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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: Hazardous materials regulatory agencies

SOP for Managing Waste During Emergency Shutdowns

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SOP for Managing Waste During Emergency Shutdowns Standard Operating Procedure for Managing Waste During Emergency Shutdowns 1) Purpose The purpose of this SOP is to provide a structured approach for safely managing waste during emergency shutdowns to prevent environmental contamination, ensure regulatory compliance, and mitigate risks associated with unplanned disruptions in operations. 2) Scope This…

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Environment, Health and Safety

SOP for Use of Autoclaves in Waste Sterilization

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SOP for Use of Autoclaves in Waste Sterilization Standard Operating Procedure for Use of Autoclaves in Waste Sterilization 1) Purpose The purpose of this SOP is to provide guidelines for the proper use, maintenance, and monitoring of autoclaves for sterilizing waste, ensuring safety, compliance, and effective decontamination of biological waste before disposal. 2) Scope This…

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Environment, Health and Safety

SOP for Disposal of Controlled Substances Waste

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SOP for Disposal of Controlled Substances Waste Standard Operating Procedure for Disposal of Controlled Substances Waste 1) Purpose The purpose of this SOP is to establish guidelines for the safe, secure, and compliant disposal of waste containing controlled substances to prevent misuse, environmental contamination, and ensure adherence to regulatory requirements. 2) Scope This SOP applies…

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Environment, Health and Safety

SOP for Using Secondary Containment Systems for Liquid Waste

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SOP for Using Secondary Containment Systems for Liquid Waste Standard Operating Procedure for Using Secondary Containment Systems for Liquid Waste 1) Purpose The purpose of this SOP is to establish guidelines for the proper use, maintenance, and monitoring of secondary containment systems for liquid waste to prevent leaks, spills, and environmental contamination. 2) Scope This…

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Environment, Health and Safety

SOP for Monitoring Air Emissions During Waste Incineration

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SOP for Monitoring Air Emissions During Waste Incineration Standard Operating Procedure for Monitoring Air Emissions During Waste Incineration 1) Purpose The purpose of this SOP is to establish a systematic procedure for monitoring air emissions generated during waste incineration to ensure compliance with environmental standards and minimize the release of harmful pollutants into the atmosphere….

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Environment, Health and Safety

SOP for Segregation of Biological Waste from Chemical Waste

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SOP for Segregation of Biological Waste from Chemical Waste Standard Operating Procedure for Segregation of Biological Waste from Chemical Waste 1) Purpose The purpose of this SOP is to establish a clear procedure for segregating biological waste from chemical waste to prevent cross-contamination, ensure safe handling, and comply with regulatory requirements for waste management. 2)…

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Environment, Health and Safety

SOP for Handling and Disposal of Animal Waste from Preclinical Studies

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SOP for Handling and Disposal of Animal Waste from Preclinical Studies Standard Operating Procedure for Handling and Disposal of Animal Waste from Preclinical Studies 1) Purpose The purpose of this SOP is to establish guidelines for the safe and compliant handling, segregation, storage, and disposal of animal waste generated during preclinical studies. This ensures the…

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Environment, Health and Safety

SOP for Conducting Waste Audits and Inspections

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SOP for Conducting Waste Audits and Inspections Standard Operating Procedure for Conducting Waste Audits and Inspections 1) Purpose The purpose of this SOP is to establish a standardized method for conducting waste audits and inspections to assess waste management practices, identify areas of improvement, and ensure compliance with environmental regulations and organizational policies. 2) Scope…

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Environment, Health and Safety

SOP for Training Personnel on Waste Management Procedures

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SOP for Training Personnel on Waste Management Procedures Standard Operating Procedure for Training Personnel on Waste Management Procedures 1) Purpose The purpose of this SOP is to provide guidelines for developing and conducting comprehensive training programs on waste management procedures to ensure employees understand and comply with regulatory, environmental, and organizational standards. 2) Scope This…

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Environment, Health and Safety

SOP for Documentation of Waste Management Activities

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SOP for Documentation of Waste Management Activities Standard Operating Procedure for Documentation of Waste Management Activities 1) Purpose The purpose of this SOP is to establish a standardized process for documenting all waste management activities, ensuring accurate record-keeping, regulatory compliance, and traceability of waste generation, storage, transportation, and disposal. 2) Scope This SOP applies to…

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Environment, Health and Safety

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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
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Capsules V 2.0
  • Creams 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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