against the written procedures your site keeps under EU GMP Annex 1, and flag events for a trained reviewer on your team.
What Annex 1 covers
Annex 1 is the EU guideline for making sterile medicines, in EudraLex Volume 4. The current text took effect on 25 August 2023.
It asks each site to put a contamination control strategy in place across the facility. Your own procedures set what ConductVision checks against.
Your gowning assessments, environmental monitoring and aseptic process simulations stay as they are. ConductVision can check gowning and behavior during routine production.
What Annex 1 says about people and interventions
Only the minimum number of personnel required should be present in cleanrooms.
Cleanroom gowning and hand washing should follow a written procedure designed to minimize contamination of cleanroom clothing and/or the transfer of contaminants to the clean areas.
Gloves should be regularly disinfected during operations.
Movement of personnel should be slow, controlled and methodical to avoid excessive shedding of particles and organisms due to over-vigorous activity.
There should be an authorized list of allowed and qualified interventions, both inherent and corrective, that may occur during production (see paragraph 9.34).
Each line stoppage or intervention should be sufficiently documented in batch records with the associated time, duration of the event, and operators involved (ref to paragraph 9.34).
What you get
People in the room
More people in a room than allowed. See paragraph 7.2.
Gowning steps
The steps of your gowning procedure, checked in sequence. A missed or out-of-sequence step is flagged with a short clip. See paragraph 7.10.
Gloves
Gloves not disinfected before handling sterile supplies or before an intervention. See paragraph 7.16.
Movement
Fast movement near open product. See paragraph 7.18.
A record of each intervention
Each time a hand or arm enters the critical zone, with the time, the camera and a short clip, for your reviewer to check against your list of approved interventions. See paragraph 8.16.
Decisions kept with the clip
A trained reviewer on your team confirms each event, dismisses it with a reason or escalates it to QA. The audit trail keeps who decided, in what role, when and why.
Reports for quality investigations
A record of each event for your team to review in a deviation or investigation, and a monthly report by area and shift that one person reviews and a second person approves.
How a pilot works
Full recordings stay on your network. For each event it flags, ConductVision saves a record and a short clip at your site.
First look
We look at footage you choose to share with us and agree with your team on what to watch for.
Paid pilot
ConductVision connects to your camera system and runs for a set time.
Pilot results report
You get a report of the results on your own footage, checked against the criteria your team set.
Your decision
You decide whether to roll out, change the scope or stop.
One question to start with
Which of these checks would you start with?
More pages in this section
- Sterile drugs and biologicsFill-finish lines, RABS and isolators
- Cell and gene therapyOpen steps in biosafety cabinets
- Sterile compoundingHospital pharmacies and outsourcing facilities
- Medical devicesAssembly and packaging cleanrooms
- Food and beverageAseptic processing and packaging
- Electronics and semiconductorsFab, assembly and test cleanrooms
- Spacecraft and satellitesFlight hardware cleanrooms
- Cleanroom gowningGowning rooms and gowning procedures