Follow
Objective: To lay down a procedure for setting the frequency of in-house microbial test for raw materials and finished products.
Scope: This SOP is applicable for all the raw materials used and finished products produced in (Company Name).
Responsibility:
=>> Microbiologists are responsible for carrying out the test as per specification.
=>> Overall responsibility for training, implementation & follow-up with the QC Manager or his nominee.
Precautions
=>> Hand gloves and mask should be used while conducting analysis.
=>> All the analysis must be carried out under the laminar air flow workstation to prevent unwanted contamination.
Procedure
=>> In-house microbiological test is applicable to all APIs (Active pharmaceutical ingredients) and finished products for which pharmacopoeial test are not mentioned.
=>> The test shall be performed as per general test procedure (GTP/007, GTP/011 & GTP/015) and the limits of the test shall be as follows:
– Total aerobic microbial count 1000 cfu/g of sample
– Total yeast and mold count 100 cfu/g of sample
– E. coli shall be absent in 1 gram of sample
– Salmonella sp shall be absent in 10 grams of sample
– Staphylococcus aureus shall be absent in 1 gram of sample
– Pseudomonas aeruginosa shall be absent in 1 gram of sample
=>> All APIs of each vendor shall be subjected for microbial limit test and test shall be performed on first three batches, followed by one batch per year or every 10th batch whichever comes first.
=>> For OSD products supplying to the local market, microbiological test on the finished product will be done on the initial 3 batches followed by every 10th batch where there is no pharmacopoeial requirement. In case, there is a pharmacopoeial requirement, microbial test of each batch shall be conducted.
=>> However every batch of finished products to be marketed to Europe and America or any other regulated market shall be tested for microbial quality.
=>> Any additional requirements as per customer specification shall be considered for microbiological analysis of APIs and finished products.
