Year: 2020

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 Operation and Cleaning Of Compression Machine

Standard Operating Procedure (SOP) for Cleaning and Operation Procedure for double rotary Tablet Compression Machine (45 And 55 Station). Operation and Cleaning Procedure of Tablet Compression Machine PURPOSE: To lay down the efficient cleaning and operation of Double rotary compression machine Cadpress 45/55 stations Mark IV. SCOPE: This procedure is applicable for the cleaning and …

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SOP for Sampling of Packing Material

Standard Operating Procedure (SOP) for the sampling of packing material (Primary Packing Material, Secondary Packing Material, and Tertiary Packing Material). Procedure for Sampling and AQL of Packing Material PURPOSE: The purpose of this SOP is to define the procedure for sampling and acceptance Quality level of packing materials. SCOPE: This SOP is applicable for sampling …

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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 Vendor Management

The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after the approval process considered as an approved vendor. Vendor management consists of the Identification, Qualification, Requalification, management of changes at the vendor site, Vendor Audit, Technical Agreement, Deregistration Process, etc. Vendor Management   PURPOSE: The …

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Acceptable Quality Level (AQL) – SOP and Chart

OBJECTIVE: To define the procedure for Acceptable Quality Level sampling for Tablets and Capsules during bulk approval. SCOPE: This procedure is applicable to bulk approval of manufactured Tablets and Capsules at pharmaceutical product manufacturing location.     REFERENCES: ISO 2859-1:1999(en) Sampling procedures for inspection by attributes SOP for Event Reporting and Investigation. DEFINITIONS OF TERMS: …

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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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