To lay down the procedure for receiving the samples in microbiology lab.
It is applicable to microbiology lab.
Head of Department
5.1 Water Samples
5.1.1 Microbiology personnel shall perform the sampling and collection of the samples required for microbiology and chemical testing.
5.1.2 After collection of the samples microbiology personnel shall allot the A.R No in the respective register.
5.1.3 Samples shall be transferred to the respective testing area.
5.2 Finish and In Process samples
5.2.1 The finished and In process samples comes into in quality control lab through quality assurance department shall be received by microbiology personnel and the allotted A.R No is entered in the respective register.
5.3 Raw material (API / Excipient)
5.3.1 The chemical / microbiology personnel shall perform the sampling of raw material (API / Excipient). The shall be received by microbiology personnel and the allotted A.R No is entered in the respective register.
5.5 Miscellaneous samples
5.5.1 The miscellaneous samples such validation samples, hold time samples and primary packaging samples are received in microbiology lab through quality assurance department or sampled by microbiologist.
5.5.2 After receiving the sample the entry is done in the miscellaneous register and A.R No is allotted and the samples are distributed for testing.
5.5.3 Allot the Analytical Report No. (AR. No.) as per the SOP.
5.5.4 Enter the detail of the sample and A.R No in Annexure.
SOP - Standard operating procedure
A.R.No. - Analytical Report Number
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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