Manufacture of Formulated Preparations

Manufacture of Formulated Preparations
Attention is drawn to the need to observe adequate hygienic precautions in the preparation and dispensing of pharmaceutical formulations. The principles of good pharmaceutical manufacturing practice should be observed.
The Definition in certain monographs for pharmaceutical preparations is given in terms of the principal ingredients only. Any ingredient, other than those included in the Definition, must comply with the general notice on Excipients and the product must conform with the Pharmacopoeial requirements.
The Definition in other monographs for pharmaceutical preparations is presented as a full formula. No deviation from the stated formula is permitted except those allowed by the general notices on Colouring Agents and Antimicrobial Preservatives. Where additionally directions are given under the heading Extemporaneous Preparation these are intended for the extemporaneous preparation of relatively small quantities for short-term supply and use. When so prepared, no deviation from the stated directions is permitted. If, however, such a pharmaceutical preparation is manufactured on a larger scale with the intention that it may be stored, deviations from the stated directions are permitted provided that the final product meets the following criteria:
(1) compliance with all of the requirements stated in the monograph;
(2) retention of the essential characteristics of the preparation made strictly in accordance with the directions of the Pharmacopoeia.
Monographs for yet other pharmaceutical preparations include both a Definition in terms of the principal ingredients and, under the side-heading Extemporaneous Preparation, a full formula together with, in some cases, directions for their preparation. Such full formulae and directions are intended for the extemporaneous preparation of relatively small quantities for short-term supply and use. When so prepared, no deviation from the stated formula and directions is permitted. If, however, such a pharmaceutical preparation is manufactured on a larger scale with the intention that it may be stored, deviations from the formula and directions stated under the heading Extemporaneous Preparation are permitted provided that any ingredient, other than those included in the Definition, complies with the general notice on Excipients and that the final product meets the following criteria:
(1) accordance with the Definition stated in the monograph;
(2) compliance with all of the requirements stated in the monograph;
(3) retention of the essential characteristics of the preparation made strictly in accordance with the formula and directions of the Pharmacopoeia.
In the manufacture of any official preparation on a large scale with the intention that it should be stored, in addition to following any instruction under the heading Production, it is necessary to ascertain that the product is satisfactory with respect to its physical and chemical stability and its state of preservation over the claimed shelf-life. This applies irrespective of whether the formula of the Pharmacopoeia and any instructions given under the heading Extemporaneous Preparation are followed precisely or modified. Provided that the preparation has been shown to be stable in other respects, deterioration due to microbial contamination may be inhibited by the incorporation of a suitable antimicrobial preservative. In such circumstances the label states appropriate storage conditions, the date after which the product should not be used and the identity and concentration of the antimicrobial preservative.