SOP on Control of Microbiological Contamination

1.0 Purpose: This SOP describes the methods used to control the microbial contamination during the manufacture of a drug product batch. 

2.0 Scope: This SOP applies to Quality Control Microbiologist.

3.0 Responsibility:  Quality Assurance Manager to ensure that the procedure is followed.

4.0 Materials and Equipment: As required.

5.0 Procedure: The procedures and conditions required to assure adequate microbial quality varies according to the specific products but are likely to include some, or all, of the following –  

5.01 Microbial monitoring of potentially susceptible raw materials (i.e. natural origin – animal, vegetable or mineral).

5.02 Equipment sanitation procedures that have been proven effective especially for any specific known deleterious or objectionable microorganisms.

5.03 Processing conditions that minimize the potential for microbial growth

5.04 Environmental control including wearing of protective clothing such as gloves and masks, cleaning of filling lines at breaks.

5.05 Formulations to include preservatives.

5.06 The acceptance criteria is based on the history and frequency of  tests performed. 

5.07 Any increase in the microbial contamination from the limits is investigated  and an appropriate action is taken to eliminate the cause, so that it does not effect the quality of the product. 

6.0 Reporting : Quality Control Microbiologist must record the observations and any increase or deviation in the microbial contamination from the acceptance criteria must be reported to Quality Assurance Manager.