| Department | Manufacturing | Document no | MAN-120 | ||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Document Owner
Operations Manager
Affected Parties
All packing operators
Purpose
To detail the amount of finished good samples required to be taken by Production Personnel for the Laboratory testing.
Scope
According to Code of GMP there should be written Sampling Plans and Procedures for starting materials, goods in process and finished goods. This SOP is to ensure that there is enough testing samples to approve the finished product for sale and ongoing stability testing.
Definition
| Sampling | The process by which representative units of a batch are taken. |
| Retention Samples | Samples from each batch of finished products retained until one year after the Expiry Date. |
| Stability samples | Samples taken at appropriate intervals and tested at appropriate intervals to determine the stability profile of the product. |
| In – Process Samples and After-Packing required or analysis. | Samples that should be representative of the batch and that are required for testing and to verify that they meet specifications before release for further manufacture or sale. |
| After-packing samples | Represent the final packed saleable product |
| Saleable Product | Product suitable for market sale and consumption. |
Related Documents
| Form-150 | Example-Logbook for Tablet Batch Documents |
| Form-315 | Stability or Trial Card |
| Form-560 | Test and Retention Sample Log Book |
| TEM-145 | Finished Product Specification and Test Report Template |
| WAR-080 | Example-Raw Material Tablet Sampling by Dispensary |
| QMS-075 | Determination of Batch Disposition |
| QMS-090 | Example-Evaluation of Batch Documentation for Tablet Packing |
EHS Statement
Care is to be taken with all samples.
1.1. All Retention samples must be representative of saleable product.
1.2. Samples must be logged into Test and Retention Sample logbook (Form-560) by production staff and logged out by QA Personnel. Test Samples are taken by Laboratory Staff according to sample required by Finished Product Specification and Test Report. (See SOP QMS-090)
1.3. Batch documents must also be logged into logbook (Form-150) by production staff. Batch Documentation should be received within 24 hours of completion of packing.
1.4. Packed Tablet Batch Documents and retention samples are evaluated by QA personnel. (See SOP QMS-090). The required laboratory test Samples are taken by laboratory Staff from the retention samples and Sign the Logbook (Form-560)
1.5. Stability samples must have the Orange Stability Card. The quantity required for stability is indicated in the “No. of boxes” which is located at the top right hand corner of the Stability Card (Form-315). The quantities indicated in the “Stability” column are to be taken ONLY from those batches where the Batch Documents have an Orange “Stability Card” attached to them but the amount to be taken on the Stability Card may vary from the amount indicated in the SOP. These samples are in-addition-to those normally taken.
Note: All samples are to be in finished saleable pack for Stability and retention Samples.
1.6. Samples required for retention samples, stability and after‑packing analysis, plus all part packs. Retention samples must be a representative from start, middle and end of manufacture.
2.1. Bulk Tablet Sampling (as raw material)
One tablet from every bulk container/ plastic bag is required to be placed in a sample jar for analysis by the Analytical Laboratory. (See SOP WAR-080)
Each manufacturer’s batch number is to be placed in a separately labelled sample jar.
After testing, these tablets are to be stored as retention Samples.
2.2. Finished Goods Sampling
Finished goods Sampling required for retention samples, test samples, stability and after‑packing samples plus all part packs.
Note: Minimum number of Tablets for Retention Samples is 100 units.
2.2.1. Tablets in jars
| Pack Size | Retention Sample |
| 100’s | 2 jars |
| 1000’s | 1 Jar |
Note: Samples of each manufacturer’s batch number must be given.
2.2.2. Tablets in blister packs
| Pack Size | House Sample |
| 7’s | 15 packs |
| 10’s | 10 packs |
| 15’s | 7 packs |
| 30’s | 4 packs |
| 60’s | 2 packs |
| 100’s | 2 packs |
2.3. Process operator has to check the corresponding Finished Product Specification and Test Report to get the required number of test samples. Sample at least twice as it is required by the specification.
2.4. Operators sample from at the start up, middle and end of the run. All cartons / bottles should have following details:
a. When the samples were taken, e.g. start up, middle or end.
b. Shipper No. from which the samples are taken.
c. Initials of the Operators taking the sample.
d. Date sample taken.
Fully Packed Imported Products Finished Goods
2.5. Receiving Warehouse
Fully packed finished goods required for retention samples and after‑packing testing.
| Product | Pack Size | Testing Samples | Retention Samples |
Total | |
Tablets/Capsules |
2 | 1 pack | 4 packs | 5 packs | |
| 7 | 1 pack | 4 packs | 5 packs | ||
| 20 | 1 pack | 1 pack | 2 packs | ||
| 25 | 1 pack | 1 pack | 2 packs | ||
| 28 | 1 pack | 1 pack | 2 packs | ||
| 30 | 1 pack | 1 pack | 2 packs | ||
| 50 | 1 pack | 1 pack | 2 packs | ||
| 56 | 1 pack | 1 pack | 2 packs | ||
| 60 | 1 pack | 1 pack | 2 packs | ||
| 90 | 1 pack | 1 pack | 2 packs | ||
| 100 | 1 pack | 1 pack | 2 packs | ||
| 150 | 1 pack | 1 pack | 2 packs | ||
3. Summary of Changes
| Version # | Revision History |
| MAN-120 | New. |