Department | Quality Management | Document no | QMS-040 | ||
Title | Shelf Life of Product | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Document Owner
Quality Assurance Manager
Affected Parties
All Colleagues
Purpose
This SOP provides directions on how to obtain the most current shelf-life and storage conditions from the Certificate of Analysis and Registration Specification.
Scope
The shelf-life SOP covers determining the expiry date of Tablet products manufactured in a gmp site for local market.
Definition
Shelf-life | The shelf-life is used to calculate the Expiry Date for products manufactured/packed at the GMP site. Shelf Life means the number of months or years for which the product will meet label claim, plus a safety margin when packed and stored as specified. |
Related Documents
TEM-005 | Raw Material Specification and Test Report Template |
TEM-150 | Packaging Material Specification and Test Report |
MAN-080 | Example-Manufacturing Instruction for Tablet Packing |
EHS Statement
There are no EHS implications as this is a document procedure.
1. Shelf Life
Table of Shelf-Life (Years and Days)
Shelf-Life (Years) | Shelf-Life (Days) |
0.5 | 182 |
1 | 365 |
1.25 | 456 |
1.5 | 547 |
2 | 730 (700*) |
2.5 | 912 (882*) |
3 | 1095 (1065*) |
4 | 1460 (1430*) |
5 | 1825 (1795*) |
* For markets that set the expiry date minus 30 days. e.g. A product prepared in January 2000 with a shelf-life of 24 months will expire in December 2001.
2. Storage Conditions for Finished Products
KEY
R Refrigerate
UP Store in an upright position
CP Store in a cool place
DNR Do not refrigerate
PL Protect from light
DNF Do not freeze
PM Protect from moisture
RDNF Refrigerate do not freeze
3. Expiry Date means the date at which the product is no longer guaranteed.
Dates of Manufacture and/or Expiry printed on products or packs will be expressed in month and year, e.g. MAR 1996, MAR 96, 03/1996 or 03 96; 0396 is not a preferred option.
Date of Manufacture means date of preparation of the product. For example:
For tablet packaging: | The month of manufacture of bulk tablets stated on the certificate of analysis |
4. Raw Material Specification and Test Report (TEM-005)
Check the respective Raw Material Specification and Test Report and The Certificate of analysis to collect the exact date of manufacture for any raw material used in the process. i.e. For the imported bulk tablets for packing in site expiry dates can be found in the supplier’s certificate of Analysis.
5. Finished Goods Specification and Test Report (TEM-150)
Check the finished goods specification and Test Report to get the shelf life and storage condition for any finished product made in Sydco. Finished goods specifications are prepared from the registration specifications for the local and foreign markets.
Summary of Changes
Version # | Revision History |
QMS-040 | New |