Campaign production

The decision to use a facility or filling line for campaign production should be justified in a documented manner and based on a systematic risk approach considering the control requirements for each product (or strain) and the risk of cross-contamination. Next product. Campaign change procedures should be validated, including the sensitive techniques used to determine residues, and accurate cleaning acceptance criteria should be defined based on the toxicology of product residues from the last campaign, as applicable. Equipment allocated to continuous production or to campaigns of successive batches of the same intermediate product should be cleaned at appropriate validated intervals to prevent the build-up and carryover of contaminants (such as product degradants or objectionable levels of microorganisms).

For downstream operations of some products (for example, pertussis or diphtheria vaccine) campaign production may be acceptable if well justified. The need for dedicated facilities for finishing (formulation and filling) or campaign use of the same facility will depend on the specific characteristics of the biological product, the characteristics of other products (including any non-biological product). Filling technology used (eg single-use closure systems) and local NRA regulations. Labeling and packaging operations can be performed in a multi-product facility.

Campaign changes include intensive decontamination/sterilization (if necessary) and cleaning of equipment and production areas. Sterilization/disinfection (if required) and cleaning should include all equipment and accessories used during production, as well as the facility itself. The following recommendations should be considered:
■ waste should be removed from the production area or sent to a bio-waste system in a safe manner;
■ Materials should be transferred by a valid method;
■ The quality unit must confirm area clearance by inspection and review campaign change data (including observation results) before releasing the area for the next product.

When required, corresponding liquids can be replenished for the product at the same facility in line with the campaign manufacturing strategy defined for the finished product.

When campaign-based production is considered, the facility layout and design of premises and equipment allow for effective cleaning and sterilization/sterilization (if necessary) based on QRM principles and valid procedures after the production campaign. Additionally, the potential need for fumigation may require consideration at the design stage of the facility layout.

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