Good Laboratory Practices documentation

Most definitions of raw data concentrate on paper and/or electronic records. A good, concise definition is found in the FIFRA Good Laboratory Practice document (1) " Raw data means... 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

At this stage in planning, the essential study design information listed below should be determined and a written study plan (i.e., protocol) including these key study details prepared. A formal, pre-approved study plan is required for field soil dissipation studies conducted under Good Laboratory Practice (GLP). A written study plan for non-GLP studies is highly recommended since the document serves as valuable guidance for study personnel. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

You have your methodology both verified and validated as required for measurements needing a high level of confidence. But, you must also assure that your analyst Is experienced In performing the type of analysis you need, that you have standards for the analytes available, and that you have a written quality assurance plan that documents good laboratory practice. 

Like any document, the toxicology report must be fit-for-purpose. Its content and format must be tailored to meet the requirements of the reader (not just the convenience of the author). The main difficulties arise because the report has to serve scientific, administrative, and regulatory functions, which often have contradictory constraints. Furthermore, the document must comply with Good Laboratory Practice (GLP) regulations, which are inconsistent between regions or even within the same region for different types of test substance (see Note 1). Once the report has been issued (in draft or final form), it will be consulted by many different experts, each with their own agenda ... 

Good Laboratory Practice 58.105(a) requires that all test articles be appropriately characterized. Compliance requires documentation that characterization has been done. The tests conducted to provide this documentation, however, are not GLP-regulated, although such tests wiU in many instances be subject to CGMP standards (e.g., when the test article will also be used in human clinical studies). 

Good Laboratory Practice deviations that were of a continuing nature throughout the course of a study will require a conforming amendments statement of the reason for the noncompliance. One-time deviations from GLP requirements should be documented in study records and should be described in the final report but will not require a conforming amendments statement of the reason for the noncomphance. 

In a modem laboratory the general guidehnes encompassed in good laboratory practices require careful interpretation when apphed to a laboratory that relies heavily on automated documentation, data files, and electronic signatures 21 CFR part 11 provides that interpretation. 

Good documentation practices ° Good laboratory practices... 

Good Laboratory Practice, GLP Consensus document, The Role and Responsibilities of the Study Director in GLP studies, 1999. 

Be fully documented (e.g., conducted to Good Laboratory Practice (GLP))... 

All these studies should be performed in compliance with good laboratory practice (GLP) where feasible. The screening battery is frequently performed with full GLR More complex or specialized studies should be well-designed, properly controlled, and carefully documented when not in compliance. When safety pharmacology endpoints are incorporated into toxicology studies, not an uncommon situation, they should be conducted under GLP. 

---