Standard Operating Procedure for Retention Samples Handling in Ointment Formulation

1) Purpose

The purpose of this SOP is to define the procedures for handling retention samples of ointments to ensure compliance with regulatory requirements and facilitate future quality evaluations.

2) Scope

This SOP applies to all personnel involved in the collection, storage, and management of retention samples in the ointment formulation process.

3) Responsibilities

– Production Staff: Responsible for collecting and labeling retention samples.
– Quality Assurance (QA): Responsible for overseeing the retention sample process and ensuring compliance with regulations.
– Warehouse Staff: Responsible for the proper storage and inventory of retention samples.

4) Procedure

1. Collection of Retention Samples:
1.1 Sample Collection:
1.1.1 Collect retention samples from each batch of ointment.
1.1.2 Ensure samples are representative of the entire batch.
1.2 Labeling:
1.2.1 Label each sample with the batch number, date of manufacture, and expiration date.
1.2.2 Include additional information as required by regulatory guidelines.

Storage of Retention Samples:
2.1 Storage Conditions:
2.1.1 Store samples in designated, secure areas.
2.1.2 Maintain storage conditions as specified for the product (e.g., temperature, humidity).

2.2 Inventory Management:
2.2.1 Maintain an inventory log of all retention samples.
2.2.2 Conduct regular inventory checks to ensure sample integrity and availability.

Review and Testing:
3.1 Periodic Review:
3.1.1 Periodically review retention samples for any signs of degradation.
3.1.2 Document findings and take corrective actions if necessary.

3.2 Regulatory Testing:
3.2.1 Use retention samples for regulatory testing or investigation as required.
3.2.2 Document all testing activities and results.

Disposal of Retention Samples:
4.1 Disposal Procedures:
4.1.1 Dispose of samples after the retention period has expired, according to regulatory guidelines.
4.1.2 Document the disposal process, including batch numbers and disposal dates.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Retention Sample Log
– Inventory Records
– Testing Reports

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– WHO Guide to Good Manufacturing Practice (GMP) Requirements

8) SOP Version

Version 1.0