Artikel Review: Intermediate Product Sampling Pattern Planning in the Validation Process

Abstrak

The pharmaceutical industry must be able to ensure certainty in the production process through validation throughout the production process. Therefore, it is necessary to carry out process validation to ensure that every parameter and procedure used in each intermediate product production process obtains results that meet the requirements and specifications required. A sample is one of the guidelines in conducting process validation, so it is necessary to plan to determine the collection location based on risk and scientific reasons. This review aims to provide information on the tools used during the sampling process and the number of sample points taken on solid, semi-solid, and non-sterile liquid drug product preparations. Hopefully, this review can be a consideration for the pharmaceutical industry in planning sampling for the intermediate product during process validation. The method used is a library search from databases available online from ScienceDirect and standards from authoritative institutions. The results obtained in this review are tools that can be used in sampling patterns for solid preparations, namely thief samplers, simple bag-sampling spears, and scoop and for liquid and semi-solid non-sterile preparations, dip tubes and weighted containers. In the sampling pattern during the mixing process of the solid, there are 10 locations of sampling. While in the sampling pattern during the process of mixing liquid and semi-solid non-sterile, there are 9 locations of sampling. With this validity, it can represent the consistency of product quality.