INFECTION CONTROL Ing. Alberto L. Gómez Copello – Gómez Copello y Asociados
Contamination control: can cGMP help?
This article looks at how the application of cGMP methodology in the hospital environment can improve infection control.
In the last century, the pharmaceutical industry has introduced several new quality standards. One was Quality Assurance, or QA: Quality was not a random result, but a part to be added to the product itself. Standard operation procedures; double
checking; and validation were three concepts that eventually evolved in the 70s into the Good Manufacturing Practices. cGMP refers to the Current Good
Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs set out systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations includes a need to establish strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. These regulations evolved into a way of
thinking about quality and how to build it into the product. A common phrase was ‘This is (or is not) GMP’, indicating that a particular object or procedure fell within (or outside) the GMP.
Applying cGMP methodology The greatest achievement of these new regulations was that they covered facilities design and maintenance, gowning, disinfection, preparation, operation and
Stepping in the same place where somebody has been walking with dirty shoes makes your shoes dirty.
IFHE DIGEST 2015
paperwork as part of the manufacturing process. This methodology can also be applied to the healthcare procedures. Standard Operation Practices (SOPs) has to be written and supervision has to ensure that they are followed in every case. For example, operating theatres are to be
classified according to ISO 14644-1 cleanliness levels; airflow patterns should be established in order to determine if the critical procedures are being done in an adequate environment. Cleanliness procedures are to be also
specified, as well as training of the cleaning personnel, approval procedures for the quality of the cleaning and sanitization products, as well as the expiration date of each container. Periodical testing for surface particle and microbiological cleanliness shall be performed in a standardised way. All surgical clothing should be
manufactured in suitable fabrics that are neither fibre or particle- shedding – designed to avoid particles from the surgical team being scattered into the room’s atmosphere. Cleaning and sterilisation of this clothing should also be specified and verified. Gowning procedure should also be standardized and, if
the clothing is to be used in contact with an infectious patient, clothing disposal and sanitisation also has to be specified. Preparation and distribution of specialised drugs, such as oncological products, enteral and parenteral nutrition solutions, as well as prescription drugs, also need to be planned and verified. Taking, for example, a parenteral nutrition
solution. The physician in charge needs to order the nutrients required for each patient, and the order is delivered to the pharmacist in charge of the hospital pharmacy. They analyse whether the order can be prepared, and develop the procedure to prepare the solutions. A protocol shall be issued, indicating the drugs and materials needed, as well as the preparation technique and
Alberto L. Gómez Copello Alberto L. Gómez Copello is a chemical engineer who
graduated from the University of Buenos Aires in 1975. He is a former department head of Industrial Engineering and Projects at Eli Lilly Argentina; a technical manager at Mino Covo and, since 1998, owner of Gómez Copello y Asociados, a firm that specialises in cleanroom and containment area projects.
He has addressed several lectures on cleanroom design, pharmaceutical projects and biosafety areas in Argentina, Uruguay and Paraguay.
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