1. Purpose
The purpose of this Guideline is to outline the requirements in the expiration dating of all analytical reagents and solutions prepared from these reagents. Recommendations are also included on how to achieve compliance.
2. Scope and Applicability
This Guideline is applicable to all manufacturing Operations sites operating laboratories required to meet GMP and/or ISO standards. It applies to all analytical reagents used in analytical work, excluding those associated with Biological Drug Products.
3. Definitions
None.
4. Responsibilities
It is the responsibility of each laboratory manager to establish, document and operate procedures to assign expiry dates to reagents, and solutions prepared from reagents, and record these on each container at the time of receipt (reagents) or preparation (solutions).
5. Guideline
5.1 Purchased Reagents
5.1.1 On receipt of purchased reagents the date should be recorded on each container so that it’s approximate age is subsequently known. An expiry date as well as the opening date must be added when the reagent is taken into use in the laboratory.
5.1.2 Where the supplier’s label or catalogue indicates specific storage conditions then these must be strictly observed.
5.1.3 Where no conditions are specified then material must be stored in sealed containers at room temperature, in an area preventing exposure to excessive heat and humidity, and commensurate with the potential hazard of the material. Example: Flammable reagents and solvents must be stored in fire resistant cupboards. Large packages and hazardous material must be stored in fire resistant cupboards and near the ground. Material producing toxic fumes must be stored in a fume cupboard or ventilated area.
5.1.4 During their life in the laboratory, care should be taken that in-use contamination is avoided.
5.1.5 If there is any doubt about the acceptability of a reagent it must be either re-tested before use, or if this is not possible, it must be discarded and a new supply obtained.
5.2 Laboratory Prepared Reagents
5.2.1 These are normally solutions, for example, volumetric, buffers, indicators, reference standards and general reagents. They must be stored in suitable glass or plastic containers and labeled with:
– The name of the reagent
– Strength and/or factor
– Date of preparation and/or standardization
– Initials of person preparing the reagent
– Expiry date
– Storage conditions
– Reference to the source of raw data (if possible)
5.2.2 The Chemistry Manufacturing Control (CMC) Dossier may contain comments such as ‘prepare fresh,’ ‘standardise immediately before use,’ ‘protect from light,’ ‘store in a plastic container’ etc. these conditionswhere specified must be strictly adhered to.
5.3 Test of Reagent
When necessary, tests should be performed to confirm that reagents are suitable for their intended purpose, e.g. positive or negative controls to verify the suitability of microbiological culture media. Tests on reagents should be recorded.
5.4 Storage Lives
5.4.1 Specific Recommendations
– Unless stated on the container or experience dictates otherwise, solid reagents will normally be stable for a period of 5 years if correctly stored.
– Buffer solutions must be discarded after 3 months unless otherwise specified.
– Solutions used, as reference standards for limit tests must be prepared immediately before use and discarded after use.
– Volumetric solutions of Molarity less than 0.01 M must be prepared immediately before use and then discarded after use.
5.4.2 General Recommendations
A storage life of 12 months should generally be adopted for all solutions of reagents or indicators unless otherwise stated above or in the CMC Dossier or if experience indicates otherwise. Volumetric solutions must be re-standardized at least monthly.