Explain the good practices related to prevention of Mix-ups and Cross Contamination in production of Pharmaceuticals.
Answers
The scope of this study is to explore the understanding of Prevention of Contamination and Cross-Contamination in Pharmaceutical Dosage forms. The pharmaceutical products manufacturer must reproduce consistently the desired quality of products.
The current Good Manufacturing Practice (cGMP) regulation recognizes that Contamination and Cross-Contamination of pharmaceutical products must not occur. The control of cross-contamination plays a very important role in maintaining the quality of product.
The manufacturing of pharmaceutical products involves series of processing steps and use of various equipments. Equipments and ancillary systems may be used for manufacturing multiple products or single dedicated product. The inadequate cleaning process may leads to the fact that, residue may get carried forward as contaminant in the next batch to be manufactured in the same equipment.
In this article we have concentrated mainly on the prevention of cross-contamination, beginning with the definitions of contaminant, contamination and cross-contamination.
Contaminant – An impurity or any substance or material that causes contamination or spoilage.
Contamination – The undesired introduction of impurities of a chemical or microbiological nature or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging, repacking, storage and transport.
Cross-Contamination – Contamination of a starting material, intermediate product, finished product with another starting material or a product.
The most typical sources of contamination are – Premises and design of building, People, HVAC system, Manufacturing Operations, Clothing, Utilities and Services. We hope, all the pharmaceutical manufacturers of different dosage forms follow cGMP Guidelines but, even there is possibility of ignoring these points. We have briefly highlighted the preventive measures of cross-contamination on the above mentioned points.
The scope of this study is to explore the understanding of Prevention of Contamination and Cross-Contamination in Pharmaceutical Dosage forms. The pharmaceutical products manufacturer must reproduce consistently the desired quality of products.
The current Good Manufacturing Practice (cGMP) regulation recognizes that Contamination and Cross-Contamination of pharmaceutical products must not occur. The control of cross-contamination plays a very important role in maintaining the quality of product.
The manufacturing of pharmaceutical products involves series of processing steps and use of various equipments. Equipments and ancillary systems may be used for manufacturing multiple products or single dedicated product. The inadequate cleaning process may leads to the fact that, residue may get carried forward as contaminant in the next batch to be manufactured in the same equipment.
In this article we have concentrated mainly on the prevention of cross-contamination, beginning with the definitions of contaminant, contamination and cross-contamination.
Contaminant – An impurity or any substance or material that causes contamination or spoilage.
Contamination – The undesired introduction of impurities of a chemical or microbiological nature or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging, repacking