Good preparation practices

This chapter outlines the general aspects of premises designed for pharmaceutical preparatitMi activities and the steps to consider in order to achieve a justified design, construction and qualification of these premises. Also the built-in technical facilities are discussed. Premises and its technical facilities are an essential link in achieving good preparation practice. Their design and qualities should be derived from the kind of products that will be produced in it. 

Lactic acid is generally recognized as safe (GRAS) for multipurpose food use. Lactate salts such as calcium and sodium lactates and esters such as ethyl lactate used in pharmaceutical preparations are also considered safe and nontoxic (7). The U.S. Food and Dmg Administration fists lactic acid (all isomers) as GRAS and sets no limitations on its use in food other than current good manufacturing practice (46). 

Only synthetically prepared Ti02 can be used as a color additive. It is permitted ia foods to 1% and is used to color such products as confectionary paimed goods, cheeses, and icings. It is also widely used ia tableted dmg products and ia numerous cosmetics such as Upsticks, nail enamels, face powder, eye makeup, and rouges, ia amounts consistent with good manufactuting practice (42). 

Prompted by new regulation, industry standards, and good business practice, our corporate safety staff has prepared recommendations for the Core Management Group concerning Process Safety Management (PSM). 

Good manufacturing practices for pharmaceutical products. In WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823, Annex 1). 

For good manufacturing practice, some aspects have to be considered before application that involve the constituents of the sample solntion the property of the solvent used for dissolution, and the concentration of the solntion applied onto the layer. It must be clear that the application pattern is completely different for preparative purposes in contrast to analytical separations. Mannal application by well-trained analysts is especially helpful for highly concentrated solntions. Benefits of proper instrumentation are shown, and guidance is provided for choosing the proper instrument and crucial parameters that are involved. 

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. 

Plot maintenance B Expertise must be available to maintain the test site and, if cropped, to take care of the crop For bare-soil studies, the soil surface must be carefully prepared prior to test substance application and kept weed-free without disturbing the test areas. If the test is cropped, the crop should be treated according to Good Agricultural Practice. In case of a soil accumulation study, the field may be cultivated and cropped each season for up to 6 years... 

Internal quality control is undertaken by the inclusion of particular reference materials, called control materials , into the analytical sequence and by duplicate analysis. The control materials should, wherever possible, be representative of the test materials under consideration in respect of matrix composition, the state of physical preparation and the concentration range of the analyte. As the control materials are treated in exactly the same way as the test materials, they are regarded as surrogates that can be used to characterise the performance of the analytical system, both at a specific time and over longer intervals. Internal quality control is a final check of the correct execution of all of the procedures (including calibration) that are prescribed in the analytical protocol and all of the other quality assurance measures that underlie good analytical practice. IQC is therefore necessarily retrospective. It is also required to be as far as possible independent of the analytical protocol, especially the calibration, that it is designed to test. 

Documents of special importance in providing guidelines and standards for pharmaceutical compounding include the National Association of Boards of Pharmacy s "Good Compounding Practices Applicable to State Licensed Pharmacies " the USP 27/NF 22 Chapter 795, "Pharmacy Compounding — Nonsterile Preparations " and Chapter 797, "Pharmacy Compounding — Sterile Preparations " as well as numerous other portions of the USP/NF. 

General provisions contain recommendations that are considered the minimum current good compounding practices for the preparation of drug products by state-licensed pharmacies for dispensing or administration to humans or animals. The document contains definitions of compounding and manufacturing. 

A final report should be prepared after the completion of each laboratory activity. The final report should be signed and dated by the laboratory director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with the principles of good laboratory practice should be indicated. 

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

In accordance with Article 10 of Council Directive 92/25/EEC, a guideline has been prepared on Good Distribution Practice of medicinal products... 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

Finally, radiopharmaceuticals are often prepared on a daily basis within the framework of clinical studies which often last several months or years. They demand a viable and reproducible production chain, leading to a sterile- and pyrogen-free radiopharmaceutical of high radiochemical purity. Therefore, microprocessor-controlled automated synthesis devices [31] are developed in order to ensure routine pharmaceutical production. They are becoming mandatory in order to meet the demands related to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). 

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