Finished Product Reserve Samples

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1.0 Purpose 
 The purpose of this SOP is to define the process for the sampling, storage, and disposal of
 finished product reserve samples. This procedure also defines the process and parameters to
 help ensure an appropriate representative sample of each batch of finished product is reserved
 in sufficient quantities and stored in the appropriate environment. 
 
 2.0 Scope 
 
 This procedure applies to all products manufactured at Ion Labs, Inc. 
 3.0 Responsibility 
 
 331 It is the responsibility of QC to obtain samples of finished product and deliver the
 samples to the QC Laboratory. 
 3.2 It is the responsibility of the QC Laboratory to store and maintain reserve samples.
 
 4.0 Definitions 
 
 4.1 Reserve Sample — Finished product stored in its finished product container if bottled or
 blister packed, or stored in a suitably sized container for products shipped in bulk
 packages. 
 4.2 QC - Quality Control 
 
 5.0 References 
 5.1 E-702, SOP, Finished Product Sampling Procedure 
 
 5.2 D-201-F1, Form, QC Laboratory Sample Log Book 
 5.3 E-801.0, SOP, Handling Regulated Chemicals 
 
 5.4 D-105, SOP, Out of Specification / Out of Trend Investigation 
 
 5.5 21 CFR 111.83, What are the requirements for reserve samples? (Dietary Supplements)
 
 5.6 21 CFR 111.465, What requirements apply to holding reserve samples of dietary
 supplements? 
 
 S57 21 CFR 211.170, Reserve samples (OTC Pharmaceuticals) 
 5.8 21 CFR 211.137, Expiration dating (OTC Pharmaceuticals) 
 
 6.0 Procedure 
 
 6.1 Sampling 
 
 
 

[SOP 

 L 
 Standard Operating Procedure SOPNo | Rev 
 Finished Product Reserve Samples D-404 8 Page 2 of 3 
 
 6.1.1 QC inspectors will select finished product packages and bulk product from each
 finished product batch using SOP E-702 Finished Product Sampling Procedure.
 6.1.2 QC inspectors will deliver samples to the QC Laboratory and log them onto
 Form D-201-F1 QC Laboratory Sample Log Book. 
 
 6.1.3 Reserve Samples will be held in the same container/closure in which the
 packaged and labeled finished product is distributed. 
 6.1.4 The reserve sample consists of at least twice the quantity necessary to perform
 
 all the required tests. 
 6.1.5 Deviation from the default reserve sampling procedure will occur in the
 following instance: 
 
 6.1.5.1 The default number of six reserve samples can be reduced to a number
 no less than three bottles when sufficient dosages exist in a reserve
 sample to justify a reduced number of packages. The reserve quantity
 must meet the requirements of21 CFR 111.83 or 21 CFR 211.170.
 6.1.5.2 Justification for reduced reserve sampling will be listed in the
 exemption section of the product profile. 
 
 6.2 Storage 
 6.2.1 Reserve samples are to be stored at monitored room temperature and humidity
 conditions. 
 
 6.2.2 Reserve samples are to be stored and maintained in a manner that allows for
 easy retrieval. 
 
 6.2.3 Specific location of reserve samples are logged into an excel spreadsheet and
 tracked by box number. 
 6.2.3.1 Reserve samples may be stored in 12” X 12” X 24” brown boxes with
 the inventory listed on the outside of the box. 
 
 6.2.3.2 Individual reserve samples should only be removed from the program if
 justified, ie. customer complaint investigation. 
 6.2.3.3 Ifa reserve sample is removed from the program then a notation into the
 spreadsheet should be made for accountability purposes.
 
 6.3 Inspection- Drug and OTC products only 
 6.3.1 All Finished Product Drug and/ or OTC reserve samples will have an annual
 inspection performed. 
 
 6.3.2 Each FP lot will be visually examined for any sign of deterioration.
 6.3.3 The results of the inspection will be recorded and maintained with other stability
 data on the drug product. 
 
 6.3.4 If product deterioration is observed then an investigation shall be performed per
 SOP D-105. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev Pave 3 of3 
 Finished Product Reserve Samples D-404 8 g 
 
 6.4 Disposal 
 
 6.4.1 Finished Product samples are reserved for one year past the shelf life date (if
 shelf life dating is used), or for three years from the date of manufacture for
 each batch of finished product that does not have an expiration date assigned.
 
 6.4.2 During storage, any evidence of reserve sample deterioration should be
 investigated. The results of the examination will be recorded and maintained
 with other stability data if applicable. 
 6.4.3 After the reserve period, reserve samples are identified and removed the month
 following reserve expiration, or as time allows, using safe disposal practices.
 
 6.4.3.1 Product containing listed substances will be disposed of as per SOP
 E-801.0 Handling Regulated Chemicals. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/16/10 | New = a | - | - |
| 1 | 07/29/10 | Organized SOP. : z | - | - |
| 2 | 03/27/13 | Updated SOP to new format. é o | - | - |
| 3 | 06/06/13 | Changed SOP number. : : | - | - |
| 4 | 12/12/13 | Changed SOP title. Edited SOP content. 13-1153 M. Wienke | - | - |
| 5 | 11/26/14 | Acces section 6.1.3 and 6.1.4. Updated SOP format and section 6321; 6 TAMAS’ U c p e d n at , e S A O d P d e t d o D i - nc 1 l 0 u 2 d . e 0 , O D T - C 1 0 f 5 in a is n h d e d D - pr 8 o 0 d 1 u . c 0 t s r . e f R e e r f en e c r e e s n , c ed 211 series 16-1142 _B. Johns | 14-0943 | V. IItcheva |
| 7 | 04/07/17 | Updated storage practices for new facility. 8 1127/19 R f o r o e sample clarification. Added Inspection of Drug 19-0885 J. Sassman | 17-0397 | B. Johns |