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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Capsule Formulation

Capsule formulation represents a versatile and widely utilized method in pharmaceutical manufacturing, offering a convenient and efficient means of delivering medications to patients. Capsules consist of a shell, typically made from gelatin or vegetarian alternatives, containing powdered or liquid medication. The formulation process involves carefully blending active pharmaceutical ingredients (APIs) with suitable excipients to achieve desired properties such as stability, solubility, and bioavailability. Capsule formulations can accommodate a wide range of drug types, including solids, liquids, and semi-solids, making them adaptable to various therapeutic needs. Additionally, capsules offer advantages such as ease of swallowing, accurate dosing, and protection of sensitive ingredients from degradation. The flexibility in capsule sizes and compositions enables pharmaceutical companies to tailor formulations to specific patient requirements and preferences. Overall, capsule formulation remains a cornerstone of modern pharmaceuticals, providing effective and patient-friendly delivery systems for a diverse array of medications.

List of SOPs for Capsule Formulations are as follows:

SOP for Sifting and Sieving: Guidelines for Operating Sifters and Sieves, Including Particle Size Analysis and Documentation

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating sifters and sieves, including guidelines for particle size analysis and documentation, to ensure consistent particle size distribution.
Click to read the full article.

Capsule Formulation

SOP for Using Drying Ovens: Including Temperature, Time, and Humidity Control

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating drying ovens, including temperature, time, and humidity control, to ensure proper drying of pharmaceutical products.
Click to read the full article.

Capsule Formulation

SOP for Operation of Tablet Press: Including Tooling Setup and Tablet Compression

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for setting up and operating a tablet press, including tooling setup and tablet compression, to ensure consistent and high-quality tablet production.
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Capsule Formulation

SOP for Capsule Polishing: Detailed Procedure for Operating Capsule Polishing Machines

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating capsule polishing machines, including setup, cleaning, and maintenance, to ensure that capsules are polished and free of excess powder and debris.
Click to read the full article.

Capsule Formulation

SOP for Capsule Sorting: Detailed Procedure for Sorting Capsules by Size, Color, and Defects

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for sorting capsules by size, color, and defects to ensure product uniformity and quality.
Click to read the full article.

Capsule Formulation

Capsule Formulation: SOP for Capsule Polishing: Detailed Procedure for Operating Capsule Polishing Machines

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating capsule polishing machines, including setup, cleaning, and maintenance, to ensure that capsules are polished and free of excess powder and debris.
Click to read the full article.

Capsule Formulation

SOP for Capsule Filling: Detailed Steps for Operating Capsule Filling Machines

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating capsule filling machines, including setup, cleaning, filling, and troubleshooting, to ensure consistent and accurate filling of capsules.
Click to read the full article.

Capsule Formulation

SOP for Capsule Inspection: Instructions for Inspecting Filled Capsules, Identifying Defects, and Documenting Results

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for inspecting filled capsules, identifying defects, and documenting results to ensure product quality and compliance with regulatory standards.
Click to read the full article.

Capsule Formulation

SOP for Granulation Process: Equipment Setup, Process Parameters, and Batch Documentation

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The purpose of this Standard Operating Procedure (SOP) is to provide detailed guidelines for the granulation process, including equipment setup, process parameters, and batch documentation, to ensure uniform granules in pharmaceutical production.
Click to read the full article.

Capsule Formulation

SOP for Mixing and Blending: Procedures for Uniform Blending of Ingredients in Mixers

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The purpose of this Standard Operating Procedure (SOP) is to ensure the uniform blending of ingredients in mixers to produce consistent and high-quality pharmaceutical products.
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Capsule Formulation

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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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