SOP for Collection and Storage of Retention Sample of Raw Material

PURPOSE

To describe methods for retaining reserve samples of appropriate lots of products and related materials.

SCOPE

• This procedure describes methods for obtaining, identifying, storing, and documenting appropriate information as it applies to retention samples from each lot.
• This procedure applies to retention samples of finished goods and certain subassemblies.
• This procedure applies to retention samples of chemical and other raw materials received for use in products and subassemblies.

RESPONSIBILITY

• It is the responsibility of Quality Control personnel to obtain, identify, maintain appropriate documentation, and appropriately store retention samples.
• It is the responsibility of Manufacturing personnel to provide enough manufactured material so that appropriate retention samples can be obtained by Quality Control.
• It is the responsibility of Quality Control to document the disposition of any retention samples removed from storage for various uses.

ACCOUNTABILITY

Head of the Department

PROCEDURAL PRINCIPLES AND INTRODUCTION

• Retention samples are not required for every raw material and manufactured part and are specified in PNS’s.

1. Retention samples are required of all final assemblies.

• If a reserve sample must be retained, it will be specified in the appropriate PNS document.

1. PNS will specify an amount to be retained, storage containers and conditions required, and other important information about the retention sample requirements.

• The retention sample must be retained for a minimum of 1 year after the expiration date of the material.
• Retention samples of aseptically filled products must be kept in their original product container (vial).

1. For other sterile products or raw materials, retention samples of the sterile unopened product must be kept.

• Retention samples must be representative of the lot.
• Retention samples of final kit assemblies must contain all the components of the kit but do not have to be retained in the final packaging box or other assemblies.
• Assemblies or other parts with cosmetic defects that do not affect the integrity of the part may be kept as retention samples.
• Individual retention samples and outer containers must be appropriately and adequately identified as QC retention samples. They must be segregated from samples in quarantine or other QC status.

• Retention sample outer containers should be adequately identified so that specific samples can be easily retrieved from storage at a later date.
• Each manufactured or purchased part number must have a separate log sheet; multiple lots of the same part number must be recorded on the same sheet.

ALSO READ: SOP for Analyst Validation

PROCEDURE

• Collect the required quantity of retained samples from the raw material received.
• Take the sample in plain & black Polybags (In case if light-sensitive material).
• Keep this bag in an airtight plastic container.
• Place the label on the plastic container having the following Details.

RETAIN SAMPLE

1. NAME OF Material: _________________
2. BATCH NO: ______________________
3. QUANTITY: _______________________
4. DATE: __________________________              
5. A.R. No.:_______________________

• Enter the data in the ‘Retain sample register’ as per the following details.

1. Sr. No.:
2. A.R. No.:
3. Name of Raw Material :
4. Batch No.:
5. Qty Sampled :
6. Date of preparation :
7. Storage condition :
8. Box No.:
9. Sign :

• Keep the plastic container in the box number as specified in the register.
• Store the retained sample container for 10 years as per the list of storage conditions available in the Q.C. Dept.
• Destroy the retained samples after 10 years.
• Prepare the list of RM to be destroyed and get approval for the same.
• For the destruction of retained samples soak the material in water or collect the liquid material& drain by flushing with excess water.
• Transfer the empty bottles, and containers to the scrap area as per Ref. S.O.P.
• Preserve the destruction record for 5 years after the date on which they are destroyed.

ABBREVIATION

A.R.No.: Analytical Report number

Sr. No.: Serial number

Qty: Quantity

Q.C.: Quality Control

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Safety Guideline in QC Laboratory