Pharmacy preparation extent

For the scope and depth of the product file of a pharmacy preparation, no strict rules exist yet. However, the pharmacist should clearly cmmect the solidity of the investigation and documentation to the extent of the risk of a suboptimal design or suboptimal control strategy. A risk based approach leads for instance to the following practical solutions as they occur in the Netherlands. 

Salicylic acid is manufactured on a large scale. In the dye industry it serves for the production of valuable azo-dyes which exhibit great fastness. To some extent these dyes are applied to mordanted fibres. In addition, the acid and its derivatives are widely used in pharmacy. Being a phenolcarboxylic acid it has a powerful disinfecting action (preservative). It has further proved itself an important antirheumatic and an analgetic. The derivative in which the phenolic hydroxyl group is acetylated (aspirin) has become especially popular. The first medicament of the series was the phenyl ester of salicylic acid, salol, which is produced as a by-product in the technical process. The preparation of salicylaldehyde has been described above (p. 235). 

This chapter discusses the formulation and methods of preparation of the most used solid dosage forms that can be prepared in hospital or community pharmacies. The formulation of licensed medicines, particularly tablets and capsules, is discussed to such an extent as it is necessary to understand how they are made in case they may have to be adapted for the preparation of other oral preparations in pharmacies. 

Other types of tablets may require chewing by the patient or dissolution of the active substance in the mouth. The formulation of tablets is discussed to such an extent as is necessary to support the adapting of these products into other oral dosage forms in pharmacies. The preparation of tablets is complex and specialised, hard to perform on a small scale and is therefore beyond the scope of this book. The... 

Section 35.6 describes a large series of PQS elements, each of them with examples from pharmaceutical preparations. The extent of their use in the manufacturing situation or in pharmacies depends on the outcome of risk assessments. As elements they should principally be adhered to in both situations. 

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