Page 3 - Quality control of pharmaceuticals (07-PA 704) practical

I. INTRODUCTION TO MICROBIOLOGICAL QUALITY CONTROL IN
PHARMACEUTICAL INDUSTRIES

❖ Responsibilities of Quality control in pharma industry

o QC is responsible for the day-to-day control of quality within the company.
o Analytical testing of incoming raw materials and inspection of packaging

components, including labelling.
o Conduct in-process testing when required, perform environmental monitoring and

inspect operations for compliances.
o Conduct tests on finished dosage forms.
o Selection of qualified vendors from whom raw materials are purchased.
o Testing of representative samples is required, and in many cases, an audit of

vendor's operations is necessary to determine their suitability and degree of
compliance with GMPs prior to their being approved.

❖ Pharmaceutical Microbiology Scope

o Study of microorganisms associated with the industry:
o Control and monitor microorganism through the process to ensure the safe

manufacturing of pharmaceutical products:
o Microbiological Analysis Tests
o Environmental monitoring

❖ Sources of microbial contamination in pharmaceutical industry:

o Raw materials
o Water supply
o Air
o Equipment
o Personnel
o Packaging

❖ Activities in Microbiology lab

o Media Preparation
o Media Growth Promotion
o Microbiological Analysis Tests:

▪ Microbial Limit Tests
▪ Sterility Test
▪ Bacterial Endotoxin Test
o Viable Environmental Monitoring
o Rapid Microbiological Methods

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