September 21, 2021: Pharmaceutical Interview Questions and Answers

#AcceptanceCriteriaOfMicrobiologicalQualityNonSterileDosageForm #RisksBecauseOfMicroorganism

1. What are the acceptance criteria for microbiological quality of non-sterile dosage forms and raw materials?

Application	TAMC	TYMC	Specified microorganisms
Non-aqueous preparations for oral use	1000	100	Escherichia coli absent in 1 g or 1 mL
Aqueous preparations for oral use	100	10	Escherichia coli absent in 1 g or 1 mL
Rectal use	1000	100	Need based
Oromucosal use Gingival use Cutaneous use Nasal use Auricular use	100	10	Staphylococcus aureus absent in 1 g or 1 mL Pseudomonas aeruginosa absent in 1 g or 1 mL
Vaginal use	100	10	Staphylococcus aureus absent in 1 g or 1 mL Pseudomonas aeruginosa absent in 1 g or 1 mL Candida albicans absent in 1 g or 1 mL
Inhalation use	100	10	Staphylococcus aureus absent in 1 g or 1 mL Pseudomonas aeruginosa absent in 1 g or 1 mL Bile-tolerant gram-negative bacteria absent in 1 g or 1 mL
Transdermal patches	100	10	Staphylococcus aureus absent in 1 g or 1 mL Pseudomonas aeruginosa absent in 1 g or 1 mL
Raw material for pharmaceutical use	1000	100	Need based

2. What are the risks because of microorganism in the pharmaceutical formulation if not within the acceptable limit?

● Decomposition of the product

● Degradation of product

● Infection to the patient