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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Injectables

SOP for Personal Protective Equipment (PPE) Usage

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The purpose of this SOP is to establish guidelines for the proper selection, use, and maintenance of personal protective equipment (PPE) to ensure personnel safety during pharmaceutical manufacturing operations.
Click to read the full article.

Injectables

SOP for Sterilization Procedures for Manufacturing Equipment

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The purpose of this SOP is to establish guidelines for the sterilization of manufacturing equipment to ensure microbial control and product quality in pharmaceutical manufacturing.
Click to read the full article.

Injectables

SOP for Quality Control Testing of IV Injections

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The purpose of this SOP is to define the procedures for quality control testing of intravenous (IV) injections to ensure they meet specifications for safety, efficacy, and quality.
Click to read the full article.

Injectables

SOP for Handling Deviations during Manufacturing

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The purpose of this SOP is to establish procedures for identifying, documenting, evaluating, and managing deviations from established manufacturing processes to ensure product quality and compliance.
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Injectables

SOP for Training of Personnel in Aseptic Manufacturing

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The purpose of this SOP is to establish procedures for the training and qualification of personnel involved in aseptic manufacturing processes to ensure competency and adherence to aseptic techniques.
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Injectables

SOP for Documentation and Record Keeping in Manufacturing

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The purpose of this SOP is to establish guidelines for the documentation and recordkeeping practices in pharmaceutical manufacturing to ensure accuracy, traceability, and compliance with regulatory requirements.
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Injectables

SOP for Storage Conditions for Finished Products

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The purpose of this SOP is to define the procedures for the storage of finished pharmaceutical products to maintain their integrity, stability, and quality throughout the storage period.
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Injectables

SOP for Visual Inspection of Finished Products

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The purpose of this SOP is to establish procedures for the visual inspection of finished pharmaceutical products to ensure they meet quality standards before release for distribution.
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Injectables

SOP for Cleaning Validation in Manufacturing Area

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The purpose of this SOP is to define the procedures for cleaning validation in the pharmaceutical manufacturing area to ensure removal of residues and contaminants from equipment and surfaces.
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Injectables

SOP for Gowning Procedures in Cleanroom Environment

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The purpose of this SOP is to define the procedures for gowning in a cleanroom environment to prevent contamination of pharmaceutical products and ensure compliance with cleanliness standards.
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Injectables

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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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