Quality control active pharmaceutical ingredients

Reliable quality control in the field of pharmaceutical analysis is based on the use of valid analytical methods. For this reason, any analytical procedures proposed for a particular active pharmaceutical ingredient and its corresponding dosage forms shonld be validated to demonstrate that they are scientifically sonnd nnder the experimental conditions intended to be used. Since dissolntion data reflect drng prod-net stability and quality, the HPLC method used in snch tests shonld be validated in terms of accuracy, precision, sensitivity, specificity, rngged-ness, and robustness as per ICH guidelines. 

The reasons behind the validation of cleaning procedures are the assurance of the safety and purity of the product (customer requirement), it is a regulatory requirement in active pharmaceutical ingredient product manufacture, and it assures the quality of the process from an internal control and comphance point of view... 

Control weighting, measuring, monitoring and test equipment that is critical for assuring the quality of intermediates or APIs (active pharmaceutical ingredients) should be calibrated according to written procedures and an established schedules. 

Padl, T. and E. Liptak-Csekey. 1990b. Toxic Degradation Products of Active Ingredients A New Target for Quality Control of Pharmaceutical Preparations. Acta Pharmaceutica Jugoslavica 40 199-206. 

In the pharmaceutical industry, the issue of better control, desirable in itself, is reinforced by the need to assure the regulatory authorities that a continuing supply of active pharmaceutical ingredients (APIs) of high and reproducible quality and bioavailability can be delivered for formulation and finally to the patient. The product image (properties, purity, etc.) of this medicine must be the same as that used in the clinical testing carried out to prove the product s place in the therapeutic marketplace. Some additional comments on regulatory issues are included later in this chapter (Section 1.7). 

We have embraced this relatively modem definition of PAT for the purposes of this chapter. In particular, PAT in this context includes any analytical technique that provides data in real time to manufacturing processes involved in making bulk active pharmaceutical ingredients (APIs) with the primary intent to ensure process control and thus product quality. 

The quality control department as a whole will also have other duties, such as to establish, validate, and implement all quality control procedures, to evaluate, maintain, and store the reference standards for substances, to ensure the correct labelling of containers of materials and products, to ensure that the stability of the active pharmaceutical ingredients and products is monitored, to participate in the investigation of complaints related to the quality of the product, and to participate in environmental monitoring. All these operations should be carried out in accordance with written procedures and, where necessary, recorded. 

Since there are fundamental distinctions between the production of bulk active pharmaceutical ingredients and the formulation of finished pharmaceutical products, the strict application of GMP as set forth in the main part of this guide is not always practical or necessary. The present supplementary guidelines outline procedures and practices that manufacturers should employ to ensure that the methods, facilities, and controls used for the production of active pharmaceutical ingredients are operated or managed so that such products have the quality and purity appropriate for their use in finished pharmaceutical products. 

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