Revised Schedule M sets the gowning requirement by cleanroom grade, not by job title. That means 4 separate grade regimes in one plant, each with its own garment set, its own qualification and its own re-qualification interval. Most gowning SOPs are written once and applied everywhere, which is where the inspector starts.
Surveyed, installed and commissioned by our own engineers.
Three deployment models, and nobody is subcontracted.
They trust VB
01 Installed and running
Three figures, and nothing else. There is no gowning-specific number on this page because none has been measured in a way that would survive a question.
100+
Plants and sites running VijAI
18,200+
Unsafe acts recorded
0
New cameras required to start
Source · VijAI deployment register, September 2026. Figures are counts of recorded events and installed sites, not outcomes.
02 The requirement
Read the gowning clauses on their own and they look like a list of garments. Read them beside the grade definitions and they turn into four different regimes that happen to share a building.
The instrument does not ask what somebody does for a living. It asks which classified area they are about to walk into, and it sets the garment, the qualification and the interval from that. A maintenance engineer entering a Grade B room is held to the Grade B regime for the time they are in it. So is a visiting auditor. So is the plant head.
That single sentence is where most gowning files come apart, because the file was built around people and the requirement is built around doors.
Written out, the requirement is eight fields, and you need one sheet of them per grade.
Listed by room number and airlock number. Department names change and rooms do not, and a sheet keyed to a department stops matching the building within a year.
Every item, including what covers hair and beard, and whether the set is sterile. This is the field that differs most between grades and the one most often written once for the whole suite.
The order, and the named change room or airlock. A sequence with no stated location cannot be observed, and an unobservable sequence cannot be qualified against.
Written as categories and never as a list of names: operators, quality, maintenance, contractor engineers, visitors, managers. A file built from the payroll will always miss the shutdown crew.
How a person is qualified for this grade and what the qualification actually measures. "Gowning verified" is not a method, and where no method is stated the weakest reading is the one assumed.
The field that decides the file. Every other field stays true once it is right. This one expires person by person while the sheet continues to look complete.
What shows that a person passed through the airlock, who checks it, and how often. The requirement names the door; this field is what makes the door produce evidence.
Quality approval with a date, and the sheet's own next review date held in the document system rather than in somebody's diary.
Two of those eight, the garment set and the interval, change with the grade. Here is how.
Read the lightest row first. Grade D cleanroom gowning requirements are the least demanding of the four and the most often treated as if they covered the whole suite, because they are the ones everybody in the building has met.
| Grade | Where it applies | What the garment set has to do | Who sets the interval |
|---|---|---|---|
| D | Support areas and the outer change rooms feeding a classified suite. | Protective clothing with hair, and where relevant beard, covered. Footwear or overshoes for the area. The purpose is to stop what the person brought in with them from travelling further. | You do. The instrument states the duty; the interval is a plant decision recorded in the SOP. |
| C | Preparation and support rooms adjacent to aseptic processing, and the airlocks into them. | Hair and beard covered. A single or two-piece suit gathered at the wrists with a high neck. Material chosen so it does not shed fibres or particles. | You do, on the same reasoning as Grade D, and this is the grade most often left without a stated interval at all. |
| B | The background environment for aseptic processing, and every airlock serving it. | Headgear enclosing hair and beard. A face mask. Sterile non-shedding one-piece or two-piece suit gathered at wrists and high at the neck. Sterile footwear with trousers tucked in. Sterile gloves with sleeves tucked into them. | The instrument does. Qualification and periodic re-assessment are explicit for the people who work here. |
| A | The critical zone itself, inside the Grade B background. | As Grade B, worn and behaved in so that the critical zone is never crossed over. The garment stops being the whole answer here; the movement is part of it. | The instrument does, and the assessment covers aseptic behaviour and not only the gowning sequence. |
The table states what each grade's garment set has to achieve rather than quoting clause text. The clause numbering is deliberately not reproduced here. A qualified person verifies the pinpoint citations before this page goes live, and the approval sheet lists exactly which ones.
One grade, filled in, from a sterile injectables facility. No sector detail beyond that, no state named, and never a plant of ours.
GOWNING REQUIREMENT SHEET one sheet per grade
01 GRADE ....................................
Rooms and airlocks covered ....................................
(list by room number, never by department name)
02 GARMENT SET ....................................
Hair and beard covered by ....................................
Sterile? YES / NO
03 DONNING SEQUENCE ..... steps, order attached
Performed in ....................................
SOP and revision in force ....................................
04 THE DUTY COVERS ....................................
(categories, not names: operators, QA, maintenance,
contractors, visitors, managers)
05 QUALIFICATION METHOD ....................................
What it measures ....................................
Recorded where ....................................
06 RE-QUALIFICATION INTERVAL ..... months
Who holds the next-due date ....................................
Names falling due this quarter ..................................
07 HOW AN ENTRY IS RECORDED ....................................
Checked by ....................................
How often ....................................
08 QUALITY APPROVAL ................ DATE ..............
Sheet next reviewed ....................................
Take it into your own document system and give it your own numbering. The order matters more than the format: the duty and the interval sit after the garment set, because that is the order the questions arrive in.
Current against · the Drugs and Cosmetics Rules, 1945, revised Schedule M Part I, personnel and hygiene · the aseptic manufacturing guidance that governs gowning qualification and periodic re-assessment · ISO 14644-1 cleanroom classification. Re-verified October 2026.
Because it is the only field on the sheet that has to still be true tomorrow.
A garment list is either right or wrong and it stays settled for years. A donning sequence is printed at the station. A qualification record is a signed event with a date on it, and signing it felt like completing something. The re-qualification interval is the field that quietly expires, person by person, while the file continues to look complete.
The second list is not hard to hold. It is hard to hold accurately, because it changes every time a person is added, a contractor arrives for a shutdown, or somebody moves between grades. A file that is accurate on the day it is printed and wrong three weeks later is the normal condition, not a failure of care.
Cleanroom gowning verification comes down to three honest answers, and it is worth being blunt about which is which.
Somebody watched. This is the strongest evidence and the least sustainable. It holds for a qualification session and it does not hold at two in the morning on a Sunday.
The person signed. This is what most plants hold. It records an intention and a presence. It does not record what happened at the door, and an inspector knows the difference.
The door produced a record. Every passage through the airlock generates one entry, whether or not anyone was watching, and the entry says whether the sequence completed. This is where a camera already pointed at the final door earns its place, and it is the only one of the three that covers a period rather than a sample.
None of these three makes a person compliant. They evidence whether the control ran. That distinction is the whole argument of this page and it is also the line we will not blur in a sales conversation.
Every one of those five is a condition rather than a person. That is not diplomacy, it is accuracy: all five survive a change of staff, and four of them are created by a document system rather than by anybody at the airlock.
It watches the final door into the classified area, from the clean side, on a camera that is usually already there. For every passage it writes one record: the time, the direction, and whether the gowning sequence completed. That gives you the second list in the question above, for a period, without anybody standing at the airlock.
It makes no claim about a person's qualification. Qualification is an assessed judgement made by your quality function, and this page will not pretend a camera performs it. It also makes no claim about sterility or about microbial state, which are measured by methods a camera has no access to.
What it does is narrower and more useful than either: it turns the airlock from a place where a requirement is asserted into a place where a requirement is recorded.
Deployment is on-premise, hybrid or cloud. Most Indian pharma sites choose on-premise, and the model is settled during the survey rather than quoted in advance. The survey tells you which of your existing cameras already cover the final doors, and most sites find they are covered.
L0 · THE MODULE
What PPE and gowning detection does across a plant, and the grades of work it covers.
The module →L3 · THE RESPONSE
The format a plant files after an observation, field by field, with a worked example and the five things that get it returned.
The format →NEXT · ONE AIRLOCK
Which of your existing cameras already cover the doors into your classified areas, and what a record from one of them looks like.
Talk to us →Sources · the Drugs and Cosmetics Rules, 1945, revised Schedule M, Part I, the personnel and hygiene provisions · the aseptic manufacturing guidance governing gowning qualification and periodic re-assessment · ISO 14644-1, cleanroom classification by airborne particle concentration. Named in text and not linked, so nothing on this page sends a reader away from it.
03 How it runs
The first question IT asks is where the video goes. All three answers are here, and detection by default with identification optional applies to every one of them.
| Model | Where the video is processed | Where it fits |
|---|---|---|
| On-premise edge | Entirely inside the plant. Nothing leaves your network. | Licensed areas, sites with a data-residency rule, and plants with no dependable outbound link. |
| HybridRecommended | Detection at the edge, dashboards and reporting hosted. Footage stays on site. Only events leave. | Most plants. Video stays inside the boundary and head office still gets one view across every site. |
| Cloud | Processing and storage hosted. | Single sites, short pilots, and estates already running their VMS this way. |
The model is chosen in the survey, against your network and your data rules. It is not a price tier.
04 Who installs it
Survey, engineering, installation, commissioning, calibration, training and support are all done by VB people. When a camera angle is wrong on a Sunday night, the person who fixes it is the person who chose it.
05 The five we are asked
Revised Schedule M restates India's good manufacturing practice requirement along the lines of WHO GMP. For gowning it means the garment set, the qualification and the re-qualification follow the grade of the area a person enters, and the duty covers everyone who enters it.
A gowning SOP states the sequence, the garment set and the order of donning for one grade, names where the sequence is performed, and states how an entry is recorded. One SOP covering every grade is the most common finding against a gowning file.
ISO 14644-1 classifies the room by particle count and does not prescribe a garment. The garment follows the GMP grade mapped onto that class, which for an ISO Class 7 room in operation is Grade B or Grade C depending on the activity.
The revision was notified in December 2023 under the Drugs Amendment Rules and the compliance window for smaller manufacturers was extended more than once afterwards. Check the current notification before relying on a date, because the deadline has moved.
The notification is dated December 2023. The requirement itself was not new for large manufacturers, who were already building to WHO GMP, and the change landed hardest on plants that had been running to the previous text.
06 The next step
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