SOP

SOP for Rapid Mixer Granular

1.0 OBJECTIVE     To lay down the standard cleaning and operation procedure for Rapid mixer granulator 150 L. 2.0 SCOPE   This SOP describes the cleaning and operation of Rapid mixer granulator 150 L with co-mill installed in production department at EquipmentMakeModel / CapacityEquipment IDRapid mixer granulator 150 LSSPMSigma Gran / 150 LPRD/E004 3.0 RESPONSIBILITY  3.1 Production Department 3.1.1 Production […]

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SOP For Microbial Culture Management

A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions. Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology. Microbial Culture Management Standard Operating Procedure (SOP) PURPOSE: To lay down the procedure

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SOP on Laminar Air flow (LAF) – Operation, Cleaning and Qualification

LAF : Laminar Air Flow –  Airflow which is linear and positive up to working surfaces and thus prevents contamination of surrounding viable/ non viable particulate matter in aseptic handling. The Operation, Cleaning, Maintenance and Qualification of Laminar Air Flow (LAF) shall discussed in below SOP. Laminar Air flow (LAF) – Operation, Cleaning and Qualification

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SOP for Handling of Laboratory Reagents

Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC. Receipt, Storage, and Handling of Laboratory ReagentsPurpose : The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents. Scope : This procedure

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SOP for Polarimeter

Purpose: The purpose of this SOP is to describe the procedure for operation, cleaning, and calibration of the polarimeter.    Scope: This SOP  is applicable to the polarimeter available in the Quality control laboratory at the pharmaceutical drug manufacturing plant. Make: … Model:…. Responsibilities – SOP for Polarimeter: The Analyst shall be responsible for: Operate

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SOP on Procedure for the Operation of Fluidized Bed Dryer (FBD)

OBJECTIVE  : The purpose of this SOP to describe the procedure for the operation of fluidized bed dryer (FBD). SCOPE  : This SOP is applicable for operation of fluidized bed dryer located in the tablet production department at Manufacturing site.. Equipment Name               :  Fluidized Bed Dryer. Equipment ID No.               : Manufactured by                 : RESPONSIBILITY :

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SOP for Qualification of Quality Control analyst

   Objective To provide detail procedure for Analyst qualification of Quality control analyst for the performance verification.     SCOPE:             This SOP is applicable for qualification of Quality Control analyst working in QC laboratory at manufacturing facility.     RESPONSIBILITY:             Manager – Quality Control and Head of Quality assurance is responsible for the qualification of Quality control analyst.

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SOP on Cleaning Validation

OBJECTIVE  : The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting materials and products. SCOPE  : These SOP describe the general aspects of cleaning validation, Normally cleaning validation would be applicable for critical cleaning such as cleaning between manufacturing of one product and another, surfaces that

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