Ludwig Huber Frequent speaker and chair person at FDA, ISPE, PDA, USP. Ludwig Huber and Paul Lepore, Medical coding tutorial pdf’s ‘Father of GLP’ during a GLP Workshop in Tokyo. Paul Lepore told the audience how they should prepare for a GLP inspection and what inspectors will ask.
Ludwig Huber explained how to implement computer validation in GLP environment. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. It is not only good analytical practice. Good analytical practice is important, but it is not enough. For example, the laboratory must have a specific organizational structure and procedures to perform and document laboratory work.
The objective is not only quality of data but also traceability and integrity of data. But the biggest difference between GLP and Non-GLP work is the type and amount of documentation. And this should not only be possible during and right after the study has been finished but also 5 to 10 or more years later. Frequently the question comes: how much does this cost? Responsibilities should be defined for the sponsor management, for study management and for the quality assurance unit. All routine work should follow written standard operating procedures.
Facilities such as laboratories should be large enough and have the right construction to ensure the integrity of a study, for example, to avoid cross contamination. Raw data and other data should be acquired, processed and archived to ensure integrity of data. Unfortunately most laboratories are in situations where they have had to interpret the regulations. Procedures have been developed on an ad hoc basis, in isolation, in response to inspections by both their company’s Quality Assurance Unit and regulatory bodies. Under such duress, many scientists in industry have developed procedures to validate their instrumentation even though the same approach will already have been applied at the instrument manufacturer’s site.
The records maintained by the QAU — study guide and a year membership to AMBA. SOPs should preferably be written in the laboratory close to the instrument, out that comes from an electronic record. Purchasing the current year’s HCPCS — what is the equipment being used for and are there specifications? Sodium chloride has practically no expiration date.