Author: Pharma Editor

OBJECTIVE : To lay down the procedure for training and evaluation of QA Officers on SOPs  and cGMP. RESPONSIBILITY : Personnel  who   are  knowledgeable  with   the  subject  by  virtue  of  their qualification and experience. Head -Quality Assurance to ensure compliance. PROCEDURE : All Quality Assurance Officers shall undergo training and qualify on relevant/appropriate   Standard Operating  …

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OBJECTIVE To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY In process Quality Assurance Officer / Executive. ACCOUNTABILITY Head Quality Assurance PROCEDURE START UP Inspect the following areas as per SOP  for…

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OBJECTIVE To lay down the procedure for In-process Controls during Tablet Manufacturing. SCOPE This SOP shall be applicable for in-process controls during tablets manufacturing This SOP shall be applicable to IPQA in Quality Assurance Department. RESPONSIBILITY In process Quality Assurance Executive/Officer. ACCOUNTABILITY Head Quality Assurance. PROCEDURE Carry out line clearance at each stage of operation prior…

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OBJECTIVE To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE This SOP shall be applicable to the IPQA in Quality Assurance Department. RESPONSIBILITY In process Quality Assurance Executive/Officer ACCOUNTABILITY Head Quality Assurance PROCEDURE PREPARATION On completion of intermediate / finished product stage, check that the BMR /BPR is…

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Procedure for line clearances. Quality assurance OBJECTIVE To ensure that the area, equipment and activities required for the manufacturing and packing of pharmaceutical products are free from any potential sources of cross-contamination/mix-ups (Line clearance). SCOPE The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities. Responsibility In –…

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SOP on Procedure for operation and cleaning of unit dosage sampler Precision and accuracy are paramount In pharmaceutical manufacturing, Ensuring that each dosage of a medication contains the correct amount of active ingredient is essential for both patient safety and regulatory compliance. To achieve this level of accuracy, pharmaceutical companies rely on various tools and…

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SOP on Handling of Out of Specification Results in quality control OBJECTIVE To lay down a procedure for handling of Out-of-Specification (O.O.S.) test results generated during the testing. SCOPE These procedures are applicable to all QC testing of raw materials, finished product, and stability samples. RESPONSIBILITY Analyst/ Quality Assurance Manager ACCOUNTABILITY Quality Assurance Manager PROCEDURE…

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SOP on Operating procedure for disintegration test apparatus in Pharmaceutical company OBJECTIVE To lay down a procedure for Operation of Tablet Disintegration Tester (Make –Electrolab Model- ED2AL). SCOPE This Standard Operating Procedure (SOP) is applicable to test the disintegration time of the tablets during in process/ QC samples analysis. RESPONSIBILITY IPQA / QC/Production Executive /…

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OBJECTIVE To lay down a procedure for Operation of Halogen Moisture Balance SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Switch on the mains. Check the level of the instrument by checking the air bubble in level indicator is exactly in…

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OBJECTIVE To lay down a procedure for Operation of Leak Test Apparatus SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Ensure that the leak test apparatus is clean. Check that the desiccator is clean, if need be clean the dessicator…

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OBJECTIVE To lay down a procedure for Operation of Vernier Caliper SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE CLEANING Clean the apparatus with tissue paper after every use. OPERATING  INSTRUCTIONS  : Press the ON/OFF button to switch  on  the…

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