QMS-195 Retention Sample Management

 1. Purpose

This procedure describes the collection, storage, and management of retention samples at a GMP site. 

 2. Scope

This procedure applies to biological and pharmaceutical products; raw materials used in the manufacturing processes; Third party manufactured products Purchased products; Packaging and Components.

 3. Responsibilities

QA Associate(s) is responsible for the maintenance of the retention sample program, the disposal of expired retention samples and the collection of raw material, packaging retention samples, Third party and Purchased Finished product retention samples.

Production Line Supervisors/Team Leaders are responsible for the collection and labeling of retention samples of products manufactured at the Penrith and Crookwell facilities.

 4. General

The retention sample system is divided into separate areas, with specific procedures outlined in this SOP. It is the QA Departments’ responsibility to oversee the program, with the assistance of the Production Areas Supervisors. 

Retention samples need to be stored under the registered storage conditions with access to these samples by QA only. Once a sample has reached the allocated destruction date, it must be disposed of appropriately.

Retention sample storage areas are described in Table 1.

Retention sample sizes are described in Table 2.

Retention sample logs are maintained for each area and type.

In the event of a product complaint, or if further investigation/testing is required, the retention sample is located, removed and tested. Any removal is documented on the appropriate log.

When retention samples are transferred to an external warehouse, the details are recorded in the appropriate log.

‘Drop boxes’ have been set up in certain locations where the line supervisors are to leave the retention samples collected during a packing job. Once notified that the samples have been collected, the QA Associate will retrieve the samples and proceed as per this procedure.

Retention logs are to remain with QA until ALL items recorded in the log have reached the destruction date, been disposed of and the date of disposal recorded. Once a log book is complete, it is forwarded to Documentation for archiving.

 5. Safety and Process Specific Information

All safety requirements for relevant areas at the GMP facilities must be followed at all times.

 6. Pharmaceutical Finished Products 

During each packing job, the Production Supervisor (or delegate) retains 1 sample of the finished, filled product. A photograph of all the packaging items is taken as a record of the appearance of the finished product but only the labeled, filled container is retained, due to the size of the outer packaging of some product lines.

Each container is labeled with an in-house printed retention label.

The QA Associate is notified that the sample is ready for collection and checks that the details are correct. 

The sample/s are then placed in the appropriate storage area on a designated pallet, refer to Table 1, and the details recorded on the Retention Sample Log (Form-965), 

Once a pallet is full, it shall be black shrink wrapped and sent to the warehouse for long term storage. QA shall notify the warehouse that the pallet is to be relocated for off-site storage. The details shall be recorded on the appropriate Retention Sample Log.

Destruction date is 1 year past expiry date.

 7. Biological and Sterile Pharmaceutical Finished Products

The first and last fully finished samples are collected by the Packing Team Leader or delegate and labeled with an in-house label.

For 2 – 8°C retention samples, these are placed in the drop box located in the cold room.

The QA Associate is notified that the samples are ready for collection. The details of the samples are checked. 

The samples are then transferred to the appropriate storage area; refer to Table 1, and the details recorded on the Retention Sample Log (Form-965 or Form-975), 

Destruction date is 1 year past expiry date.

 8. Biological Filled Product (For EU Market)

As each sterility sample is collected on the fill line, the following 2 samples are collected and labeled as retention samples (e.g. 10 sterility samples taken and 20 retention samples taken).

On completion of each fill day the QA Associate is notified the samples are ready for collection and checks the details are correct.

The samples are then placed in the appropriate storage area; refer to Table 1, and the details recorded on the Retention Sample Log (Form-975), 

Destruction date is 1 year past expiry date.

 9. Purchased Fully Finished Product/ Third Party Manufactured Product

For product that is purchased or manufactured by the third partyies and delivered to warehouse, samples are removed from the delivery by QA or an appropriately trained warehouse operator once the QIS or delivery documents have been received and the number taken recorded on the QIS (Refer to Table 2).

Warehouse staff will complete the ‘request for samples’ form and forward to the warehouse. Refer to Table 2 for retention sample requirements. The warehouse operators will retrieve the requested number of samples and forward to the QA Associate and make the necessary stock adjustments.

QA checks that the details are correct. 

The samples are then placed in the appropriate storage area; refer to Table 1, and the details recorded on the appropriate Retention Sample Log (Form-965 or Form-975). 

QA staff records the storage location of the samples according to destruction date (month / year) on Form-995.

Destruction date is 1 year past the allocated expiry date.

Semi – Finished Products

Retention Samples may not be required for Semi-Finished Purchased product; the sample will be taken once the final packing is complete. Refer to the relevant Finished Product Specification for requirements.

Destruction date is 1 year past expiry date.

 10. Secondary Packed Finished Products

Retention Samples are taken as per the relevant packing paperwork and labeled with an in-house label.

The samples are placed in the relevant ‘drop box’ and the QA Associate notified that the samples are ready for collection. 

The QA Associate checks that the details are correct. 

The samples are then placed in the appropriate storage area; refer to Table 1, and the details recorded on the Retention Sample Log (Form-965 or Form-975), 

Destruction date is 1 year past expiry date.

 11. Antigens

Upon containment of antigen into a mobile vessel, a production technician takes 2 x 500mL samples of that antigen and labels with the relevant information:

The details are recorded in the Production Sample log Form 1000, by the production technician and the sample and log forwarded to a QA Associate. QA checks that the sample details and appearance are correct and signs the production log to confirm that the samples have been received.

The samples are then placed in the box labeled for the year the antigen is to be destroyed in the appropriate storage location, refer to Table 1, and the details recorded on the Retention Sample Log (Form 970).

Destruction date of antigen samples is 5 years from date of containment. (Maximum shelf life of any antigen produced is typically 36 months. Antigens are kept ≥ 2 years past their shelf life).

Registered Secondary Packaging (For EU Market)

Retention samples are retained from every delivery of registered secondary packaging used to package European product. The sample may be taken from the ‘Inspection’ samples provided that no destructive testing has been conducted (refer to QMS-190 Inspection, Sampling and Disposition of Incoming Goods). 

Each sample is labeled with the blue ‘Retention’ label, as per WAR-095 Status Labels, with the ‘QIS number’; QA Associate shall sign and date the label. 

The sample/s are then placed in the appropriate storage location, refer to table 1 and the details recorded in the Packaging Retention Sample Log (Form-990) 

Destruction date is 3 years past the allocated expiry date. 

Labels/ Instruction Leaflets

Retention samples are retained from every delivery (refer to Table 2) and are attached to the QIS once dispositioned. These will remain with the QIS in the relevant folder.

 12. Primary Components

A sample is to be retained from every delivery (refer to Table 2). This applies to containers, caps, taps and dosing guns (excluding non-printed pails and lids). The sample may be taken from the ‘Inspection’ samples (refer to QMS-190 Inspection, Sampling and Disposition of Incoming Goods) provided that no destructive testing has been conducted. 

Each component is to be labeled using the blue ‘Retention’ label, as per WAR-095 Status Labels, with the ‘QIS number’. QA Associate shall sign and date the label. 

For samples that the label will not adhere to, attach the label to a grip-lock bag and place the component inside the bag. Samples are then stored in the appropriate location, refer to Table 1and the details recorded in the Component retention Sample Log (Form-985).

Destruction date is 3 years past the allocated expiry date. 

 13. Raw Materials

Retention samples shall be taken from raw material deliveries as outlined in the Raw Material Sampling SOP, WAR-045 Sampling of Raw Materials; relevant raw material specification and Table 2 of this SOP.

Samples are stored as per Table 1.

The sample/s are then placed in the appropriate storage location, refer to Table 1 and the details recorded in the Raw Material Retention Sample Log (Form-980) 

Destruction date is 5 years from date of expiry.

 14. Disposal

QA will review the logs on a 12 month basis. A list of all product and raw material retention samples that are due for destruction is to be prepared containing the Product name, pack size, no. of packs and current location of the samples and forwarded to the EHS Specialist who will then organize the appropriate pick up and disposal arrangements. Once destruction is confirmed, the destruction date is documented on the appropriate retention sample log.

Biological Filled and Fully Finished samples that are due for destruction may be removed from the packaging and placed into an appropriately labeled container until destruction by incineration can be arranged. The packaging and components may be placed in the recycling bins provided that they have been defaced and have not had product contact, otherwise they shall be destroyed by incineration. 

Raw Material samples for destruction are placed in an appropriately labeled container until destruction can be arranged.

Antigen retention samples that are due for destruction are placed in the small ‘for incineration bins’ once the clamps have been removed. The clamps are forwarded to Media prep for autoclaving and re-use.

Pharmaceutical Retention Samples are to be clearly identified as ‘for disposal’.

Printed cardboard packaging retention samples may be placed in the compactor, provided they have been defaced and have not had any product contact, otherwise they shall be destroyed by incineration.

Primary Components retention samples should be placed in the general waste bins provided they have not had any product contact, otherwise they shall be destroyed by incineration.

Table 1 – Storage Areas

Table 2 – Retention Sample Requirements