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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:

Capsule Formulation: Capsule Formulation: SOP for Disintegration Testing

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The purpose of this SOP is to provide guidelines for performing disintegration tests to determine how quickly capsules disintegrate in a specified liquid medium.
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Capsule Formulation

SOP for Actions to Be Taken if Content Uniformity is Out of Specification

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The purpose of this SOP is to outline the actions to be taken when content uniformity of capsules is found to be out of specification, including documentation and investigation procedures.
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Capsule Formulation

SOP for Criteria for Determining Acceptable Content Uniformity

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The purpose of this SOP is to establish criteria for determining acceptable content uniformity in capsules to ensure the even distribution of the active ingredient.
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Capsule Formulation

SOP for Sampling Procedures for Content Uniformity Tests

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The purpose of this SOP is to outline the sampling procedures for selecting capsules for content uniformity tests to ensure a representative and unbiased sample.
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Capsule Formulation

Capsule Formulation: SOP for Content Uniformity Testing

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The purpose of this SOP is to provide guidelines for conducting content uniformity tests to ensure that the active ingredient is evenly distributed among capsules.
Click to read the full article.

Capsule Formulation

SOP for Actions to Be Taken if Weight Variation Exceeds Acceptable Limits

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The purpose of this SOP is to outline the actions to be taken when the weight variation of filled capsules exceeds acceptable limits, including documentation and investigation procedures.
Click to read the full article.

Capsule Formulation

SOP for Criteria for Determining Acceptable Weight Variation

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The purpose of this SOP is to establish criteria for determining acceptable weight variation in filled capsules to ensure uniformity and quality in the final product.
Click to read the full article.

Capsule Formulation

SOP for Weight Variation Control

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The purpose of this SOP is to establish a procedure for periodically checking the weight of filled capsules to ensure consistency within specified limits and maintain product quality.
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Capsule Formulation

SOP for Raw Material Release

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The purpose of this SOP is to establish procedures for inspecting and releasing raw materials for use in manufacturing based on predefined criteria to ensure quality and compliance.
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Capsule Formulation

SOP for Resampling and Retesting

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The purpose of this SOP is to provide clear guidelines for resampling and retesting materials or products when initial results are questionable or invalidated to ensure the accuracy and reliability of test results.
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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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