Reserve Sample Handling Storage and Disposal - Raw Materials

Original Document

Scanned document (image-only PDF)

Extracted Text

Searchable text extracted from PDF

Standard Operating Procedure SOP Number Revision 
 
 D-304 4 
 aauTverst” | Reserve Sample Handling, Storage, | Effective Date Page 
 and Disposal — Raw Materials (rq'\K Jo Page | of3 
 Written by/ Date Rejizwed by/ Date Approved by/ Date ; 
 SAS e 3i?r Iza (ier OK Rif 50: oe \\n 
 
 Title: Analytical Tif@: Analytital ‘~ Title: Quality Comtrol 
 Development Scientist Development Manager Laboratory Director 
 
 iloO Purpose 
 
 This procedure defines requirements for the transfer of custody ofnaw material reserve samples
 to the QE Laboratory, as well as storage and disposal ofreserve samples.
 200 
 Scope 
 
 This procedure covers receiving raw mattenial reserve samples, storage in climate monitored
 locatioms, disposal ofraserve samples and the required documentatiom to track the process. This
 procedure applies to dietary, companion amimall, cosmetic, and) phanmacauticdl raw material
 samples. 
 
 300 
 Regponsibility 
 811 QC Sampling is responsible for transporting samples to the QE laboratory and logging
 the delivery process. 
 
 22 QC Laboratony Personrd! are responsible for maintaining inventory ant arranging
 disposal of reserve samples. 
 
 833 = Itis the responsibility of @E Laboratory Management to implement this procedure and
 to ensure that the procedure is being followed. 
 
 344 It is the regponssidility of @G Laboratory Management to keep the SOP cument with
 latest Ion Labs practices. 
 
 400 
 Definitions 
 311 Reserve Sample = Representative samples of each lot or batch of API, excipiemiss,
 packaging material, intermediates, or finished products which are kept for purpose of
 future reference. 
 
 322 Dietary Active ingredient = Any ingredient in a dietary supplement that is intended to
 supplement the diet, i.e. vitamims or minerals. 
 
 $33 Active Pharmaceutical Ingredient (API) = Ingredient in a pharmaceutical or drug that
 is biologically active. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Reserve Sample Handling, Storage, and Disposal = D-304 4 | Page 2 of3 
 
 Raw Materalb 
 
 24 QE - Quality Control 
 
 855 QA - Quality Assurance 
 
 500 
 References 
 5.1 D-201, SOP, QE Laboratory Sample Log Book Recording 
 
 Fo2 E-801 , SOP, Return of Materials and Destruction of Non-Hkwandiouss Waste Materials
 
 23 E-801 .0, SOP, Handling Regulated Chemicals 
 
 54 D-501, SOP, Statility Program for Finished Products 
 
 535 D-201-Fi, Form, @Q¢€ Laboratory Sample Log 
 
 546 21 CFR Part 211.170, Reserve samples for Drugs 
 
 600 
 Procedure 
 611 Reseme raw materia! samples Will be collectatl for all dietasy active ingredients
 associated with finished product batches, limited to vitamins and minerals only.
 
 &22 Per 21 CAR PHL.NO, raw matential reserve samples willl be collected for all active
 pharmaceutical ingrediemts (API's) used in drug products. 
 
 633 Resewe samples may be collected for all raw matenidls used in finished) product
 batches, regardless of intended use, however, this is not a CFR requirement for drug
 excipients, dietary supplements, cosmetics, and companion animal products.
 
 14 Liquid raw materials are not collected and retained as reserve samples, unless the liquid
 is a drug product API. 
 
 635 Resarve samples are delivered to the QC laboratory amd the required information is
 logged! into Form D-201-Fi QC Laboratory Sample Log. For instruction om the
 infonmatiom needed and logging in reserve samples, refer to SOP D-201 Q€ Laboratory
 Sample Log Book Recording. 
 
 6 @¢ Laboratory Personnel will review the QC log entry amd verily accuracy of the
 information before accepting. Acceptance ofthe reserve sample is acknowledged by an
 entry from @G Laboratory Personnel onto the QC Laboratory Sample Log as per SOP
 
 D-201. 
 677 Reserve Sample Storage 
 
 6.7.11 Raw matetial resence samples are sioret iM @ QO Laborattory designated
 
 location. 
 
 CONFIDENTIAL; For ION Labs use only 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Reserve Sample Handling, Storage, and Disposal = D-304 4 | Page 3 of3 
 
 Raw Matera 
 
 67722 All reserve samples are stored ii desigmatat rooms with environments
 monitored as per SOP D-501 Stability Program for Dietary Supplements and
 Cosmetiss. 
 
 67/733 Raw material reserve sample storage containers will be identified in such a way
 that indicates the time in which the samples sinall be ready for destucttion. For
 example, a raw material is located in the fifth box identified for destiruction in
 Quarter | of 2025. The storage container should be labeled as “QI-25-5” or as
 
 applicable for indication. 
 6.8 Disposal 
 
 611 All API's must be maintaimed for at least one year past the expiration date oftthe
 last lot of drug prodwet contzimimg the AHI. lom Laboratories will maintain
 
 API's for 7 years after receipt. 
 6822 All dietary active ingredient raw material reserve samples must be maintaimed
 
 for five years from date of receipt. after which, they may be discarded following,
 SOP E-801 Retum of Materials ant) Destruction of Non-Hazardous Waste
 Materials. 
 6333 Controlled Substances are to be disposal! of as par SOP E-801.0 Handling
 
 Regulated Chemicals. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 4 | 97/20/20 | Update Responsibilities. Update References CCZDAHI3 S. Sassinan | - | - |

 CONFIDENTIAL; For ION Labs use only