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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 …

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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 …

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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 …

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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 …

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SOP on Procedure for operation and cleaning of unit dosage sampler

SOP on Procedure for operation and cleaning of unit dosage sampler OBJECTIVE To lay down the procedure for operation and cleaning of unit dose sampler. SCOPE This SOP shall be applicable for IPQA area in Quality Assurance. RESPONSIBILITY In process Quality Assurance Executive /Officer ACCOUNTABILITY Head Quality Assurance PROCEDURE FOR …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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

OBJECTIVE  To lay down the procedure for operation of HPLC (Waters Alliance  2695 Separation Module) SCOPE To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the HPLC system (Waters Alliances 2690 / 2695 Separation Modules . RESPONSIBILITY Quality Control Officer/Executive. …

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SOP on Procedure for operation of analytical balance

OBJECTIVE To lay down a procedure for operating and cleaning of analytical balance) SCOPE This SOP shall provide the Operating procedure of analytical balance of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Description of balance: XS 204 DR is analytical class balance with a …

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SOP on Operating procedure for tap density apparatus make : electrolab

OBJECTIVE To lay down the procedure for Operation of Tap density apparatus, Make Electro lab. SCOPE This SOP shall provide the Operating procedure of Tap density apparatus of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Before starting the operation Check for the area cleanliness …

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SOP on Operating procedure for sieve shaker in quality control

SOP on Operating procedure for sieve shaker in quality control OBJECTIVE To lay down the procedure for Operation of Mechanical Sieve Shaker, Make Electro Lab. SCOPE This SOP shall provide the Operating procedure of Mechanical Sieve Shaker of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control. ACCOUNTABILITY Head QC/QA. …

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Procedure for calibration of Instruments/ Equipments.Quality Assurance

OBJECTIVE : To lay down policy for calibration of Instruments/Equipments. RESPONSIBILITY : Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any. Heads of the  concerned department to ensure compliance. Procedure : All the instruments associated with the processing and testing of materials and products …

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Operation qualification protocol for air handling unit & air distribution system

Purpose: The purpose of this protocol is: To verify the operational attributes of the Heating Ventilation and Air Conditioning system, critical to serve the intended purpose. To establish the suitability of the draft SOP prepared for the operation of System. To document the observations for future reference. Requalification: Operational Qualification …

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Installation qualification protocol for air handling unit & air distribution system

  OBJECTIVE The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure and  guidelines and respective acceptance criteria for the Installation and Operational Qualification of Air handling unit . The Air-Handling unit caters to:- AREA DETAILS Sr. No Name of the area …

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SOP on cleaning of production area footwears.

Objective The SOP describes cleaning procedure for footwear used in production area. Scope This SOP is applicable for the cleaning procedure for footwear used in production area. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations IPA  :  Isopropyl alcohol Description Cleaning …

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SOP for operation, cleaning and maintenance of Fogger.

Objective To lay down the procedure for operation, cleaning and maintenance of Fogger. Scope This SOP is applicable for the operation, cleaning and maintenance of Fogger used in the Aseptic area of Sterile Injectable Facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for compliance of SOP. …

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