SOP for Maintenance, Process & Record of Reagents, Solutions

(Formerly known as Ess Dee Aluminium Ltd.)

and Standards

PURPOSE

• 1.1 To define the procedure for the maintenance, preparation, standardization, storage and record-keeping of chemicals, reagents, solutions and reference standards used in laboratory testing.

SCOPE

• 2.1 This SOP applies to all chemicals, purchased reagents, standard operating solutions (Volumetric, Molar, Normal), indicator solutions and reference standards used in laboratory testing.

REFERENCE(S) & ATTACHMENTS

• 3.1 References
  • 3.1.1 ISO 15378:2017
• 3.2 Attachments
  • 3.2.1 NIL

RESPONSIBILITY

• 4.1 Warehouse Department Person
  • 4.1.1 To prepare the SOP.
  • 4.1.2 To prepare a list of the SOP in the Warehouse Department.
• 4.2 Production Head
  • 4.2.1 To ensure the training of the SOP to all concerned department personnel involved in implementation of the SOP.
  • 4.2.2 To ensure the implementation of the SOP after training.
• 4.3 Quality Assurance Person
  • 4.3.1 To check the SOP.
  • 4.3.2 To maintain the original copy of the SOP.
  • 4.3.3 To issue the controlled copy of the SOP.
  • 4.3.4 To maintain the issuance record of the SOP.
  • 4.3.5 To retrieve the controlled copy of the SOP when it is superseded/obsolete and maintain its record.
• 4.4 QA Head
  • 4.4.1 To approve the new or revised SOP.
  • 4.4.2 To ensure the implementation of the defined system.
• 4.5 Plant Head
  • 4.5.1 To approve the new or revised SOP.
  • 4.5.2 To ensure the implementation of the defined system.

DISTRIBUTION

• 5.1 Quality Control
• 5.2 Production
• 5.3 Quality Assurance
• 5.4 Warehouse
• 5.5 Engineering Department

DEFINITION(S) & ABBREVIATION(S)

• 6.1 Definitions: Nil
• 6.2 Abbreviations: Nil

(Formerly known as Ess Dee Aluminium Ltd.)

and Standards

PROCEDURE

• 7.1 General Reagent Requirements
  • 7.1.1 Grading: All chemicals used must be Analytical Reagent (AR) or Laboratory Reagent (LR) grade, or traceable to National Institute of Standards and Technology (NIST) where applicable.
  • 7.1.2 Verification: Ensure containers are physically intact and labels are clear before opening.
• 7.2 Labelling Requirements
  • 7.2.1 Each container must be securely labelled at the time of receipt and preparation.
  • 7.2.2 Receipt Label: Date of receipt and date of first opening.
  • 7.2.3 Preparation / Standardization Label:
  • 7.2.3.1 Name / Identity of the Reagent / Solution.
  • 7.2.3.2 Unique Solution ID.
  • 7.2.3.3 Date of Preparation.
  • 7.2.3.4 Normality / Molarity / Concentration.
  • 7.2.3.5 Standardization Factor (if applicable).
  • 7.2.3.6 Date of Expiry / Re-standardization due date.
  • 7.2.4 Initials of the preparer.
• 7.3 Preparation & Standardization
  • 7.3.1 All preparations must follow the documented, validated methodology (e.g., pharmacopeial monographs).
  • 7.3.2 Use calibrated analytical balances and volumetric glassware for measuring.
  • 7.3.3 Standardization: Primary and secondary standard solutions must be standardized upon preparation. The standardization must be repeated periodically (re-standardized) or whenever the solution nears its assigned shelf life.
• 7.4 Storage Conditions
  • 7.4.1 Store all reagents, solutions and standards according to the manufacturer safety data sheets (MSDS/SDS) and product specifications.
  • 7.4.2 Light-Sensitive Solutions: Store in amber-coloured glass bottles.
  • 7.4.3 Temperature: Monitor and record storage temperatures (e.g., room temperature, 2°C to 8°C for cold storage) daily.
• 7.5 Maintenance of Records & Logs
  • 7.5.1 Reagent Receipt Log:
  • 7.5.1.1 Name of Manufacturer / Supplier.
  • 7.5.1.2 Batch / Lot Number.
  • 7.5.1.3 Date of Receipt.
  • 7.5.1.4 Quantity received and Expiry Date.
  • 7.5.1.5 Storage conditions upon arrival.
  • 7.5.2 Solution Preparation & Standardization Log:

(Formerly known as Ess Dee Aluminium Ltd.)

and Standards

• 7.5.2.1 Name / Concentration of the solution.
• 7.5.2.2 Lot number of the raw chemicals used.
• 7.5.2.3 Weights / Volumes used for preparation.
• 7.5.2.4 Calculations for Normality / Molarity / Factor.
• 7.5.2.5 Date of Preparation.
• 7.5.3 Reference Standard / Impurity Log:
• 7.5.3.1 Detailed tracking for high-value or highly controlled standards.
• 7.5.3.2 Date of usage and amount consumed.
• 7.5.3.3 Remaining balance in the container.
• 7.6 Expiry & Disposal
  • 7.6.1 Purchased Reagents: Unless stated otherwise by the manufacturer, purchased solid reagents should generally not be kept for more than 5 years after opening, provided they remain uncontaminated. Liquid reagents/solutions usually expire 2 years from the date of opening.
  • 7.6.2 Lab-Prepared Solutions: Follow validated shelf lives. If any solution shows signs of precipitation, turbidity, discoloration or microbial growth, discard it immediately regardless of the expiration date.
  • 7.6.3 Disposal: Expired or contaminated standards and reagents must be disposed of according to the facility's Hazardous Waste Management

Sop.

• 7.7 Responsibility
  • 7.7.1 Analyst / Technician: Prepares solutions, performs standardization, and logs entries in the respective registers.
  • 7.7.2 QC Manager / Designee: Reviews and verifies all data, calculations and logs for accuracy.

REVISION HISTORY

Effective Revision No. 00 CC No. Date

Details of revision: New SOP