RSSL puts the focus on cleaning
RSSL is stepping up its support for manufacturers in addressing cleaning validation, a discipline that is coming under increasing scrutiny from regulatory authorities
RSSL, one of the UK’s leading pharmaceutical CROs, is stepping up its support for manufacturers in addressing cleaning validation, a discipline that is coming under increasing scrutiny from regulatory authorities. RSSL is an established expert in the field and is co-ordinating its approach to cleaning validation with unique consultancy, analysis and training services that will ensure clients in pharmaceutical and bio-pharma production satisfy their regulatory requirements.
Validation is a GMP requirement, critical to pharmaceutical safety, and describes the process of obtaining the information that demonstrates whether or not a cleaning process is effective at removing active pharmaceutical ingredients, associated degradants and cleaning materials to a pre-determined and safe level. This validation is essential to avoid residue from a previously manufactured product compromising the quality and safety of the subsequent batch.
Despite its importance, cleaning validation is often poorly understood and not always implemented or documented in accordance with the regulatory requirements. RSSL will address these shortcomings with an expert team that can advise and support with inspections of a manufacturing site. ‘Walking the Plant’ can help get to the root of where residues are difficult to remove and therefore pose a considerable threat of batch to batch contamination.
RSSL’s dedicated analytical service will focus on key aspects such as maximum allowable carry-over (MACO), appropriate cleaning and sampling methodologies, and fit-for-purpose analytical methods for accurate residues determination.
In addition, RSSL provides consultancy and training courses to those involved with the design, execution and validation of cleaning processes. These services will provide a thorough grounding in process design and pitfalls to avoid, along with understanding of fundamental issues in the area.
RSSL’s pharmaceutical laboratories are equipped with a wide range of analytical techniques, allowing a tailored approach to cleaning validation.
'Cleaning validation is critical to safe pharmaceutical production and through our unique, combined service offering RSSL can support your cleaning validation strategy and build solid foundations to ensure compliance with the regulatory requirements,' says Marta Ahijado of RSSL.