SOP on Procedure for microbiological monitoring of Purified water in pharmaceutical company

OBJECTIVE   To lay down a procedure for microbiological monitoring of raw water and purified water SCOPE: This SOP shall be applicable for sampling and microbial analysis of raw and purified water from all user points. RESPONSIBILITY  Quality Control Executive / Officer ACCOUNTABILITY Quality Assurance Head. PROCEDURE: Sampling of water Sampling of water from various points … Read more

SOP on Procedure for viable air monitoring in pharmaceutical company

SOP on Procedure for viable air monitoring in pharmaceutical company OBJECTIVE To lay down a procedure for environmental monitoring of air. SCOPE This SOP shall provide the procedure for monitoring the viable air borne count. RESPONSIBILITY Quality Control Executive / Officer. ACCOUNTABILITY Head Quality Assurance. PROCEDURE The microbial environmental conditions shall be monitored by Settle … Read more

SOP on In-process control during tablet manufacturing in Pharmaceutical company

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 … Read more

SOP on Sampling of intermediates and finished products in pharmaceutical company

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 … Read more

Procedure for line clearances. Quality assurance

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 – … Read more

SOP on Sampling of raw materials in pharmaceutical company

OBJECTIVE To lay down a procedure for sampling of Raw Materials so as to get a representative sample of the whole lot for analysis. SCOPE This SOP shall be applicable to sampling of all Raw materials. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Head Quality Assurance PROCEDURE On receipt of the Goods Receipt Note (GRN) from warehouse, … Read more

SOP on Samping of packing materials in Pharmaceutical company

OBJECTIVE To lay down a procedure for sampling of packaging materials. SCOPE To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Assurance Manager PROCEDURE On receipt of the Goods … Read more

SOP on Procedure for cleaning and storage of sampling devices

OBJECTIVE  To lay down the procedure for Cleaning and storage of sampling devices. SCOPE This SOP shall be applicable for  Cleaning of all type of Sampling devices. RESPONSIBILITY Quality Control Technician ACCOUNTABILITY Executive / Officer – Quality Control PROCEDURE After the sampling, keep the sampling devices (Sampling rods, sampling spoons and spatulas) in a poly … Read more

SOP on Procedure for operation and cleaning of unit dosage sampler

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 … Read more

SOP on Handling of Out of Specification Results in quality control

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 … Read more

SOP on Operating procedure for disintegration test apparatus in Pharmaceutical company

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 / … Read more

SOP on Operating procedure for friability test appratus

OBJECTIVE To lay down a procedure for Operation of Friability Test Apparatus (Make – Electrolab Model-EF2) SCOPE This Standard Operating Procedure (SOP) is applicable to check the friability of In-process samples/QC samples. RESPONSIBILITY IPQA / QC/Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Clean the apparatus free of dust with dry cloth from out … Read more

SOP on Operating procedure for halogen moisture balance

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 … Read more

SOP on Operating procedure for leak test apparatus in pharmaceutical company

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 … Read more

SOP on Operating procedure for vernier caliper in Pharmaceutical company

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 … Read more

SOP on Procedure for operation of HPLC (waters-alliance)

SOP on Procedure for the operation of HPLC (waters-alliance) In the pharmaceutical industry, where precision and accuracy are non-negotiable, High-Performance Liquid Chromatography stands as a stalwart technology. From drug development to quality control and regulatory compliance, HPLC plays a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical products. As technology continues to … Read more