Good documentation practices

Good documentation practices ° Good laboratory practices... 

The quality control of larger libraries must take a systems approach [2], Building blocks must be checked rigorously [60], Chemistries must be extensively rehearsed with single compounds and small model libraries of a size where HPLC is likely to separate all of the members [61,62], Incorporation of a positive control is a good way to check on the successful synthesis of a library [63], Finally, steps should be taken to assure the completion of reactions in the actual library production and that good documented practices are followed in handling automated equipment. 

Quality Assurance — knowledge of Good Manufacturing Practice (GMP) and Good Documentation Practice... 

It may seem obvious to those of us who work in the industry on a day-to-day basis, but this requirement is not always obvious to vendor or supplier personnel. The omission of good document practices and the minimum document attribntes described above can cause great problems at any stage of the project. Reworking of docnments may canse regnlatory issues where the documentation is forced ont of the defined signing seqnence. 

Project documentation should adhere to good documentation practice. 

Establishing and following policies and procedures for good documentation practices, numerical rounding, significant figures, and directed audits to ensure the integrity of data contained in records or other documents prior to submission of applications to FDA). 

Good document practice requires that procedures be dated and reviewed on a predetermined frequency to ensme that the procedures still reflect the workplace. How often to review a procedme depends on the particular procedure and how static or fluid the company is. A three-year cycle is likely a good rule of thumb. Of comse, when there are changes in TSCA or in regulations, guidance, or case law, review the impacted procedures right away to ensure that as written they still ensme compliance, or to make whatever modifications are needed. 

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. 

Documentation that equipment complies with recognized and generally accepted good engineering practices... 

All stages of antibiotic manufacture from fermentation through to finished product are governed by the code of good manufacturing practice (GMP), of whieh quality eontrol is one aspect. GMP requires that there should be a eomprehensive system, so designed, documented, implemented and controlled, and so furnished with personnel, equipment and other resourees as to provide assuranee that products will consistently be of a quality appropriate to their intended use. ... 

PIC, 1992, Guide to Good Manufacturing Practice for Pharmaceutical Products (Document PH 5/92). 

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. 

In design it is typical that the same mistakes are done again since the use of available information is not organized. The use of case-based reasoning enhances the reuse of available experience, which reduces the possibility that the same errors are done more than once. In this work CBR was used for the evaluation of the inherent safety of process structure. The casebase was collected from design standards, accident documents and good engineering practice. 

Clinical Trials. In Phase I studies, good documentation and additional investigations should be standard practice. Serious reactions are pretty unusual in these studies, which will detect only very common ADRs, in particular those that are pharmacologically mediated (e.g., bradycardia with beta adrenergic receptor antagonists). 

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