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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Quality Assurance

Quality Assurance (QA) serves as the bedrock of the pharmaceutical industry, ensuring that pharmaceutical products consistently meet the highest standards of safety, efficacy, and quality. QA encompasses a comprehensive set of processes, procedures, and systems designed to monitor, evaluate, and improve every aspect of drug development, manufacturing, and distribution. By implementing stringent QA measures, pharmaceutical companies can identify and mitigate potential risks, errors, and deviations throughout the product lifecycle. QA protocols encompass rigorous testing, validation, and documentation practices, ensuring compliance with regulatory requirements and industry standards. Moreover, QA fosters a culture of continuous improvement and innovation, driving advancements in manufacturing technologies, quality control methodologies, and patient-centered approaches. Ultimately, the importance of QA in the pharmaceutical industry lies in its ability to safeguard patient health, uphold regulatory compliance, and maintain public trust in the integrity and reliability of pharmaceutical products.

SOP for Laboratory Sample Management

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This SOP outlines the procedures for the handling, storage, tracking, and disposal of laboratory samples to ensure sample integrity, traceability, and compliance with regulatory requirements in pharmaceutical testing and analysis.
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Quality Assurance

Quality Assurance: SOP for Validation of Cleaning Procedures in Gels Production

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SOP for Validation of Cleaning Procedures in Gels Production Standard Operating Procedure for Validation of Cleaning Procedures in Gels Production 1) Purpose The purpose of this SOP is to define procedures for validating cleaning processes in gels production to ensure equipment is effectively cleaned and maintained. 2) Scope This SOP applies to the Quality Assurance…

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Quality Assurance

Quality Assurance: SOP for Endotoxin Testing in Aseptic Gels

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SOP for Endotoxin Testing in Aseptic Gels Standard Operating Procedure for Endotoxin Testing in Aseptic Gels 1) Purpose The purpose of this SOP is to establish procedures for detecting and quantifying endotoxin levels in aseptic gels to ensure product safety and compliance. 2) Scope This SOP applies to the Quality Control (QC) department responsible for…

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Quality Assurance

Quality Assurance: SOP for Sterility Testing in Aseptic Gels

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SOP for Sterility Testing in Aseptic Gels Standard Operating Procedure for Sterility Testing in Aseptic Gels 1) Purpose The purpose of this SOP is to define procedures for conducting sterility testing on aseptic gels to ensure they are free from viable microorganisms. 2) Scope This SOP applies to the Quality Control (QC) department responsible for…

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Quality Assurance

Quality Assurance: SOP for Foreign Particulate Matter Testing in Gels

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SOP for Foreign Particulate Matter Testing in Gels Standard Operating Procedure for Foreign Particulate Matter Testing in Gels 1) Purpose The purpose of this SOP is to establish procedures for detecting and quantifying foreign particulate matter in gels to ensure product safety and quality. 2) Scope This SOP applies to the Quality Control (QC) department…

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Quality Assurance

Quality Assurance: SOP for Specific Gravity Testing in Gels

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SOP for Specific Gravity Testing in Gels Standard Operating Procedure for Specific Gravity Testing in Gels 1) Purpose The purpose of this SOP is to define procedures for determining the specific gravity of gels to ensure consistency and quality. 2) Scope This SOP applies to the Quality Control (QC) department responsible for performing specific gravity…

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Quality Assurance

Quality Assurance: SOP for Water Activity Testing in Gels

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SOP for Water Activity Testing in Gels Standard Operating Procedure for Water Activity Testing in Gels 1) Purpose The purpose of this SOP is to establish procedures for measuring water activity in gels to assess product stability and quality. 2) Scope This SOP applies to the Quality Control (QC) department responsible for performing water activity…

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Quality Assurance

Quality Assurance: SOP for Preservative Content Testing in Gels

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SOP for Preservative Content Testing in Gels Standard Operating Procedure for Preservative Content Testing in Gels 1) Purpose The purpose of this SOP is to define procedures for testing preservative content in gels to ensure efficacy and compliance with regulatory requirements. 2) Scope This SOP applies to the Quality Control (QC) department responsible for performing…

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Quality Assurance

Quality Assurance: SOP for Microbial Limits Testing for Gels

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SOP for Microbial Limits Testing for Gels Standard Operating Procedure for Microbial Limits Testing for Gels 1) Purpose The purpose of this SOP is to establish procedures for conducting microbial limits testing on gels to ensure compliance with microbiological safety standards. 2) Scope This SOP applies to the Quality Control (QC) department responsible for performing…

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Quality Assurance

Quality Assurance: SOP for Finished Product Testing for Gels

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SOP for Finished Product Testing for Gels Standard Operating Procedure for Finished Product Testing for Gels 1) Purpose The purpose of this SOP is to define procedures for conducting finished product testing on gels to ensure they meet quality specifications before distribution to customers. 2) Scope This SOP applies to the Quality Control (QC) department…

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Quality Assurance

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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