High quality meets high standards

The EU Guidelines for Good Manufacturing Practice Annex 1 highlights the importance of selecting the right cleanroom garments, eyewear, socks, and shoes. With Lindström, you can get everything from the same provider.

Titled Manufacture of Sterile Medicinal Products, Annex 1 is a set of guidelines designed to ensure the safety and quality of sterile medicinal products. The updated version, released in 2022, places an even greater emphasis on contamination control and the importance of personnel in preventing contamination.

The importance of training

The Good Manufacturing Practice (EU GMP) Guideline Annex 1, classified the area in to four grades: A, B, C, and D. As an example, Grade A cleanrooms require a higher level of air quality than Grade B ones. Cleanroom garments and accessories must be appropriate for the process and GMP grade of the working area and should be visually checked for cleanliness and integrity before and after gowning. The garments and accessories should limit shedding due to operators’ movement and should be replaced if damage is identified.

The guideline emphasizes the importance of personnel training, gowning qualification, and assessment in disciplines relevant to the correct manufacture of sterile products. All personnel performing cleaning, maintenance, monitoring, and accessing cleanrooms should receive regular training. This training should include the basic elements of microbiology and hygiene, with a specific focus on cleanroom practices, contamination control, aseptic techniques, and the protection of sterile products. The level of training should be based on the criticality of the function and area in which the personnel are working.

Personnel accessing GMP grade A and B areas should be trained in aseptic gowning and aseptic behaviour. Compliance with aseptic gowning procedures should be confirmed by assessment and periodic reassessment at least annually. High standards of personal hygiene and cleanliness are essential to prevent excessive shedding and increased risk of introduction of microbial contamination. Personnel involved in the manufacturing of sterile products should be instructed to report any specific health conditions or ailments that may cause the shedding of abnormal numbers or types of contaminants such as respiratory droplets or flakes of skin and therefore preclude cleanroom access.

To summarise

The EU GMP Guideline Annex 1 plays a vital role in ensuring the safety and quality of sterile medicinal products. The updated version places a greater emphasis on contamination control and the role of personnel in preventing contamination. The guideline highlights the importance of selecting the right cleanroom garments, personnel training, and maintaining high standards of personal hygiene and cleanliness. Manufacturers must follow these guidelines to ensure the safety and quality of their products and protect the health of patients.

To support the pharmaceutical industry engaged in manufacturing the sterile products, Lindström provide high-quality cleanroom services with compliant garments and accessories that meet the required cleanliness standards, ensuring a hygienic workplace environment.