What Are Good Clinical Laboratory Practices?

If you missed Part 1 of our GCLP series, read it now to learn what GCLP is, what GCLP is not, and the core elements that make up GCLP.

Good Clinical Laboratory Practice FAQs

With years of experience utilizing GCLP process flow to prepare pharmaceutical companies and laboratories for potential FDA audits, we’ve heard (and answered) many questions related to GCLP compliance.

Find several of the most frequently asked and intriguing GCLP questions below.

Have specific questions of your own?

Are these guidelines or standards?

GCLP are reference guidelines. There are no U.S. regulatory standards or guidelines for GCLP.

When the standards say documentation should be “readily available,” what does this mean?

Generally, the industry considers “readily available” to be within 48 hours.

What if a laboratory director deems these standards as unattainable?

If the laboratory director determines that any of the reference guidelines cannot be met, the laboratory director should explain why the guidelines are unattainable.

Are the appendices of the standards to be used exactly as they are for compliance with associated standards?

The appendices are provided to assist the reader in developing customized policies, procedures, or forms and are not intended to be used exactly as they are provided in the document.

Do study plans and analytical plans pertain to processing labs?

This is an option if the study protocol is considered inadequate. Often, study protocols may not address all tasks and processes that laboratory personnel must carry out when working with clinical trial specimens. In this case, a formal laboratory-specific supplement in the form of an analytical or study plan should be developed.

To whom should organizational charts be available? Do they need to be on display?

The charts should be available to individuals working in the laboratory or cleared to enter the laboratory and must be available at the request of an auditor.

Does documentation relevant to performance evaluations for staff in the laboratory need to be available to the monitors?

No, portions of personnel files such as performance evaluations or health records can be withheld if the management determines they are inappropriate for review.

Does staff identification have to be on display?

No, but the link/signature sheet should be available for review to associate codes, initials, signatures, or other markings used in identifying staff to a full printed name.

Does the manufacturer always perform certification of biosafety cabinets/laminar airflow hoods?

The DAIDS GCLP guidelines (a subdivision of the NIH) state that certification can be provided by a trained service technician, certified maintenance department, or manufacturing company. These certifications should be performed at least annually.

If humidity is a requirement, would all laboratories be required to add instrumentation to monitor and document temperature and humidity controls?

This is required if the manufacturer has set humidity ranges for any equipment, reagent, or assay.

How is “fireproof” storage defined?

Records should be stored in a manner in which they are protected from fire or duplicated such that if a fire occurs in a storage area, the data could be accessed via the back-up method. ​

Is there a guideline to define at what point sample transportation becomes sample shipping? When do IATA rules need to be followed, and when do DOT or other country rules need to be followed?

The DAIDS GCLP guidelines make no distinction between transport and shipping. The document does state that all federal and local regulations should be followed.

The standards state that laboratory personnel who ship specimens must renew regulation training every two years. To which regulation do the standards refer and what training needs to be completed?

This statement refers to IATA regulation. IATA training should be completed every two years. Retraining should occur if there are changes in the regulations during the interim.

Does sample storage require 24-hour monitoring, or is daily recording sufficient?

Both 24-hour monitoring and daily temperature recording are needed. Monitoring can be accomplished in several ways: computerized system, 24-hour staffing (security guard), min-max thermometers, etc.

To ensure that specimens are shipped within the temperature interval specified, does each shipment’s actual measured temperature need to be noted and documented?

Yes, the temperature should be noted and documented if a temperature requirement is present for the specimen. Min-max thermometers should be used during transport for total traceability throughout the shipping lifecycle with comprehensive documentation.

What if the manufacturer does not provide Material Safety Data Sheets (MSDS)?

Many online resources are free of charge, such as MSDS.com.

Who is responsible for ensuring that phlebotomy staff, clinic staff, and drivers have received safety training? Does the lab need to keep those records?

The laboratory leadership is responsible, along with the individuals themselves, for receiving training and keeping it updated. These records should be accessible. The onsite leadership determines the maintenance of these records.

Computer time-stamped audit trails must be used by the LIS. Is the LDMS compliant?

If the LDMS accommodates time-stamped audit trails, then it would be compliant with 21 CFR Part 11.

Are internal audits/self-assessment results available to external auditors (i.e., the FDA)?

Internal audit reports may be withheld from the FDA.

The laboratory must have a list of assay turnaround times readily available. Would this list include processing times?

Processing time is a large part of the pre-analytical process and should always be included in the assay turnaround time.

Could Your Laboratory Benefit from a Consistent and Standard Set of Guidelines?