To lay down the procedure for Sampling, Testing and Approval of Raw material and Finished product of microbiology.
1.0 OBJECTIVE:
To lay down the procedure for Sampling, Testing and Approval of Raw material and Finished product of microbiology.
2.0 SCOPE:
This procedure is applicable for Sampling, Testing and Approval of Raw material and Finished product of microbiology.
3.0 RESPONSIBILITY:
logist : To perform the procedure as per SOP.
ead -Quality Control. : To ensure the compliance of SOP.
4.0 PROCEDURE:
4.1 Sampling procedure for Finished Product:
The quality control department shall receive “request cum analytical report” from manufacturing department and shall inform to microbiology department if the analysis is required.
4.1.2 Microbiological analysis shall be done for all validation batches and or as when required. Microbiological product validation shall be done for all the process validated products and or as per requirement.
4.1.3 Sampling shall be done by the microbiologist.In absence of microbiologist, any Q.C person can carryout the sampling, by following the below procedure.
4.1.4 Requirements:
4.1.4.1 Sterile glass bottles / sterile polyethylene bags
4.1.4.2 Sterile spatula / sampling rod
4.1.4.3 Sterile gloves
4.1.4.4 70 % IPA
4.1.5 Carry all the above items in a sampling kit / poly bag for sampling.
4.1.6 Wear the necessary safety apparels if necessary when entering into the sampling area. and Ensure that the sampling area is cleaned before sampling.
4.1.7 Do the sampling of the finished product in the powder processing area.
4.1.8 Take out the sample bottle / poly bag from the sampling kit and note the name of the sample, batch no., sampling date, manufacture date, expiry or retest date etc.
4.1.9 Wear the gloves and mask and spray 70 IPA on the gloves and wait until it dry.
4.1.10 Open the container carefully and collect the sample with a spatula or with a sampling rod.
4.1.11 Similarly carryout the sampling from all the containers of a same batch to get a composite sample of 10 g / 30 g / required quantity.
4.1.12 During collection of each sample wipe the spatula with 70 % IPA to proceed to the next sample. After sampling seal the container properly.
4.1.13 After sampling bring the sampled bottles to the microbiology lab and carry out the analysis with in 2 - 6 hours from the time of sample collection or store in a refrigerator until the analysis is carried out.
4.1.14 Enter the sampling details in the inward register such as Batch No., A.R.No etc. shall be followed as per Q.C.document.
4.2 Sampling procedure for Raw Materials:
4.2.1 Requirements: Refer to 4.1.4.
4.2.2 Fill the required information on the poly bag or sampling bottle.(as per 4.1.8)
4.2.3 Wear the safety apparels and ensure that the sampling booth is cleaned.
4.2.4 Put on the LAF 15 minutes before sampling and check the pressure of magnehelic guage. The pressure should be between 10-20 mm for HEPA filter and 0-10 mm for intermediate & pre filter.
4.2.5 Randomly select the containers from quarantine area and take them into sampling booth for sampling, if quarantine label is affixed on containers / bags for each consignment.
4.2.6 Sampling shall be done as ?n ? 1 for more than 3 containers, where n is the number of container. Sampling shall be done less than or equal to three containers.
4.2.7 Take approximate 30 g composite sample. Use black bag if the material is light sensitive.
4.2.8 Microbiological analysis for raw materials shall be done as per requirement only.
4.3 Testing:
4.3.1 Pretreatment: For freely soluble samples:
Dissolve or suspend 10 g or 10 ml of the sample to be examined in 90ml of sterile Lactose broth media or buffered sodium chloride peptone solution with 0.1% Twin 80.
4.3.2 Pretreatment: For samples with antibiotics:
Dilute or dissolve 10g or 10 ml of the sample in 90 ml of sterile Lactose broth media or buffered sodium chloride peptone solution with 0.1% Twin 80. Addition of ? beta lactamase is preferred in case of products having antibiotic nature.
4.3.3 Membrane filtration Method & Pour plate method:
Follow the procedure as per the current Respective sop.
4.3.4 Limits: As per individual monograph
4.4 For specified Microorganisms.
ple examined to be free from following pathogens as per individual
Monograph:
Escherichia coli,
Salmonella sps,
ococcus aureus,
Pseudomonas aeruginosa,
Enterobacteria.
procedure as per GTP No. Respective sop.
4.5 Approval:
4.5.1 Analyst shall put sign and date as analyzed by in inward register.
The final test report shall be prepared, checked and approved by QC.
4.5.3 QC head or his deputy shall approve / reject the batch, by keeping sign and date in approved by column of the finished product test report.
Raw material , testing, pre filter, microbiology
