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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: Regulatory Compliance

SOP for Regulatory Submission Process

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Standard Operating Procedure (SOP) for Regulatory Submission Process Purpose: The purpose of this SOP is to establish a standardized process for the regulatory submission of documents and data to health authorities, ensuring compliance with applicable regulations and guidelines. Scope: This SOP applies to all personnel involved in the regulatory submission process within the organization. Responsibilities:…

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Quality Assurance

Regulatory Affairs: SOP for Regulatory Submission Process

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1. Purpose: The purpose of this SOP is to provide a systematic approach to the regulatory submission process within our organization. 2. Scope: This SOP applies to all employees involved in the regulatory submission process, including but not limited to regulatory affairs personnel, project managers, clinical operations personnel, and quality assurance personnel. 3. Responsibilities: The…

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Regulatory Affairs

SOP for Regulatory Document Formatting and Templates

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Standard Operating Procedure (SOP) for Regulatory Document Formatting and Templates Purpose: The purpose of this SOP is to establish guidelines and procedures for ensuring consistent formatting, structure, and content of regulatory documents within the organization. This SOP aims to facilitate efficient document creation, review, and submission while adhering to regulatory requirements and maintaining a professional…

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Regulatory Affairs

SOP for Operation of BOD Incubator

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Standard Operating Procedure (SOP): Operation of BOD Incubator Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and efficient operation of a Biological Oxygen Demand (BOD) incubator in a laboratory setting. The BOD incubator is used to maintain controlled environmental conditions for incubation of samples to measure oxygen…

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Microbiology Testing, Quality Control

SOP for Operation of Hot Water Bath

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Standard Operating Procedure (SOP): Operation of Hot Water Bath Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and effective operation of a hot water bath in a laboratory setting. The hot water bath is used for various applications such as sample heating, thawing, and maintaining constant temperature…

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Quality Control

SOP for Operation of Laboratory Autoclave

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SOP for Operation of Laboratory Autoclave Standard Operating Procedure (SOP): Operation of Laboratory Autoclave Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and effective operation of a laboratory autoclave. This SOP ensures proper sterilization of laboratory equipment, media, and waste to maintain aseptic conditions. Scope: This…

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Microbiology Testing, Quality Control

SOP for Operation of Centrifuge Machine

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Standard Operating Procedure (SOP): Operation of Centrifuge Machine Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and efficient operation of a centrifuge machine. This SOP ensures consistent and controlled separation of substances based on their density in a laboratory or testing environment. Scope: This SOP applies…

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Quality Control

SOP for Operation of Bacteriological Colony Counter

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Standard Operating Procedure (SOP): Operation of Bacteriological Colony Counter Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and accurate operation of a bacteriological colony counter. This SOP ensures consistent and reliable counting of bacterial colonies in a laboratory or testing environment. Scope: This SOP applies to…

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Microbiology Testing, Quality Control

SOP for Operation of Muffle Furnace

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Standard Operating Procedure (SOP): Operation of Muffle Furnace Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and effective operation of a Muffle Furnace. This SOP ensures consistent and accurate heat treatment, ashing, or high-temperature operations on various materials in a controlled environment. Scope: This SOP applies…

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Quality Control

SOP for Operation of Heating Oven

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Standard Operating Procedure (SOP): Operation of Heating Oven Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and efficient operation of a Heating Oven. This SOP ensures consistent and controlled heating of materials or samples to specific temperatures in a laboratory or testing environment. Scope: This SOP…

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Quality Control

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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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