Validating cleaning procedures in biopharmaceutical manufacturing facilities
For full version of manuals and procedures please read more by clicking the "Subscribe" button on the left.This procedure describes general validation concepts and practices, the way processes and systems must be qualified/validated and the confirmatory documentation required.
The Food and Drug Administration's (FDA) guidance for determining residue limits is that they must be logical (based on understanding of the process), practical, achievable, and verifiable.This process can be expensive and challenging, however, in facilities where 30-40 different oral solid-dose products may be manufactured each year.Generally, best cleaning procedures are defined based on monitoring final drug content, p H, and the conductivity of water samples for each product until they are within acceptable ranges.This article examines a new way of doing this, using experimental design methods to define different procedures for intermediate bulk container (IBC) cleaning.The authors have evaluated this new approach, in which a highly soluble, low-dose product and a relatively insoluble high-dose product constituted experimental input variables.Regulatory scrutiny is more rigorous in a multiproduct facility compared to a single product establishment.
Companies are usually cited either for not having a sound cleaning validation or not meeting the protocol acceptance criteria.
Apart from being a core aspect of current Good Manufacturing Practice (c GMP) and Good Validation Cleaning Practice (GVCP) in the pharmaceutical industry, pharmaceutical cleaning validation procedures are a necessary regulatory condition that must be met by pharmaceutical companies in getting safe and effectual drug formulations to patients.
The cleanliness of any pharmaceutical equipment/plant is established by using what is known as the Residual Acceptance Limits (RAL).
This article examines using experimental design methods to define different procedures for intermediate bulk container cleaning.
The authors have evaluated this new approach, in which a highly soluble, low-dose product and a relatively insoluble high-dose product constituted experimental input variables. 2, 2015 Defining cleaning procedures is crucial to ensuring the elimination of product residues from non-dedicated process equipment.
FDA's initiative in pharmaceutical c GMPs for the 21st Century is a science and risk-based approach to product quality regulation.