GMP Facility: Understanding Grade A, Grade B, Grade C and D | MECART (2024)

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GMP Facility: Understanding Grade A, Grade B, Grade C & D

Understanding the GMP requirements and their grades can be challenging at times, especially with different regulatory bodies in other countries. What are the differences between a Grade A, Grade B, Grade C, or Grade D cleanroom environment? This article will cover:

  • The differences between the grades
  • Their ISO Class equivalent at rest/in operation
  • Examples of applications for each GMP grade
  • Graphic charts (number of airborne particles, etc.)

Regulators such as the FDA in the United States or Health Canada ensure the quality of drug products. They put strict and precise regulations for drug manufacturers in the pharma industry.

The Good Manufacturing Practices (GMP) for manufacturing sterile medicinal products were created to ensure that the drugs are safe and contain the ingredients and amounts they claim. These criteria are intended to reduce the risk of microbiological, particle, and pyrogen contamination.

Also known as the current Good Manufacturing Practices (cGMP), the regulations cover production processes, quality control, packaging, personnel, and GMP facility. This article will focus on the latter, the good manufacturing practices for the cleanroom environment of your GMP Facility.

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GMP Cleanroom Requirements for Grade A, B, C, and D Facility

Cleanrooms do not entirely remove contamination; instead, they regulate it to a tolerable level. In cases where operations are likely to cause defects in the final product, a higher degree of cleanliness is required to avoid contamination.

Some operations, such as the manufacturing of non-sterile pharmaceuticals, do not automatically require a cleanroom, whereas sterile drugs necessarily do. The GMP clean air grades and classifications define the environment in which sterile drugs and biological products should be manufactured.

Under the GMP requirements, the manufacturing of sterile medicinal products can be distinguished into 4 grades: Grade A, B, C & D.

cGMP Cleanroom Grades Summary

Grade AGrade BGrade CGrade D
Sinks and drains prohibited in Grade A

High-risk operations (filling zone, stopper bowls, open ampoules, and vials, making aseptic connections)

Laminar airflow cabinet can obtain Grade A cleanliness in Grade B background

Equivalent to an ISO 5 cleanroom environment (at rest and in operation)

Sinks and drains are prohibited in Grade B

ISO 5 at rest, ISO 7 in operation

Particle monitoring system with alarm if limits are exceeded is required

Background zone for Grade A

Used for aseptic preparation and filling

Less critical operations

ISO 7 at rest, ISO 8 in operation

Monitoring depends on the quality risk management

Used for filling of productsfor terminal sterilization(at least in a Grade C)

Preparation of solutions to be filtered, including weighing

Less critical operations

ISO 8 at rest, not defined for in operation

Dirtiest area of GMP guidelines

Grade A

A cGMP Grade A environment is equivalent to an ISO 5, for both at rest and in operation. This means that whether employees are working or not, the cleanliness inside the cleanroom must maintain Grade A levels (ISO 5).

The required level of cleanliness for a Grade A area is obtained using a laminar flow cabinet or a laminar airflow hood (LAF). If the surrounding air is preserved and classed as Grade B, a laminar flow cabinet can attain a cleanliness classification of Grade A.

To achieve Grade A cleanliness level, the number of airborne particles smaller than 0.5 micrometers should not exceed 3,520 per cubic meter.

GradeMaximum permitted number of particles ≥ 0.5 μm/m3

At rest

Maximum permitted number of particles ≥ 0.5 μm/m3

In operation

ISO Class
At Rest/In Operation
Grade A3 5203 520ISO 5/ ISO 5

The Grade A area is dedicated to high-risk operations such as fill/finish (filling zone), stopper bowls, open ampoules, vials, and making aseptic connections.

Tasks and applications to do in a Grade A area:

  • Aseptic assembly of filling equipment
  • Aseptic compounding and mixing
  • Replenishment of sterile bulk products, containers, and closures
  • Removal and cooling of unprotected items from sterilizers
  • Staging and conveying of sterile primary packaging components
  • Loading of a lyophilizer

Grade B

The Grade B cleanroom, in operation, is equivalent to an ISO 7 environment, while at rest, it corresponds to an ISO 5 cleanroom. At rest, the Grade B cleanroom needs to meet a maximum of 3,520 particles (0.5 μm) per cubic meter. In operation, the number of permitted airborne particles increases to 352,000 (0.5 μm) for each cubic meter of air.

GradeMaximum permitted number of particles ≥ 0.5 μm/m3

At rest

Maximum permitted number of particles ≥ 0.5 μm/m3

In operation

ISO Class
At Rest/In Operation
Grade B3 520352 000ISO 5/ ISO 7

Sinks and drains are not permitted in Grade A and B areas. The Grade B room of your GMP facility must be equipped with a particle monitoring system including an alarm if limits are exceeded.

The Grade B cleanroom environment of your GMP facility is used for aseptic preparation and filling.

Other tasks and applications in a Grade B area:

  • Background support for the Grade A zone
  • Transport (while protected from the surrounding environment) of equipment, components, and ancillary items for introduction into the Grade A zone.

Some of our Grade B Cleanroom past projects:

Vaccine Manufacturing Facility (GMP)

Grade C

The Grade C cleanroom spaces are for performing less stringent steps of sterile product manufacturing. The airborne particle classification equivalent for Grade C (at rest and in operation) is ISO 7 and ISO 8, respectively.

At rest, the number of particles allowed for each cubic meter is 352,000, while the number is 3,520, 000 in operation.

GradeMaximum permitted number of particles ≥ 0.5 μm/m3

At rest

Maximum permitted number of particles ≥ 0.5 μm/m3

In operation

ISO Class
At Rest/In Operation
Grade C352 0003 520 000ISO 7/ ISO 8

The monitoring of the Grade C area should be implemented in line with quality risk management principles, thesystematic method for assessing, controlling, communicating, and reviewing risks to the quality of a medicinal product throughout its lifespan.

Examples of what activities should take place in a Grade C environment:

  • The filling of productsfor terminal sterilization(at least in a Grade C)
  • Preparation of components and most products should be done at least in a Grade D cleanroom. Still, some products with high or unusual risks of microbial contamination should be prepared in a Grade C area.
  • Preparation of solutions to be filtered, including weighing.

Some of our Grade C Cleanroom past projects:

cGMP Modular Cleanroom for Vaccine Plastic Components

GMP Cell Banking Cleanroom for Vaccine Production

Grade D

For Grade D, the airborne particle classification is the equivalent of an ISO 8 cleanroom at rest. While in operation, the particle classification is not predefined; it will depend on the nature of the processes taking place inside the zone. This is what we call a Clean Non-Classified (CNC) area.

GradeMaximum permitted number of particles ≥ 0.5 μm/m3

At rest

Maximum permitted number of particles ≥ 0.5 μm/m3

In operation

ISO Class
At Rest/In Operation
Grade D3 520 000Not defined (CNC)ISO 8/ – not defined

Like the Grade C cleanroom of a GMP facility, the Grade D area is used to perform less critical steps in manufacturing sterile drugs.

The Grade D environment can be a background zone, depending on how your cleanroom is designed. This is the least clean area of the GMP requirements for sterile products.

Here is a list of tasks that can be processed in a Grade D cleanroom:

  • Cleaning of equipment
  • Handling of components, equipment, and accessories after washing
  • Assembly of cleaned components, equipment, and accessories before sterilization
  • Assembly of closed and sterilized SUS using intrinsic aseptic connectors

Some of our Grade D Cleanroom past projects:

ISO 8 Packaging Room for a Biopharma CDMO (cGMP)

Cleanroom Grade A, B, C, and D Classification Chart

at rest (b)in operationFederal Standard 209E and the ISO classifications approximate equivalency
Grade0,5m m5m m0,5m m0,5m
A3 50003 5000100, ISO 5
B(a)3 5000350 0002 000100, ISO 5
C(a)350 0002 0003 500 00020000class 10000, ISO 7
D(a)3 500 00020 000not defined (c)not defined (c)class 100000, ISO 8

This chart is intended for reference only. Make sure to follow protocol specific to your cleanroom.


(a) To reach the B, C, and D air grades, the number of air changes should be related to the size of the room and the equipment and personnel present in the room. The air system should be provided with appropriate filters such as HEPA for grades A, B, and C.

(b) The guidance given for the maximum permitted number of particles in the “at rest” condition corresponds approximately to the US Federal Standard 209E and the ISO classifications as follows: grades A and B correspond with class 100, M 3.5, ISO 5; grade C with class 10000, M 5.5, ISO 7 and grade D with class 100000, M 6.5, ISO 8.

(c) The requirement and limit for this area will depend on the nature of the operations carried out.



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GMP Facility: Understanding Grade A, Grade B, Grade C and D | MECART (2024)


What is class A B C D in pharma? ›

Grade A is equivalent to class 100 or ISO 5. Grade B is also equivalent to class 100 or ISO 5. Grade C is equivalent to class 10,000 or ISO 7. Grade D is equivalent to class 100,000 or ISO 8.

What is a Grade D cleanroom? ›

Like the Grade C cleanroom of a GMP facility, the Grade D area is used to perform less critical steps in manufacturing sterile drugs. The Grade D environment can be a background zone, depending on how your cleanroom is designed. This is the least clean area of the GMP requirements for sterile products.

What is GMP grade? ›

​On the other hand, GMP grade or cGMP grade refers to products manufactured under Current Good Manufacturing Practices which require manufacturers ensure that their products are traceable, safe, pure and effective.

What is grade C in ISO? ›

Grade 8 (ISO 8/Grade C): A classified space that satisfies FDA requirements for: ISO 8 measured via airborne 0.5 μm particulate in the in-operation state. EMA and PIC/S requirements to meet ISO 8 measured via airborne 0.5 and 5.0 μm particulate in the in-operation state.

What is a Grade B cleanroom? ›

Grade A is the cleanest and is used for sterile operations. Grade B: This grade provides a background environment to enable aseptic preparation and filling for some grade A zone items. Grade C: Grade C cleanrooms are used to perform less critical activities needed for the non-critical manufacturing stages.

What is Grade A area in pharmaceutical industry? ›

A cleanroom or clean room is an environment, typically used in manufacturing or scientific research that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors.

What does grade C stand for? ›

Letter Grades. A+, A, A- indicates excellent performance. B+, B, B- indicates good performance. C+, C, C- indicates satisfactory performance.

What is D grade range? ›

D - this is still a passing grade, and it's between 59% and 69% F - this is a failing grade.

What is grade A air quality? ›

Air which is passed through a filter qualified as capable of producing grade A non-viable quality air, but where there is no requirement to continuously perform non-viable monitoring or meet grade A viable monitoring limits.

What are GMP qualifications? ›

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous.

What is a GMP facility? ›

A GMP Facility is a production facility or a clinical trial materials pilot plant for the manufacture of pharmaceutical products. It includes the manufacturing space, the storage warehouse for raw and finished product, and support lab areas.

Is C or C better grade? ›

The typical letter grades awarded for participation in a course are (from highest to lowest) A, B, C, D and F.

Is C grade better than B? ›

The state of New South Wales is a popular study destination in Australia.
Primary, Secondary, and Senior Secondary Grades (High Schools)
GradeGrade NamePercentage
AExcellent85% and above
BGood70% to 84%
CSatisfactory51% to 69%
3 more rows

What is grade C product? ›

Grade C: This may include items showing signs of use. Items may not be in original packaging or the packaging may be missing. Accessories may be missing and the items may have visible imperfections (in the case of White Goods, visible imperfections will include dents, scuffs and scrapes).

What is Type A and Type B Cleaning? ›

Mentioned the type of cleaning as: Type A: Product to Product change over. Type B: Batch to Batch change over. Type C: Shift end cleaning.

What does quality B mean? ›

B Quality means the shell must be unbroken, may be abnormal, and may have slightly stained areas. Moderately stained areas are permitted if they do not cover more than one-thirty- seconded (0.8mm) of the shell surface if localized, or one-sixteenth (4.8mm) of the shell surface if scattered.

What is the highest grade of clean room? ›

ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it's classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.

What does it mean to be pharmaceutical-grade? ›

A drug, biologic, or reagent that is approved by the Food and Drug Administration (FDA) for use in humans or animals or for which a chemical purity standard has been established by the United States Pharmacopeia-National Formulary (USP-NF), or British Pharmacopeia (BP).

What makes a product pharmaceutical-grade? ›

Pharmaceutical-grade substance: means any active or inactive drug, biologic, reagent, etc., manufactured under Good Manufacturing Practices (GMP) which is approved, conditionally approved, or indexed by the Food and Drug Administration (FDA) or for which a chemical purity standard has been written or established by a ...

What is 100 grade A class area? ›

Class 100 area is defined as area where there should not be more than 100 particles of 0.5 micron per cubic foot of air. Class 1000 defined same where there should not be more than 1000 particles and so on respectively. Clean room has HEPA filters to clean the incoming area.

What is a B and C grades? ›

GRADE POINT VALUES GRADE POINT VALUES A = 100 - 90 4 A = 100 - 93 4.00 B = 89 - 80 3 A- = 92 - 90 3.66 C = 79 -70 2 B+ = 89 -

What is a D in percentage? ›

Letter GradePercentage RangeMid-Range
D+55% to 59%57.5%
D50% to 54%52.5%
E40% to 49%45%
F0% to 39%20%
6 more rows

What is B in numerical grade? ›

Each grade has a numerical value which. A = 4. B = 3. C = 2.

Is a grade D an A level pass? ›

A pass in an AS subject is indicated by one of five grades A(a), B(b), C(c), D(d), E(e), of which grade A(a) is the highest and grade E (e) is the lowest. grade N indicates that the student's performance fell short of the standard required for grade E (e) by a narrow margin.

What grade is a B? ›

A B- letter grade is equivalent to a 2.7 GPA, or Grade Point Average, on a 4.0 GPA scale, and a percentage grade of 80–82.
List of Common GPA Conversions.
Letter GradePercent Grade4.0 GPA Scale
8 more rows

Is D considered failing? ›

A letter grade of a D is technically considered passing because it not a failure. A D is any percentage between 60-69%, whereas a failure occurs below 60%. Even though a D is a passing grade, it's barely passing.

What are the 6 levels of air quality? ›

How does the AQI work?
Daily AQI ColorLevels of ConcernValues of Index
GreenGood0 to 50
YellowModerate51 to 100
OrangeUnhealthy for Sensitive Groups101 to 150
RedUnhealthy151 to 200
2 more rows

What are the 5 air quality index categories? ›

There are six AQI categories, namely Good, Satisfactory, Moderately polluted, Poor, Very Poor, and Severe.

What is the best air quality score? ›

The six levels of health concern and what they mean are:
  • "Good" AQI is 0 - 50. ...
  • "Moderate" AQI is 51 - 100. ...
  • "Unhealthy for Sensitive Groups" AQI is 101 - 150. ...
  • "Unhealthy" AQI is 151 - 200. ...
  • "Very Unhealthy" AQI is 201 - 300. ...
  • "Hazardous" AQI greater than 300.
Oct 13, 2022

Why C is small in CGMP? ›

Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.

How many types of GMP are there? ›

Assuring quality of a manufactured product requires certain procedures and standards. In many industries, these procedures and standards are often referred to as Good Manufacturing Practices, or GMPs.

What are the 3 importance of GMP? ›

Good Manufacturing Practices are a critical system that all manufacturing facilities should implement. They help ensure the proper design, monitoring, and control of the manufacturing processes and facilities. Companies that adhere to these standards help to assure the identity, strength, and quality of their products.

What are the two components of GMP? ›

GMPs have two main components: written programs and implementation. Both are essential for the success of your food safety system. Good Manufacturing Practices* (GMPs) are the basic operational and environmental conditions required to produce safe foods.

What are GMP examples? ›

Good Examples of GMPs
  • Incoming raw materials are inspected for quality.
  • An allergen control program is in place.
  • Product recalls are well-documented and controlled.
  • Labeling and packaging meet industry standards.
  • Products are traceable throughout the manufacturing process.
Aug 17, 2022

What are the 10 principles of GMP? ›

10 Principle of Good Manufacturing Practises

These regulations address a variety of areas, including cleanliness, personnel qualifications and record-keeping, all in an attempt to ensure safety in the manufacture and care of FDA-regulated products by minimizing the chance of contamination or human error.

What are the 5 stages of manufacturing? ›

Each stage has purpose and goals, and it is important that in each phase the goals are met before proceeding to the next. The 5 stages are development, pre-production, production, post-production, and distribution.

What are the 4 types of manufacturing industry? ›

The four main types of manufacturing are casting and molding, machining, joining, and shearing and forming.

What are the different classes of pharmaceutical analysis? ›

Based upon the determination type, there are mainly two types of analytical methods. They are as follows: Qualitative analysis: This method is used for the identification of the chemical compounds. Quantitative analysis: This method is used for the determination of the amount of the sample. ...

Is pharmaceutical grade the same as food grade? ›

Pharmaceutical grade – These are raw materials that meet the pharmaceutical standards for manufacturing. They are highly pure and contain no binders, fillers, or other unknown substances. Food grade – These materials meet the standards for safe human ingestion and can safely come into direct contact with food products.

What are pharmaceutical grade products? ›

A pharmaceutical grade product is a substance that the FDA has approved for human or animal consumption that meets stringent purity standards. Chemicals and compounds that meet these standards allow manufacturers to create drugs with consistent quality, effectiveness, and purity.

What is pharmaceutical aid give their classification? ›

Pharmaceutical aids are the drugs and substances which have no or little pharmacological effect but they are essentially used in the preparation of pharmaceutical dosage form (like tablet, injection, emulsion, ointments etc).

What are the 3 main classes of drugs? ›

The three categories of drugs are Class A, Class B and Class C: heroin, cocaine, ecstasy and LSD are Class A drugs. speed, cannabis, ketamine, mephedrone and some amphetamines are Class B drugs. anabolic steroids, GHB and some tranquilisers are Class C drugs.

What are the types of drug classes? ›

DREs classify drugs in one of seven categories: central nervous system (CNS) depressants, CNS stimulants, hallucinogens, dissociative anesthetics, narcotic analgesics, inhalants, and cannabis.

What are the five major drug classes? ›

Here are the five main categories and some information about each:
  • Central nervous system depressants.
  • Central nervous system stimulants.
  • Opiates and Opiodes.
  • Hallucinogens.
  • Marijuana.

Is there Grade B food? ›

U.S. Grade B Grade B vegetables are of excellent quality but not quite as well selected for color and tenderness as Grade A. They are usually slightly more mature and therefore have a slightly different taste than the more succulent vegetables in Grade A.

What is Grade A in food? ›

In the United States, there are two grades of milk, with Grade A primarily used for direct sales and consumption in stores, and Grade B used for indirect consumption, such as in cheese making or other processing.

What are the different grades of chemicals? ›

Below is a list of chemical grades in order of purity, from highest to lowest.
  • ACS. Highest quality; often equals or exceeds the latest purity standards set by the American Chemical Society (ACS). ...
  • Reagent. Purity is generally equal to ACS grade. ...
  • USP. ...
  • NF. ...
  • Lab. ...
  • Pure. ...
  • Technical. ...
  • Lab Safety Equipment from Carolina.

What is the difference between medical grade and pharmaceutical grade? ›

What's the Difference Between Medical-Grade and OTC (Over-the-counter) Skincare Products? The primary difference between OTC and medical or pharmaceutical-grade skincare products is that one can only be prescribed by a medical professional.

What does 100% pharmaceutical grade mean? ›

The Pharmacopoeia deals with the purity and quality of an ingredient and sets the standards high. If an ingredient is to be labelled “Pharmaceutical Grade” the product must be in excess of 99% purity with no binders, fillers, excipients, dyes, or unknown substances while maintaining strict quality control.

How many categories are there in pharmacy? ›

The field of pharmacy can generally be divided into three primary disciplines: Pharmaceutics. Pharmaco*kinetics. Medicinal Chemistry and Pharmacognosy.

How many divisions are there in pharma? ›

The Indian pharmaceutical industry has 5 important segments; contract research and manufacturing services (CRAMS), active pharmaceutical ingredients (APIs), formulations, biologics and biosimilars, and vaccines. Various types of companies are within these segments.

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