In this Sop, we will explain about Handling Of Chemicals, Reagents And Solutions In Laboratories in the Pharmaceutical Industry.
This SOP describes the Handling Of Chemicals, Reagents And Solutions In Laboratories.
This sop is applicable to chemicals to chemicals, reagents and solutions used for chemical testing in QC Department.
Quality control chemist
- Reagents growth media and chemicals :
4.1.1 Receipt of Reagents, growth media and Chemicals
4.1.2 It is important for the laboratory staff member receiving the chemicals to be aware of the proper handling, storage, and disposal of the chemical. This information can be obtained from the Material Safety Data Sheet(MSDS) which is usually sent with the chemicals. All chemicals MSDS are also to be stored in a commonplace in the Laboratory where they can be easily accessed. Upon receipt examine the container of any new reagent or chemical for damage.
4.1.3 Damaged materials are to be returned to the supplier or disposed of according to established procedure.
4.1.4 Upon receiving a receiving date is assigned to each label.
4.2 Opening date of reagents and chemicals
4.2.1 When a container is first opened, initial and record the date on the label.
4.3 Expiration Of Reagents media And Chemicals
4.3.1 Expiration Date After Opening Is Assigned And Written On Each Label.
4.3.2 Use the supplier label recommendation and initial and record the date on the label.
4.3.3 If not indicated on original supplier label an expiration date of not more
than five years from receipt is assigned to all reagents and chemicals
when know to be very stable
4.4 Reagents/solutions labels prepared in-house should be labelled with the following information:
Stick a ” label (see below) on each bottle of chemical and fill in the necessary
Reagent /Chemical Sticker
|· Name of the reagent/solution|
|· Lot /Batch No||As Per Manufactures Label|
Growth media Sticker
|Media||Q C No.|
|Mfg date||Exp date:
|No. of Packs___||Growth: conform|
|QUALITY CONTROL DEPARTMENT|
- INVENTORY OF REAGENTS AND MEDIA
5.1 It is important to have an inventory of all the reagents and media present in the laboratory
- STORAGE OF REAGENTS AND MEDIA
6.1 REAGENTS STORAGE
- 1.1 Chemicals should be stored in a manner that minimizes exposure to hazardous substances, chemical spills, the possibility of fire or explosions, and reactivity hazards. The storage of chemicals will depend on its nature, whether it is radioactive, flammable, corrosive or combustible. Always refer to its package instructions or its MSDS on its storage guidelines.
- 1.2 Chemicals in the Laboratory or Stores are to be stored in appropriate cabinets and shelves according to the following guidelines:
6.1.3 Chemicals should be stored in an uncluttered manner on shelves with a solid back and side frames that are firmly secured.
6.1.4 Avoid storing chemicals in passageways, under tables, on bench tops, in hoods or stored as to block emergency equipment or exit areas.
6.1.5 Volatile toxic substances and odoriferous chemicals should be stored in a ventilated cabinet.
- 2 MEDIA STORAGE
- 2.1 Dehydrated media is to be stored in a cool, dark, minimal humidity environment e.g. not near autoclaves. The higher the environment moisture content, the greater the possibility of degradation of the various constituents of the medium. If stored under desirable conditions, most dehydrated media will remain in good condition for several years. However, a few products, which contain ingredients of high sensitivity, are less stable especially if the moisture is allowed to rise.
- 2.2 Do not open Media containers for prolonged periods. Carefully close the media containers lid/closure when closing containers to maximize shelf-life. Do not use dehydrated media that are caked, cracked or have shown colour change.
- 2.3 Store supplements and additives appropriately e.g. under refrigeration where this is required.
- 2.4 Store light-sensitive chemicals in the dark or wrap in aluminium foil.
7.0 Establishment of expiry dating for chemicals, reagents, solutions, and solvents.
Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at 211.194, include laboratory chemicals such as solvents (including mobile phases), dry chemicals (salts, primary standards, etc.), and solutions (buffers, acids/bases, quantitative analytical preparations, etc.), whether purchased or prepared in-house. Laboratory reagents and solutions are used in analytical tests of components, in-process materials, and finished products.
If the purchased laboratory reagent or solution includes a manufacturer’s suggested “use by” or expiry date, that date should be followed. For purchased laboratory reagents and solutions without a “use by” or expiry date, FDA suggests that an assessment be conducted (literature review may be acceptable) of that specific chemical’s or chemical family’s stability and that an appropriate “use by” or expiry date be determined.
For in-house prepared solutions, such as mobile phases or other non-quantitative solutions, FDA suggests that an assessment be conducted (again, a literature review may be acceptable) to determine an appropriate expiry period. However, for in-house prepared solutions used for quantitative analysis, such as sample or standard solutions used in assay or impurity testing or titration solutions, FDA requires that formal stability studies be conducted to determine an appropriate expiry.
The determined “use by” or expiry dates should be documented within a procedure and followed. Procedures for any in-house prepared laboratory solution should include the determined stability timeframe and should instruct that these solutions be labelled with the appropriately determined “use by” or the expiration date upon preparation and discarded upon expiration.
- Disposal of expired chemicals, reagents and solutions
Date expired chemicals, reagents and products considered unfit for further use will be disposed of as soon as possible. MSDS will be consulted to find the appropriate manner for disposal.
The following Quality Records shall be generated and managed in accordance with the Procedure for Control of Company Quality Records (4.12).
|Required Record||Form Reference No.|
|“Lab Reagents Label|
|Growth media label|
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