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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 Emergency Response and Evacuation: Instructions for Handling Emergencies, Including Evacuation Procedures, Contact Information, and Emergency Equipment Locations

Posted on By

The purpose of this Standard Operating Procedure (SOP) is to provide instructions for handling emergencies, including evacuation procedures, contact information, and emergency equipment locations within the pharmaceutical manufacturing facility.
Click to read the full article.

Capsule Formulation

SOP for Training and Competency: Requirements for Training Employees, Maintaining Training Records, and Assessing Competency in Various Manufacturing Tasks

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The purpose of this Standard Operating Procedure (SOP) is to establish the requirements for training employees, maintaining training records, and assessing competency in various manufacturing tasks within the pharmaceutical industry.
Click to read the full article.

Capsule Formulation

SOP for Handling of Deviations and Incidents: Procedures for Identifying, Documenting, and Investigating Deviations, Incidents, or Non-conformances in the Manufacturing Process

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The purpose of this Standard Operating Procedure (SOP) is to establish procedures for identifying, documenting, and investigating deviations, incidents, or non-conformances that occur during the manufacturing process in the pharmaceutical industry.
Click to read the full article.

Capsule Formulation

SOP for Out of Specification (OOS) Investigations: Steps for Investigating and Addressing Test Results that Fall Outside Established Specifications

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The purpose of this Standard Operating Procedure (SOP) is to define the steps for investigating and addressing test results that fall outside established specifications (Out of Specification or OOS results) in the pharmaceutical industry.
Click to read the full article.

Capsule Formulation

SOP for Quality Assurance and Quality Control (QA/QC) Communication: Guidelines for Communication Between QA and QC Departments, Including Reporting of Deviations and Investigations

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The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for effective communication between the Quality Assurance (QA) and Quality Control (QC) departments to ensure timely reporting, investigation, and resolution of deviations and quality issues.
Click to read the full article.

Capsule Formulation

SOP for Batch Release and Product Disposition: Procedures for Reviewing and Releasing Finished Batches for Distribution and Ensuring Product Disposition

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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for reviewing and releasing finished batches of products for distribution, and ensuring proper product disposition to comply with regulatory requirements and maintain product quality.
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Capsule Formulation

SOP for Reconciliation of Materials: Steps to Reconcile the Quantities of Raw Materials Used with What Was Planned and What Remains After Production

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The purpose of this Standard Operating Procedure (SOP) is to outline the steps required to reconcile the quantities of raw materials used in production with the planned quantities and the remaining inventory to ensure accurate inventory management and compliance with regulatory requirements.
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Capsule Formulation

SOP for Material Handling and Storage: Guidelines for the Proper Handling, Storage, and Labelling of Raw Materials and Intermediates

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The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper handling, storage, and labelling of raw materials and intermediates to prevent contamination, mix-ups, and ensure product quality and safety.
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Capsule Formulation

SOP for Change Control Procedures: Procedures for Requesting, Evaluating, and Implementing Changes to Equipment, Processes, or Materials

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The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for requesting, evaluating, approving, and implementing changes to equipment, processes, or materials to ensure that all changes are properly controlled and documented in compliance with regulatory requirements.
Click to read the full article.

Capsule Formulation

SOP for Equipment Calibration and Maintenance: Procedures for Regular Calibration and Maintenance of Equipment

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The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the regular calibration and maintenance of equipment used in pharmaceutical manufacturing to ensure accuracy, reliability, and compliance with regulatory standards.
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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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