Standard Operating Procedure for Handling of Excipients and Active Pharmaceutical Ingredients (APIs) in Ointment Formulation

1) Purpose

The purpose of this SOP is to establish procedures for the handling of excipients and active pharmaceutical ingredients (APIs) in ointment formulation to ensure their quality, safety, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the receipt, storage, dispensing, and use of excipients and APIs in the ointment formulation process.

3) Responsibilities

– Production Staff: Responsible for handling excipients and APIs according to established procedures.
– Quality Assurance (QA): Responsible for auditing and ensuring compliance with SOPs.
– Warehouse Staff: Responsible for the receipt, storage, and inventory management of excipients and APIs.

4) Procedure

1. Receipt and Acceptance:
1.1 Receipt Inspection:
1.1.1 Inspect incoming excipients and APIs for integrity, labeling accuracy, and compliance with specifications.
1.1.2 Reject any materials that do not meet acceptance criteria.

1.2 Documentation:
1.2.1 Document receipt of excipients and APIs, including batch numbers, quantities received, and supplier information.
1.2.2 Maintain supplier qualification records and certificates of analysis.

2. Storage and Handling:
2.1 Storage Conditions:
2.1.1 Store excipients and APIs in designated areas according to labeled storage conditions (e.g., temperature, humidity).
2.1.2 Monitor storage conditions and perform temperature/humidity mapping as necessary.

2.2 Segregation:
2.2.1 Segregate different excipients and APIs to prevent cross-contamination.
2.2.2 Use dedicated storage areas for high-risk materials (e.g., allergens, potent compounds).

3. Dispensing and Use:
3.1 Dispensing Procedures:
3.1.1 Use calibrated dispensing equipment to accurately measure excipients and APIs.
3.1.2 Perform dispensing activities in designated areas following hygiene and safety protocols.

3.2 Labeling:
3.2.1 Label containers with necessary information, including product name, batch number, and expiration date.
3.2.2 Ensure labels are clear, legible, and resistant to smudging or fading.

4. Documentation and Recordkeeping:
4.1 Batch Records:
4.1.1 Document all activities related to the handling, dispensing, and use of excipients and APIs in batch records.
4.1.2 Include details such as quantities used, batch numbers, and equipment used.

4.2 Inventory Management:
4.2.1 Maintain accurate inventory records of excipients and APIs.
4.2.2 Conduct regular reconciliations of physical inventory with electronic records.

5. Quality Control Checks:
5.1 Sampling and Testing:
5.1.1 Perform sampling and testing of incoming excipients and APIs as per approved procedures.
5.1.2 Retain samples for further testing or investigations as necessary.

5.2 Release Procedures:
5.2.1 Release excipients and APIs for use only after passing all quality control tests and inspections.
5.2.2 Document release activities and approvals.

6. Waste Disposal:
6.1 Segregation and Disposal:
6.1.1 Segregate waste materials (e.g., expired, damaged) from usable stock.
6.1.2 Dispose of waste according to regulatory requirements and environmental guidelines.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– API: Active Pharmaceutical Ingredient

6) Documents, if any

– Receipt Records
– Batch Records
– Inventory Logs
– Testing Reports

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0