| Department | Laboratory | Document no | LAB-045 | ||
| Title | Retention Samples – Laboratory | ||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Document Owner
Laboratory Manager
Affected Parties
All Laboratory/QA staffs
Purpose
The purpose of this SOP is to describe the procedure for the retention of Finished Good and Raw Material, products manufactured and/or received onsite, and/or chemically tested by the Laboratory.
Scope
This SOP is to be followed by the Laboratory staffs assigned to retention Samples in the execution of the collection, storage preparation, transportation, storage and disposal of retention Samples.
This SOP is also to be followed by Quality Assurance staffs, who are responsible for checking and storing retention samples in the retention Sample Room.
Only the person delegated by the QA / Laboratory Manager is allowed to retrieve retention Samples from the retention sample room.
Definition
Retention Samples | A sample from every batch of product made and the chemicals and components that make up a finished good are kept for a set period of time for use as reference material should there be a problem with a specific product or batch.
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– The retention sample shall consist of at least twice the quantity necessary for all tests required to determine its compliance with specification.
– The retention sample shall be stored in controlled room temperature except where the product labelling and/or specification states otherwise.
– The retention sample shall be stored in the same primary container enclosure system in which the product is marketed or shipped, or in one that has essentially the same characteristics, (i.e. mimics the container-closure system); it is acceptable to use smaller packs.
– Retention samples should be securely stored in accordance with their label requirement and segregated from other materials. The conditions in the store area must be supervised and recorded.
– The storage area shall be supervised by appointed responsible person(s) from Quality Assurance.
– Access shall be restricted to authorised personnel only.
– Whenever a retention sample is required for repeated testing, etc. it can only be released from the store following a written order approval by an authorised person, e.g. the Quality Assurance Manager or delegate.
– An inventory list of every stored sample shall be kept. Any released and discarded sample shall be recorded.
– Disposal of retention samples must be in accordance with relevant EHS principles.
Related Documents
| Form-015 | Warehouse Information Form |
| Form-295 | Raw Materials Retention Sample Register Log |
| Form-300 | Finished Goods Retention Sample Register Log |
| QMS-075 | Determination of Batch Disposition |
| LAB-015 | Archiving Laboratory Documentation. |
| MAN-005 | Clothing Requirements Inside the Factory Area. |
| MAN-125 | Sampling by Production Personnel for the Analytical Laboratory |
| WAR-010 | Raw Material and Components-Incoming-Handling by Sampler. |
| EHS-015 | Waste Removal Process |
EHS Statement
a. Ensure correct lifting techniques are used when handling samples.
b. Ensure care is taken when manoeuvring pallet jacks and climbing up ladders.
c. A Spill kit is located in the retention sample room.
Procedure
1. Collection of Retention Samples
1.1. Retention Samples are collected by Warehouse Sampler (see SOP WAR-010) and QA staffs.
1.2. The following table indicates the areas responsible for collection and the delivery point.
| Product | Person / Area Responsible | Delivery Point |
| Raw Materials – Chemicals | Warehouse Sampler | Retention Sample shelf in Laboratory |
| Raw Materials – Chemicals stored between 2° – 8°C | Warehouse Sampler | ‘Retention Samples’ in Refrigerator. |
| Raw Materials – Components | Warehouse Sampler | Retention Sample shelf in Laboratory |
| Contract manufactured product | Warehouse Sampler | Retention Sample shelf in Laboratory |
| Finished Goods | Production staff | Retention Sample shelf in Laboratory |
| Finished Goods – stored between 2° – 8°C | Production staff | ‘Retention Samples’ in Refrigerator |
2. Finished Goods Retention
2.1. Retention Samples are to be individually marked with ‘R/S’.
2.2. Small boxes (e.g. tablets) are to be held together in bundles of 4 or 5 with sticky tape.
(Do not use elastic bands, unless absolutely necessary, as they perish over time).
2.3. Use Standard size Well Boxes for all products, which can be ordered through the warehouse.
2.4. Each Well Box is to be given a number that is unique and distinguishes it from all other Well Boxes. It must contain the letters RS followed by 4 digits, e.g. RS0040 is House Sample Well Box 40. This 6 digit name is what will be entered into ‘Retention Sample Register Log” (Form-300).
2.5. Samples are packed into shippers (smaller boxes) collected from the Warehouse.
2.6. Each shipper is given a letter that distinguishes it from all other shippers within the larger Well Box, e.g. H, written on the respective shipper.
2.7. After the house samples have been placed into their respective shipper or well box, the samples must be logged into “Retention Sample Register Log” (Form-300).
2.8. Once a Well Box is full of shippers, the front panel is inserted and the lid put on. The front panel must have the Well Box number (e.g. RS0040) and Date to be discarded. These are to be written as large and legible as possible.
2.9. The ‘Date to be Discarded’ is obtained by reviewing the “Retention Sample Register Log” (Form-300) and determining the longest/last expiry date. Then add one year to this date and that is the month and year for the discard date.
Example of what should be written on the front panel of the Well Box:
RETENTION SAMPLES HS0040 Well Box 40 TO BE DISCARDED: MARCH 2008 |
Also write the Well box # on the top and bottom lids on all four sides of the Well Box just in case the front panel disappears or the pallet is stored sideways.
2.9.1. When ready, the Well Box can be transported to Dispensary. Complete and attach Form-015 “Warehouse Information Form”. Extra Well Boxes and pallets can be obtained from the Warehouse.
2.10. Refrigerated Items (between 2° – 8°C)
2.10.1. Finished Good House Samples are to be individually marked with ‘R/S’.
2.10.2. All refrigerated items are stored in the Laboratory refrigerator until the expiry.
3. Raw Materials
3.1. Raw Material Retention Samples are to be individually labelled with ‘R/S’ and are temporarily stored in their respective bucket (liquid chemicals, dry chemicals and components) in the Retention Sample shelf in the Laboratory.
3.2. A “Raw Material Retention Sample Register Log” form (Form-295) is filled up.
4. Disposal of House Samples
4.1. Finished Goods
4.1.1. Finished Goods are disposed of one year past their expiry date. They are disposed of in the Security Waste reject bin (with the exception to finished good components which are disposed of 5 years after their date of arrival.
4.2. Well Boxes (Finished Goods)
4.2.1. Well Boxes are kept until the Discard date and then disposed of. The Warehouse will take care of this but it is the responsibility of the Laboratory to inform the Warehouse of the Well Box number to be discarded from the retention shelves.
4.2.2. Ensure the Retention Sample Register Log form is filled out with details of their disposal date.
4.3. Raw Materials
4.3.1. Raw Materials retention samples are to be disposed of 5 years after date of arrival through the Security Waste reject bin. (See SOP EHS-020).
4.3.2. Raw Material components are to be disposed of 5 years after the date of arrival (unless otherwise stated) into the Non Filled Security Waste reject bin.
5. Inventory and Retrieval of House Samples
5.1. Inventory of House Samples
5.1.1. It is a requirement that a sample from every batch of finished goods produced is kept for 1 year past the expiry date of the product in Retention Samples.
5.1.2. It is a requirement that a sample of every Raw Material chemical and component that comes in contact with the finished product is kept for 5 years past the arrival date in Retention Samples (unless otherwise stated).
5.1.3. All products or received Raw Materials are packed into Well Boxes or in the safe have their details entered into the respective Retention Sample Register Logs. Any Raw Material or Finished Goods retention samples can be retrievable by checking the respective log books with the corresponding Material/Product code and the batch number.
5.1.4. Only an authorise laboratory staff will be advised to collect a retention sample from the wells and a comment will be made on the log about the use of the retention samples.
6. Summary of Changes
| Version # | Revision History |
| LAB-045 | New |