GMP (Good Manufacturing Practice) standards for cleanrooms are critical in ensuring the quality and safety of products in industries such as pharmaceuticals, biotechnology, and food processing. Here are the main standards and requirements:

: Cleanrooms are classified based on the number of particles per cubic meter at a specified particle size. The ISO 14644-1 standard defines the cleanliness levels by classifying cleanrooms from ISO Class 1 (the cleanest) to ISO Class 9. GMP cleanrooms are commonly classified as Grade A, B, C, or D in the EU, which correlate to specific ISO classes.

: Cleanrooms must maintain strict control over environmental factors, including temperature, humidity, and air pressure. HVAC systems with HEPA or ULPA filters are used to achieve the required air cleanliness levels.

: The flow of personnel and materials must be controlled to minimize contamination. This includes the use of airlocks, gowning rooms, and pass-through chambers.

: Regular cleaning and disinfection protocols must be established and followed to maintain cleanliness levels. Cleaning agents and disinfectants should be appropriate for the cleanroom environment and not introduce contaminants.

: Continuous monitoring of environmental parameters, such as airborne particles, microbial contamination, temperature, and humidity, is essential. This ensures that the cleanroom maintains the required conditions at all times.

: Detailed documentation of all procedures, cleaning schedules, maintenance activities, and environmental monitoring results is crucial. This ensures traceability and accountability.

: Personnel working in GMP cleanrooms must undergo thorough training on contamination control, proper gowning procedures, and cleanroom protocols.

: Cleanrooms and their associated equipment must undergo rigorous validation and qualification to ensure they meet GMP standards. This includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Adherence to these standards helps ensure that products manufactured in GMP cleanrooms meet the necessary quality and safety requirements.