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LAB-035 Managing Analytical Reagents - Pharmaceuticals quality assurance & validation procedures GMPSOP

The document outlines the Standard Operating Procedure (SOP) for managing analytical reagents in a laboratory setting, emphasizing the importance of labeling reagents with expiry dates and storage conditions. It details the procedures for handling purchased and laboratory-prepared reagents, including storage requirements and contamination prevention. The SOP also specifies the expected shelf life for various types of reagents and solutions, ensuring compliance with safety and quality assurance standards.

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ashwande256
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55 views4 pages

LAB-035 Managing Analytical Reagents - Pharmaceuticals quality assurance & validation procedures GMPSOP

The document outlines the Standard Operating Procedure (SOP) for managing analytical reagents in a laboratory setting, emphasizing the importance of labeling reagents with expiry dates and storage conditions. It details the procedures for handling purchased and laboratory-prepared reagents, including storage requirements and contamination prevention. The SOP also specifies the expected shelf life for various types of reagents and solutions, ensuring compliance with safety and quality assurance standards.

Uploaded by

ashwande256
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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10/15/23, 9:59 AM LAB-035 Managing Analytical Reagents - Pharmaceuticals quality assurance & validation procedures GMPSOP

LAB-035 Managing Analytical Reagents

Department Laboratory Document no LAB-035

Title Managing Analytical Reagents

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
To identify the need for all analytical reagents, and solutions prepared from the reagents, to have an
assigned expiry date and storage conditions recorded on the label.

Scope
This SOP is applicable to all analytical reagents used in analytical works. It is the responsibility of
Laboratory staff to ensure correct procedures are followed when receiving reagents.

Definition
MSDS Material safety Data Sheet

Related Documents
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10/15/23, 9:59 AM LAB-035 Managing Analytical Reagents - Pharmaceuticals quality assurance & validation procedures GMPSOP

Form-280 Reagent Storage Location Form

Form-285 Prepared Reagent Label Form

LAB-020 Management of Reference Substances

EHS Statement
When handling chemicals, the Laboratory staff must wear safety glasses and be aware of any potential
hazards regarding the chemical in use. Always follow MSDS before handling the chemical.

Procedure
1. Purchased Reagents

1.1. On receipt of purchased reagents the date should be recorded on each container so that its
approximate age is subsequently known. If multiple containers of one reagent have been received, they
should be labelled ‘X of Y’ (e.g. 1 of 4, 2 of 4, 3 of 4, 4 of 4). The order book should also be signed off at
this time and the person who ordered the reagent informed if its arrival. An expiry date as well as the
opening date should be added when the reagent is taken into use in the laboratory.

1.2. Where the supplier’s label or catalogue indicates specific storage conditions then these should be
strictly observed.

1.3. Where no conditions are specified then the material should 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. Refer to Form-280 for reagent storage locations.

1.4. During their life in the laboratory, care should be taken to avoid in-use contamination. It may be
useful to divide a large quantity of reagent into smaller containers to prevent contamination to the
entire quantity. This is especially useful for reagents, which are very hygroscopic.

1.5. If there is doubt about the acceptability of a reagent it should either be retested, or if this is not
possible a new supply obtained.

2. Laboratory Prepared Reagents

2.1. Laboratory prepared reagents are usually solutions, for example buffers, indicators, and reference
standards. They should be stored in suitable glass or plastic containers. Acidic solution must be stored
in glass containers and alkaline solution must be stored in plastic containers. Do not use metal
container to store either acidic or basic solution. Reference standards may be stored for the duration of
their shelf life in volumetric flasks, if necessary. However, volumetric flasks are NOT suitable storage
containers for testing solutions and may only be used for short-term storage.
All containers must be labelled with Prepared Reagent Labels Form-285. Information includes

a. The name of the reagent


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10/15/23, 9:59 AM LAB-035 Managing Analytical Reagents - Pharmaceuticals quality assurance & validation procedures GMPSOP

b. Strength and /or dilution

c. Date of preparation and/or standardisation

d. Date of re-standardisation

e. Initials of the analyst who prepared the reagent

f. Expiry date

g. Storage conditions

h. Reference to the raw data, i.e. analysts book and page number.

2.2. Preparation and storage conditions should be strictly adhered to (for example, ‘prepare fresh’,
‘standardise immediately before use’, protect from light’, store in a plastic container’ etc.).

3. Storage Lives

3.1. Unless otherwise stated or experience dictates otherwise, solid reagents will normally be stable for
a period of five (5) years if stored correctly. No reagent will be kept for more than five years.

3.2. Buffer solutions should never be kept for more than three months unless otherwise stated.

3.3. Solutions used, as reference standards for limits tests should be prepared immediately before use,
and discarded after use.

3.4. Stock standard solutions for 2,6 DMA (Di-Methyl Acetate) may be kept for up to 3 months in the
fridge (due to these materials being in very short supply). The stock must be freshly diluted for each
use.

3.5. Volumetric solutions of Molarity less than 0.01M should be prepared immediately before use and
then discarded after use. Volumetric solutions of greater than 0.01M should be re-standardised
monthly.

3.6. HPLC standards may be kept for a maximum of four (4) weeks unless otherwise stated in the
control method, after which they should be discarded.

3.7. Generally an expiry of twelve (12) months is acceptable for all solutions of reagents or indicators
unless otherwise stated above.

4. Summary of Changes

Version # Revision History

LAB-035 New

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