Pharmaceutical products precautions

Contains condensed information on every pharmaceutical product available in New Zealand, including details on pharmacological action, therapeutic indications, contraindications, precautions, adverse reactions and interactions. Provided free to medical practitioners and chief hospital pharmacists. Also available on subscription. Published three times a year. ADIS International, Private Bag 65901, Mairangi Bay, Auckland 10, NewZealand. 

Process of identifying a pharmaceutical product including the following information, as appropriate name active ingredient(s), type and amount batch number expiry date special storage conditions or handling precautions directions for use, warnings and precautions names and addresses of the manufacturer and/or the supplier (adapted from GMP. ... 

Written procedures for the dispatch of pharmaceutical products should be established. Such procedures should take into account the nature of the product, as well as any special precautions to be observed. 

Stringent precautions should be taken to ensure that rejected materials and pharmaceutical products cannot be used. Rejected goods should be clearly marked as such and stored separately from other materials and pharmaceutical products in a locked compound accessible only to authorized and trained responsible personnel, while the materials await destruction or return to the supplier. Whatever action is taken should be approved by authorized personnel and recorded. Rejected materials should be handled in accordance with a written procedure. 

All stock should be checked regularly for obsolete and outdated materials and pharmaceutical products. All due precautions should be observed to prevent issue of outdated materials and pharmaceutical products. The handling of such materials should be subject to a written procedure. 

Rules for dispatch procedures should be established according to the nature of the materials and pharmaceutical products being dispatched and after taking into account any special precautions to be observed. Any special packaging requirements for movement of goods must be met. Some goods may require special protection before they can be shipped by boat or by air. All legislation that may affect these requirements must be fulfilled. 

For pharmaceutical products that can be sterilized in their final containers, the above requirements are necessary with the exception of the need to sterile-filter the air. Special precautions shall be taken to assure that there will be no mix-up between those products awaiting sterilization and those products already sterilized. 

PROCEDURES Description of the operations to be carried out the precautions to be taken and measures to be applied directly or indirectly related to the manufacture of a pharmaceutical product... 

The manufacture of biological pharmaceutical products involves certain specific considerations arising from the nature of the products and the processes. The way in which biological pharmaceutical products are produced, controlled and administered make some particular precautions necessary. 

The risk of cross-contamination between biological pharmaceutical products, especially during those stages of the manufacturing process in which live organisms are used, may require additional precautions with respect to facilities and equipment, such as the use of dedicated facilities and equipment used will determine the level of segregation needed to avoid cross-contamination. 

With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions. 

The Offlcal Standards, as stipulated in the pharmacopoeias of various countries, e.g., IP BP, Em. R, Int. P, USSRP, JP etc., of a pharmaceutical substance take cognizance of the purity, nature, methods and hazards of manufacture, precautions of storage and ultimately the conditions under which the product is to be used. 

Summary of relevant pharmaceutical data including chemical structural formula, synthetic route of active substcmce(s), structure validation, pharmaceutical description, composition (qualitative and quantitative), ingredient eind finished product specifications (or trial batch characterisation) and analytical methods, method of manufacture and sissembly of product, stability and storage precautions, container description, eUid bioavailability. 

Fixed oils and fats are naturally occurring products, usually of plant origin, that are used extensively in pharmaceutical formulation. They are very susceptible to oxidative decomposition (a process called rancidity) and special precautions must be taken to control their stability and prevent their decomposition. Compounds of this type exist as complex mixtures of structurally similar oils, the composition of which can vary from year to year depending on factors such as climate, time of harvest, etc. Chemically, fixed oils and fats are esters of the alcohol glycerol (propane-1,2,3-triol) with three molecules of long-chain carboxylic acids, called fatty acids, which may all be the same or may differ depending on the oil (Figure 8.15). 

When a new drug comes to market, its properties will be oudined in the SPC, including indications, dosage form, precautions, firequency of dosing, contraindications and side-effect profile. All these features collectively establish the product in the marketplace and form the basis of the brand . The creation of a strong brand image is fundamental to advertising, and this is as true for pharmaceuticals as for any other product. For example. 

Protein drugs are unstable during storage, a condition not commonly found in conventional pharmaceuticals. They are also unstable during production, purification, and formulation. Consequently, handling biotechnology products requires additional precautions and challenges for the scientists involved. 

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