personnel involved in stability testing, including scientists, researchers, and regulatory affairs professionals.

3) Responsibilities

The responsibilities for designing a stability study protocol are as follows:

• R&D Team: To develop the stability study protocol according to the requirements and specifications of the product.
• Quality
  

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  Control Team: To review the protocol to ensure it meets the necessary guidelines and quality standards.
• Regulatory Affairs Team: To ensure that the protocol is compliant with the relevant regulatory requirements.
• Stability Study Coordinator: To approve the final protocol and ensure it is implemented correctly during the stability studies.

4) Procedure

The detailed stepwise procedure for designing a stability study protocol for drug products is outlined below:

1. Protocol Development:
1. 4.1 Identify the purpose of the stability study (e.g., determination of shelf life, regulatory submission, etc.).
2. 4.2 Define the scope of the study, including the type of product, dosage form, and packaging configuration.
3. 4.3 Determine the critical quality attributes (CQAs) that will be monitored during the study, such as potency, purity, and dissolution rate.
4. 4.4 Establish the storage conditions for the study as per ICH guidelines (e.g., long-term, intermediate, and accelerated conditions).
5. 4.5 Specify the time points at which samples will be collected and tested (e.g., 0, 3, 6, 9, 12, 18, 24 months).
2. Sample Selection and Preparation:
1. 4.6 Choose representative samples from different batches to be tested under the stability study protocol.
2. 4.7 Prepare the samples in the final packaging configuration to simulate real-life storage conditions.
3. 4.8 Ensure all samples are appropriately labeled with necessary details, including batch number, storage conditions, and time points.
3. Documentation of Protocol:
1. 4.9 Document the protocol in a standardized format, including the objectives, scope, test methods, acceptance criteria, and data interpretation guidelines.
2. 4.10 Ensure the protocol includes a clear definition of the study’s parameters, such as storage conditions, frequency of testing, and methods for analyzing results.
3. 4.11 Review and approve the protocol by the designated authorities (e.g., Quality Control, R&D, and Regulatory Affairs teams).
4. Compliance with Regulatory Requirements:
1. 4.12 Verify that the protocol complies with relevant regulatory guidelines (e.g., ICH Q1A, Q1B, etc.) and internal quality standards.
2. 4.13 Make any necessary adjustments to the protocol based on feedback from the reviewing teams or regulatory agencies.
5. Protocol Implementation and Review:
1. 4.14 Distribute the finalized protocol to all relevant personnel involved in the stability study.
2. 4.15 Ensure all team members understand the protocol and their roles in its implementation.
3. 4.16 Conduct a review meeting to discuss the protocol details and address any questions or concerns.
6. Archival and Future Use:
1. 4.17 Archive the approved stability study protocol in a controlled document management system.
2. 4.18 Use the protocol as a reference for future stability studies of similar products.

5) Abbreviations, if any

• CQA: Critical Quality Attribute
• ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

6) Documents, if any

• Stability Study Protocol Template
• Stability Testing Log Sheets
• Regulatory Compliance Checklists

7) Reference, if any

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• ICH Q1B: Photostability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0