1Research Scholar, Department of Pharmacy, Mandsaur University, RewasDewda Road, SH-31, Mandsaur, Madhya Pradesh - 458001, India. Email: 04.chaitanya@gmail.com
2*Professor, Department of Pharmacy, Mandsaur University, RewasDewda Road, SH-31, Mandsaur, Madhya Pradesh - 458001, India. Email: laxminarayan.patidar@meu.edu.in
Medical products contain the drug substance, or active pharmaceutical ingredient, that is the primary substance in a medicine that elicits the desired therapeutic effect of the drug. Drug substances contaminated with foreign particles are highly hazardous to the health of patients, the impact of which remains undetermined. Thus, there is a need to conduct a study on foreign particle contamination. There are six pharmaceutical quality systems that regulate the production of drug substances. Gap analysis has been evaluated by means of a survey through a structured questionnaire that has been used by Google Forms to survey six pharmaceutical quality systems having pharmaceutical employees. One hundred and eighty-eight respondents filled out 98 good manufacturing practices-related questionnaires, and the analysis revealed that 42 of the 98 questions failed the acceptance test. All the questions posed are aimed at revealing the effectiveness of the system used by the pharmaceutical company at the level of controlling the foreign particle contamination in the drug substance and the extent to which the company complies with the rules and regulations. The results of the survey established the following as the most poorly managed systems: pharmaceutical quality, laboratory control, and production systems. The survey has identified a number of nonconformity aspects that are important in regard to good manufacturing practices. Such a survey gives a clear image of the gaps in six pharmaceutical quality systems, and it will contribute towards strengthen the manufacturing systems and processes of the drug substance.
Keywords: Foreign Particles, Contamination, Active Pharmaceutical Ingredients, Pharmaceutical Standards, Good Manufacturing Practices, Quality Management System.
How to cite this article: Bhatt C, Patidar L. Survey on Foreign Particle Contamination in Drug Substances. Int J Drug Deliv Technol. 2026;16(3): 101-108. DOI: 10.25258/ijddt.16.3.14
Source of support: Nil.
Conflict of interest: None