Documentation practices

A signed statement by management without its approval to the quality system documented policies and procedures will indicate that it is not committed to honoring the policies and procedures. Managers need to approve the documents within the quality system that prescribe activities for which they themselves are responsible. This serves to demonstrate that they agree with the manner in which the policy has been interpreted and are prepared to provide the resources needed to implement the documented practices. 

The standard only refers to procedures as the category of quality system documentation. If we use the term documented practices we have a wider choice as to the types of documents we put into the quality system. Many documents are not procedures. They do not tell us how to proceed or specify a way to perform an activity. They specify criteria we must meet or provide guidance in conducting a task. They may, however, give examples or define rules to follow. 

The documentation audit to verify that the documented practices implement the approved policies and the relevant requirements of the standard. 

The implementation audit to verify that the documented practices are being followed and that there are no undocumented practices employed that affect quality. This can be divided into two parts, one addressing upper management and their implementation of the strategic plans and one addressing staff and their implementation of the procedures. 

Formal and documented practices involve repeatable work processes. 

Is there a procedure for periodically evaluating subcontractors for adherence to company requirements for traceability, suitability of method, and documentation practices ... 

Good documentation practices ° Good laboratory practices... 

Employees performing GMP-related tasks should be trained periodically in the principles of GMP that apply to their operation. At least biennially they should be reminded of the documentation practices noted above as well as their responsibility to follow procedures as prescribed. Employees should also be encouraged to inform their supervisor of any incorrectly performed operations. Finally they should be informed that it is necessary to report to their supervisor any illness, especially open lesions, that they have, which may contaminate the excipient during the performance of their responsibilities. Employee GMP training should also be documented. 

The accomplishment of validation in this industry entails many different aspects of operation and quality control, and therefore raises some of the same management issues associated with the organization of any complex activity. Simply put, validation efforts must be properly managed to ensure their effectiveness. Some of the more common methods and documentation practices are outlined below. These are basic validation requirements expected by the FDA as well as foreign bodies. 

Are appropriate documentation practices employed during the execution of the batch record (e.g., steps documented in a timely manner, verification, attached data are present) Are the data complete and accurate ... 

Another element of qualification is the quality audit. Will one be required, and if it is, to what extent A quality audit can be conducted from the sponsor s office through the use of an audit questionnaire. Again, this can be extensive 20-plus page request for information related to the vendor s documentation practices, equipment lists, service capabilities, facility layout, materials control, and personnel credentials, or a three-to-four-page questionnaire identifying such critical requirements as the financial information and industry standards to which the vendor complies. (For an extensive discussion on internal audit programs, see Chap. 12, The Internal Audit Program. )... 

Documentation practices (electronic and paper raw data, specifications, batch records, shipping records, development reports)... 

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). 

Jackson, E. B., Spec. Libraries 51, 115-21 (March 1960). Aeronautical documentation practices in Europe and America. 

Cycle Development does not have to be performed per a written procedure however, the procedure and results of all work must be recorded in laboratory notebooks, performed in accordance with cGMP documentation practices and sound scientific methods, and retained as part of the Validation Package. At the completion of Cycle Development work, a brief Cycle Development Report will be prepared that identifies parameters having a high probability of successfully meeting the Performance Qualification requirements. 

In a regulated environment, proper documentation to support both data and reports is of paramount importance responsibilities for documentation and appropriate documentation practices to support the validation and implementation of LBAs in this regulatory environment are discussed in Chapter 12. 

DeSain C, Sutton CV (1996) Documentation Practices. A Complete Guide to Document Development and Management for GMP and ISO 9000 Compliant Industries. Advanstar Communications Duluth, MN. 

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. 

With the first fund created in 1928 and documented practices of making investment decisions based on moral grounds before that, the practice of taking into account extra-financial criteria when making investment... 

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