Standard Operating Procedure for Formulating Nutraceutical Capsules

Department	Capsule Manufacturing
SOP No.	SOP/CM/050/2025
Supersedes	SOP/CM/050/2022
Page No.	Page 1 of 7
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to define the procedures for formulating nutraceutical capsules. This includes guidelines for selecting raw materials, formulation design, manufacturing processes, and quality control to ensure the final product is safe, effective, and compliant with regulatory requirements.

2. Scope

This SOP applies to the formulation and manufacturing of nutraceutical capsules. It covers the selection of active ingredients, excipients, and the manufacturing processes, including encapsulation, coating, and testing to ensure the capsules meet the desired specifications for efficacy, safety, and quality.

3. Responsibilities

• Formulation Development Team: Responsible for designing the nutraceutical capsule formulation, selecting appropriate active ingredients and excipients, and ensuring that the formulation meets regulatory requirements.
• Manufacturing Team: Responsible for producing the nutraceutical capsules according to the formulated recipe, ensuring the correct process parameters are followed and documenting the process.
• Quality Control (QC) Team: Responsible for conducting physical, chemical, and microbiological testing of the nutraceutical capsules to ensure they meet required specifications, including content uniformity and dissolution.
• Quality Assurance (QA) Team: Ensures that the formulation, manufacturing, and testing processes comply with GMP standards and regulatory guidelines. Reviews all relevant documentation to ensure product quality.
• Regulatory Affairs Team: Ensures that the formulation complies with regulatory requirements for nutraceutical products and that all necessary documentation for regulatory submissions is prepared and submitted.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring the correct execution of this SOP. The QA Manager is responsible for ensuring that all regulatory compliance and quality control requirements are met during the formulation and manufacturing processes.

5. Procedure

5.1 Selection of Active Ingredients and Excipients

The first step in formulating nutraceutical capsules is to select the appropriate active ingredients and excipients:

1. Active Ingredients
   1. Choose active ingredients based on their therapeutic benefits, safety profile, and efficacy. Ensure that the active ingredients are approved for use in nutraceutical formulations.
   2. Ensure that the active ingredient dosage is appropriate for the intended health benefit and target population.
2. Excipients
   1. Choose excipients that are safe, inert, and compatible with the active ingredient. Common excipients include binders, fillers, lubricants, and disintegrants.
   2. Ensure that the excipients do not affect the bioavailability or stability of the active ingredients.

5.2 Formulation Development

Once the ingredients have been selected, proceed with the formulation development:

1. Formulation Design
   1. Determine the appropriate dosage form (e.g., capsule size, composition) based on the active ingredient properties and intended use.
   2. Ensure that the capsule size is suitable for containing the required dosage of the active ingredient, with appropriate excipient quantities to ensure stability and ease of manufacture.
2. Preformulation Studies
   1. Conduct preformulation studies to assess the solubility, stability, and compatibility of the active ingredients and excipients.
   2. Perform compatibility testing to ensure that the active ingredients and excipients do not interact negatively during storage or production.
3. Prototype Formulation
   1. Prepare prototype formulations and evaluate their performance in terms of dissolution, bioavailability, and physical stability.
   2. Make necessary adjustments to the formulation to optimize capsule performance and stability.

5.3 Manufacturing Process

Once the formulation is finalized, proceed with the manufacturing process:

1. Capsule Filling
   1. Prepare the capsule filling by blending the active ingredient with excipients according to the approved formulation recipe.
   2. Ensure that the capsule filling process is performed under controlled conditions to maintain product uniformity and prevent contamination.
2. Encapsulation
   1. Fill the prepared blend into capsules using the encapsulation machine. Ensure that the capsules are filled to the required weight and that no overfilling or underfilling occurs.
   2. Perform checks on capsule integrity, weight, and uniformity at regular intervals during the encapsulation process.
3. Coating (If Applicable)
   1. If required, apply a coating to the capsules to improve stability, protect against environmental factors (e.g., light, moisture), or control the release of the active ingredient.

5.4 Quality Control Testing

During and after the manufacturing process, the following quality control tests should be performed:

1. Physical Testing
   1. Test capsules for physical attributes, including size, shape, hardness, and color.
   2. Perform weight uniformity tests to ensure consistent dose delivery in each capsule.
2. Chemical Testing
   1. Perform dissolution tests to ensure that the capsule dissolves as intended in the body.
   2. Conduct content uniformity tests to ensure each capsule contains the correct amount of the active ingredient.
3. Microbiological Testing
   1. Test for microbial contamination to ensure that the capsules are safe for consumption and meet regulatory standards for microbial limits.

5.5 Packaging and Labeling

Once the capsules pass all quality control tests, proceed with packaging and labeling:

1. Packaging
   1. Package the capsules in appropriate containers (e.g., blister packs, bottles) that protect the product from environmental factors such as moisture, light, and air.
   2. Ensure that packaging materials are suitable for nutraceutical products and comply with regulatory standards.
2. Labeling
   1. Label the product with the necessary information, including dosage, active ingredients, directions for use, warnings, and storage conditions.
   2. Ensure that the label complies with the relevant regulations, including health claims and ingredient disclosures.

5.6 Documentation and Record-Keeping

It is essential to document every step of the formulation and manufacturing process:

1. Batch Records
   1. Maintain detailed batch records for each manufacturing run, including raw material lot numbers, manufacturing dates, process parameters, and testing results.
2. Quality Control Records
   1. Maintain records of all quality control tests, including physical, chemical, and microbiological testing data, and compare them to the specified acceptance criteria.
3. Regulatory Compliance Records
   1. Ensure that all documentation is in compliance with regulatory requirements and is stored in a secure and accessible manner for audits and inspections.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• GMP: Good Manufacturing Practice
• HPLC: High-Performance Liquid Chromatography

7. Documents

1. Formulation Record (Annexure-1)
2. Batch Record (Annexure-2)
3. Quality Control Testing Report (Annexure-3)
4. Packaging and Labeling Record (Annexure-4)

8. References

• FDA Guidelines for Nutraceutical Products
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Development
• EMA Guidelines for the Manufacture of Nutraceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Formulation Record

Formulation ID	Active Ingredient	Excipients
FR-001	Vitamin C	Magnesium Stearate, Lactose

Annexure-2: Batch Record

Batch ID	Manufacturing Date	Process Parameters
Batch 001	01/02/2025	Speed: 120 rpm, Temperature: 25°C

Annexure-3: Quality Control Testing Report

Test Type	Result	Specification	Remarks
Dissolution	Pass	Release in 30 minutes	Meets Specifications

Annexure-4: Packaging and Labeling Record

Packaging Type	Labeling Information
Blister Pack	Contains 30 Capsules, Store in a Cool, Dry Place

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated formulation processes	Standardization	QA Head