D-602
Labeling and Expiration Dating of Laboratory Chemicals and Microbiology Inventory
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1.0 Purpose The purpose of this procedure is to give guidelines on expiration dating and labeling of laboratory chemicals, reagents, and media used in the QC Laboratory. This procedure will also define storage conditions for various chemical classes and give guidelines on logging the chemical inventory. 2.0 Scope This procedure applies to all dry chemicals, organic solvents, prepared reagents and buffers, and microbiological media for intended use in QC Laboratory testing. 3.0 Responsibility 3.1 It is the responsibility of QC Laboratory Analysts to follow this procedure. 3.2 It is the responsibility of QC Laboratory Management to implement this procedure and to ensure the procedure is being followed. 3.3. It is the responsibility of QC Laboratory Management to keep this procedure up to date with current practices. 4.0 Definitions 4.1 Reagent — a compound or mixture added to a system to cause a chemical reaction or test if a reaction occurs 4.2 Buffer —a solution containing either a weak acid and its salt or a weak base and its salt, [SOP Standard Operating Procedure SOP No | Rev Labeling and Expiration Dating of Laboratory D-602 9 | Page 2 of6 Chemicals and Microbiology Inventory which is resistant to changes in pH 4.3 Solvent — the component of a solution that is present in the greatest amount. It is the substance in which the solute is dissolved. 4.4 SDS — Safety Data Sheet 4.5 QC — Quality Control 4.6 Media — a mixture of substances that promotes and supports the growth and differentiation of microorganisms 4.7 CofA — Certificate of Analysis 4.8 PQV — Process Quality Verification 5.0 References Dad D-106, SOP, Analytical Standards D2 USP <1117>, Pharmacopeial Monograph, Microbiological Best Laboratory Practices 5.3 D-602-F1, Form, Microbiology Inventory Log 5.4 A-106, SOP, Documentation Guidelines for cGMP Records 54d C-501, SOP, Document Control Procedure 5.6 C-502, SOP, Record Storage, Retention, and Destruction 6.0 Procedure 6.1 General 6.1.1 Chemicals and microbiology media are delivered to the laboratory by warehouse receiving. [SOP Standard Operating Procedure SOP No | Rev Labeling and Expiration Dating of Laboratory D-602 9 | Page 3 of6 Chemicals and Microbiology Inventory 6.1.2 Warehouse receiving lists are used to verify inventory of received materials before taking custody. 6.1.3. Chemicals or media are received by QC Laboratory Management or designee and stored in the correct location. 6.2 Chemicals and Media Labeling 6.2.1 All chemicals and powder media received into the QC laboratory will be labeled with the following information: 6.2.1.1 Date of Receipt and Receipt Expiration Date 6.2.1.2 Date Opened and Opened Expiration Date 6.2.2 Commercially pre-made media received into the QC laboratory will be labeled with quarantine stickers, to indicate media verification is needed before use. 6.3. Solution Preparation Labeling 6.3.1 It is the expectation that all laboratory preparations can be traced back to the notebook or document in which the preparation occurred. 6.3.2 All solutions prepared in the laboratory will be clearly labeled with the following information (the UNIX method) 6.3.2.1 U — Unique identifier name (ex — D-XXX Standard, Batch/Lot #, Sample 1) 6.3.2.2 N-—Notebook number and page number (ex — NB 98-112) 6.3.2.3. I—Initial and date of the analyst who prepared the solution 6.3.2.4 X-Expiration date of solution preparation 6.4 Expiration Dates [SOP Standard Operating Procedure SOP No | Rev Labeling and Expiration Dating of Laboratory D-602 9 | Page 4 of 6 Chemicals and Microbiology Inventory 6.4.1 Expiration dates defined below should not exceed a manufacturer’s expiration date for any reagent/solution. The manufacturer’s CofA will be evaluated upon receipt per section 6.2. 6.4.2 Reference Standard Expiration Dates 6.4.2.1 Analytical Reference Standards — refer to SOP D-106 Analytical Standards. 6.4.3. Expiry Dating of Laboratory Chemicals, Solutions, and Microbiology Media Sample/Solution Type Expiration Date as Received ager castenpe fo — Dry Chemicals 5 years 2 years Organic Solvents, i.e. methanol, ACN, IPA, etc. 2 years | year USP Test Solutions (TS) (purchased) 2 years 1 year pH Buffers (used for calibration of pH meter) 1 year 6 months Acids < 1N, purchased 1 year 6 months Acids > 1N, purchased 2 years 1 year Bases < 1N, purchased! 1 year 6 months Bases < 1N, purchased! 2 years 1 year Volumetric Solutions? 1 year 6 months Acids/ Bases < 1N, prepared! 3 months Acids/ Bases > 1N, prepared! 6 months Mobile Phases/ Diluents < 10% organic 1 month Mobile Phases/ Diluents > 10% organic 3 months Buffer Solutions 1 month 1 year (unless otherwise USP Test Solutions (TS) (prepared) specified by USP) 1 day unless otherwise Sample/ Standard Preparations? specified in test method Organic Solvents (100%) used as Mobile Phase on ‘sonthe HPLC Microbiological Media (Powder) 5 years 2 years Microbiologic Media Prepared In-House 30 days 1. Certain bases will degrade when exposed to air and may require a shorter expiration date. 2. The expiration dates for volumetric solutions may be extended if the solution is re-standardized per the USP. 3. For example, samples/ standards prepared on Monday do not expire until midnight on Tuesday. [SOP Standard Operating Procedure SOP No Rev Labeling and Expiration Dating of Laboratory D-602 Page 5 of 6 Chemicals and Microbiology Inventory 7.0 Inventory Reagent List 7.1. The laboratory shall keep an updated inventory list of all reagents and chemicals used for testing. Microbiology will use Form D-602-F1 Microbiology Inventory Log. 7.2 This list will include, at minimum, reagent name, vendor, lot number, grade (if applicable), receipt date, and expiration date. 7.3. Upon receipt into the QC laboratory, all reagents will be stickered as previously noted and entered into the inventory reagent list. 7.4 This list will be easily produced at all times and for any audit requests. 8.0 Documentation Requirements 8.1 A PQV check must be performed for each completed page of form D-602-F1 Microbiology Inventory Log as outlined in SOP A-106 Documentation Guidelines for cGMP Records. 8.2 All documentation will be distributed and maintained as outlined in SOP C-501 Document Control and SOP C-502 Record Storage, Retention, and Destruction. [SOP Standard Operating Procedure SOP No | Rev Labeling and Expiration Dating of Laboratory D-602 9 | Page 6 of 6 Chemicals and Microbiology Inventory 9.0 Revision History | Rev | Date | Description of Changes | CCR # | By | |-----|----------|------------------------|-------|----| | 0 | 05/06/10 | New procedure. - - | - | - | | 1 | 01/24/12 | Updated format. - - Defined logging procedures for standards, expanded on MSDS, | - | - | | 2 | 02/18/13 | ; : anes - - adjusted parameters for expiration Removed logging procedures for standards, reorganized logging system for chemical inventory, added form D-602-F1, expanded | - | - | | 3 | 10/24/13 | chemical storage areas, increased detail for determining expiration date, added certification procedure for certain expired chemicals, changed SOP title | 13-952 | B. Johns | | 4 | 06/15/16 | Biennial review: Updated SOP Format. Updated SOP to expand recertification of laboratory chemicals. ; CRIS Expanded criteria for justifying shelf life of reagents and media. ike Beas | 16-0205 | J. Maignan | | 6 | 09/03/19 | arse SOP to align with current laboratory and industry | 19-0599 | L Garrett | | 7 | 03/28/22 | Updated to add the requirement of a laboratory inventory reagent CC- list, per ISO 17025. 09/14/22 Updated with microbiological media inventory. CC-22-0255 G. Shaw 06/05/24 Updated to reflect current practices CC-24-0243 A. Perez | 22-0141 | j, Savane | [SOP AOd