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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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  • Job Safety Analysis (JSA)
    • Oral Dosage Forms (Tablets & Capsules)
    • Oral Liquid Dosage Forms (Syrups, Elixirs, Suspensions, Emulsions)
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    • Topical Dosage Forms (Creams, Ointments, Gels, Lotions, Pastes)
    • Transdermal Dosage Forms (Patches)
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SOPs for Rectal Dosage Forms

SOP for Validation of Processes

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The purpose of this SOP is to establish procedures for the validation of processes, including equipment, systems, and methods, to ensure consistency, reliability, and compliance with regulatory requirements.
Click to read the full article.

Rectal Dosage Forms

SOP for Handling of Deviations

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The purpose of this SOP is to establish procedures for handling and investigating deviations from established processes, procedures, and specifications to ensure product quality and compliance.
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Rectal Dosage Forms

Rectal Dosage Forms: SOP for Calibration of Equipment

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The purpose of this SOP is to establish procedures for the calibration of equipment used in the manufacturing process to ensure accuracy, reliability, and compliance with regulatory requirements.
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Rectal Dosage Forms

Rectal Dosage Forms: SOP for Internal Audits

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The purpose of this SOP is to establish a procedure for conducting internal audits to ensure compliance with regulatory requirements, internal policies, and quality standards.
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Rectal Dosage Forms

Rectal Dosage Forms: SOP for Training and Competency

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The purpose of this SOP is to establish a procedure for training and assessing the competency of personnel to ensure they have the necessary knowledge and skills to perform their duties effectively and comply with regulatory requirements.
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Rectal Dosage Forms

Rectal Dosage Forms: SOP for Risk Management

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The purpose of this SOP is to establish a procedure for the identification, assessment, and management of risks to ensure the quality and safety of pharmaceutical products.
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Rectal Dosage Forms

Rectal Dosage Forms: SOP for Environmental Monitoring

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The purpose of this SOP is to establish procedures for the monitoring of environmental conditions within the manufacturing facility to ensure compliance with regulatory requirements and to maintain product quality.
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Rectal Dosage Forms

SOP for Cleaning and Sanitation

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The purpose of this SOP is to establish procedures for the cleaning and sanitation of the manufacturing facility and equipment to ensure a hygienic environment and prevent contamination of pharmaceutical products.
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Rectal Dosage Forms

Rectal Dosage Forms: SOP for Handling Customer Complaints

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The purpose of this SOP is to establish a procedure for the effective handling of customer complaints to ensure timely resolution and continuous improvement of product quality and customer satisfaction.
Click to read the full article.

Rectal Dosage Forms

Rectal Dosage Forms: SOP for Change Control Management

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The purpose of this SOP is to establish a procedure for managing changes to processes, procedures, equipment, and systems to ensure continued compliance with regulatory requirements and quality standards.
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Rectal Dosage Forms

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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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