GLP implementation

Initially there is some confusion as some people suddenly realize that GLP implementation is about to become a reality and that they must learn "what this is all about." In addition it may happen that one person (hopefully no more) will "actively" or covertly resist. The policy regarding these persons should be to be consistently firm but not confrontational. You should be willing to lose many battles as long as you win the war. It should be stressed that if people have been kept informed and if the Preparation Phase was adequate, most people will cooperate and assist in bringing the laboratory Into compliance. The "resistors" are a small minority whose influence wanes and who eventually will become cooperative. "Resistors" eventually become clear and surprisingly, vocal, supporters of the GLPs. 

The decision to introduce GLP will be formulated in a policy document which identifies the individuals who will act as test facility management under the GLP regulations. The advice of a Quality Assurance expert will also have to be sought already at this stage of GLP implementation. 

The implementation of GLP has to be connected very early on with the distribution of the various responsibilities. Certain tasks require somebody to be in absolute control over their initiation, development, implementation and conclusion. Where the (external or part-time) Quality Assurance expert may not provide for sufficient co-ordination between the various issues to be tackled, then somebody should be nominated for this function, and should be made responsible for the orderly development of GLP implementation. 

Most testing labs will already have detailed mechanisms in place for sample and data handling, which are GLP-compliant based on a network of SOPs covering all aspects of GLPs. It is still important, however, that audits are carried out by the sending laboratory before final selection of a testing lab is made, to ensure that the GLP implementation, required instrumentation, handling of samples, and data are acceptable. 

The GLP training should consist of two parts first, a classroom presentation of the materials described in Section 4 above, and second, a field training session where the principals of documentation of mixing, calibration, and applications can be demonstrated. Disposal, cleaning, and maintenance procedures should also be discussed and demonstrated. The classroom presentation should stress that the four key areas to successful implementation of GLPs are (1) Good Science, (2) Documentation,... 

Several important aspects relevant to the implementation of fast LC technologies in pharmaceutical laboratories should be mentioned. First, increases in speed should not compromise the quality of the analytical data or the robustness of the chromatography. All methods must be reproducible and validatable to meet the applicable GMP and GLP requirements. Instrumentation should be easily maintained and have minimal downtime. 

To date, the Part II Programme has focused upon four major projects (1) The development and implementation of a set of Principles of Good Laboratory Practice (GLP s) (2) Resolution of issues concerning Confidentiality of Data (3) Development of a Glossary of Key Terms and (4) Development of guidelines and other procedures for the exchange of information (e.g., re test data, the export of hazardous chemicals, and the labelling of hazardous chemicals). 

This chapter provides a general discussion of aU aspects of FDA s GLP regulations, as amended to September 13, 1991. Where appropriate, FDA interpretations are presented for specific sections of the GLP regulations. For critical parts of the regulations, a more in-depth discussion is provided, including means for implementation and an evaluation of positive and negative impacts on the conduct of GLP-regulated studies. 

If the decision is to implement the GLP system across the organization the cost and time commitment is signifi-... 

In conclusion, implementing GLPs in a contract laboratory can be successful and rewarding for the company. There must be a strong management and staff commitment to achieve and maintain compliance, however. 

IMPLEMENTING GLPs IN A CAPTIVE OR CORPORATE ANALYTICAL LABORATORY... 

The decision to implement GLPs in a captive or corporate laboratory is not very different from the decision in a contract-independent laboratory, especially if the lab is run as a separate business unit or profit center. In making the decision, however, management must take additional factors into account. 

For a non-GLP facihty to implement these standards, management must therefore commit to hire or train staff who can function as study directors and must have a separate, Copyright 2003 Marcel Dekker, Inc. 

As mentioned earlier, when estabhshing GLP standards in a non-GLP lab, the first decision is whether or not to implement the requirements across the entire organization or only in some technical areas. A key element of compliance with GLP is that adequate facilities and equipment are available for the projects, so the laboratory may face a chicken and egg dilemma, particularly when venturing into GLP projects for the first time. 

Equipment used in GLP studies must be validated for appropriateness. Each piece of equipment must have SOPs for operation, calibration, and routine maintenance. All routine and nonroutine maintenance must be documented. What is the definition of a piece of equipment Any item that can have an impact on the results of an anal5dical procedure. In the typical non-GLP laboratory, records are kept on analytical equipment such as spectrophotometers or gas chromatography units. Under GLP, however, the definition expands to include items such as pipets, thermometers, incubators, refrigerators, and mixing devices, as long as it is possible that the use of the item can affect the outcome of the test. For the non-GLP lab, implementation of this standard will dramatically increase the number of equipment-related SOPs. 

The GLP standards specify that the laboratory must have SOPs for particular activities at a minimum. Most laboratories find that implementation of GLPs will cause a dramatic increase in the number of SOPs used by the facility. They are an effective and easy way to document a procedure and to ensure that the staff is trained in the correct procedure. Standard Operating Procedures are hving documents and require care and maintenance however. 

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