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