D-901
Raw Material Life Cycle and CoA Challenge Process
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Standard Operating Procedure SOP Number Revision J@N LAB: Raw Material Life Cycle and CoA ae 2 QUALITY FIRST Chall P Effective Date Page Ol-o%. +O | Page lof 8 Writtem by/ Date Reviewed by/ Date Approved by/ Date firs otrlo tH t5 o GP ABIOE = JOI i N >S) _ ) o\ ' I cww ' nened Title: Analytical Developrmemt | Tithe: R&D Manager Title: QE Laboratory Director Scientist iLoO Purpose The purpose of this SOP is to desoribe the lifecycle of a raw material including creation of a record in BatchMaster, creaiion/revision ofttme Raw Material Profitle, testing, release, and CoA challenge process. 200 Scope This procedure applies to alll incoming raw materials at lon Labs. This procedure does not apply to the logging of raw material samples, investigating OOS results, the post-Q¢ Lab raw material release process, the reoentification of expired raw materials, or to the reassignment of a raw materiaI to an alternate RMID. 800 Responsibility 811 It is the respumsibility of Purchasing to source appropriate raw materials. 2 R&D is responsible for creating records in BatchMaster for new taw materials. 233 It is the responsibility of Purchasing to place purchase orders for RMs and to obtain the CoA for each material ordered. B4 The Q€ Laboratory and R&D are responsible for approving raw materials, selecting the required testing, and generating the Raw Material Profile for each unique raw material. 835 The @€ Laboratory is responsible for setting specifications with assistance from R&D. 6 It is the responsibility of the Warehouse to add the R# spawifie raw material information into Batchmaster. 37/ It is the responsibility of @G Samplers to deliver the appropriate RM samples to the QE Laboratory. 288 The Q@G Laboratory is respumsiblle for release testing, coordinating extermall laboratory testing, documenting the results ofsuch testing, reviewing the final data, and suitymitting the results to DC for release of the raw material. RY It is the responsibility of DC to maintain all original Raw Material Profiles and the QAM Ljist. CONFIDENTIAL; For ION Labs use only [SOP Standard Operatiing Procedure SOP No Rev Page Raw Material Life Cycle and CoA Challenge Prowsss D-9011 8 2 of 8 AaO Definitions At APML = Approved Product Material List 422 CoA ~ Certificate of Analysis A33 DC = Document Control As4 LOD = Loss on Drying AS5 OOS = Out of Specification 466 QiKG. Over the Counter A7/ QE = Quality Control Ag8 QRNi List - Queliified Raw Material List; electronic spreadsheet maintained by DC which lists all RMs that have passed the CoA Challenge process. A99 R# = A unique identityimg number assigned to raw materials upon receipt 4140 R&D = Research and Development 4111 RM = Raw Material 4142 RUDD Raw Material Identification 4113 RMTS = Raw Material Testing Summary 500 Referemses 5.1 C-201, SOP, Deviation and [nvestigation Procedune 2 C-403. SOP, Change Control Procedune 33 C-601, SOP, New Product Approval Process 4 D-105, SOP, Out of Spacification/Out of Trend hvestigation id D-109, SOP, Qualitative Standards 6 D-902, SOP, Establishment of Spacilications 57/ E-601, SOP, Vendor Qyatification 600 Raw Material Manufacturer Selection Prosess 611 Raw material manutfacturer selection is led by Purchasing and approved by R&D as part of the formulation process. &22 Befwre a raw material intended for a pharmaceutical formulation can be purchased, the manufacturer should be qualified by QA. 3 Before a material is purchased for a pharmacautical formulation, the CoA of ead lot should be reviewed and approved by QE. CONFIDENTIAL; For ION Labs use only [SOP Standard Operating Procedure SOP No Rev Page Raw Material Life Cycle and CoA Challemgez Process D-901 8 3 of 8 Generation of a New Raw Material Identification Number Ti1 During the formulation process, R&D identill@s new raw materials and generates RMIDs in BatchMaster. 722 A raw material ID number wiill be assigned to the raw material. The ID number will consist of two parts (e.g. RMSOOOMD!): 722.1 Use type designator consisting ofttinee letters, 7.221.1.1 RMS indicates intent for use in a dietary supplement. 7212.2 RMD indicates intent for use in a drug product. 722.1.3 RMC indicates intent for use in a cosmetic product. 7.2.4.4 RMP indicates intent for use in a pet product. 722..5.5 RMF indicates intent for use in a food product. 722.2. The use type designator is fbllowedl by a six digit sequential number. 733 R&D will define the naming for the raw material as follows: 733.1 The naming schemes defined herein are general guidelimes. All elements listed below may not be applicable to alll raw materials. 733.2 Fine chemicals or defined chemical composites 7.22.1 Common name 7.3.2.2 Trademarked name 7422.3 Concentratiom 7.533 Botanicals 7.5.3.1 Common name 7333.2 Sciemtific name 7.33.3 Plant pati 7333.4 Extract ratio or standardized concentration 7.33. Other critical designators (e.g. organic) 800 Raw Material Profile Creation 8,1 After R&D creates a new. RMID in BatchMaster. the critical amd preferred physical characteristics ofttne material will be provided to the Q@E Lab as needed. 822 R&D designates amy required or inherent properties of the RM (e.g. gluten thee, non- GMO, vegetarian) [SOP Standard Operating Ptocedure SOP No Rev Page | Raw Material Life Cycle amd CoA Challenge Process D-901 8 40f8 | 833 The Raw Material Profile will be created by the Q@G Laboratory with input from R&D and the information entered into BatchMister. 814 The Raw Matenid! Profile, which is divided into Release Spacifications, Sampling Requirements, and Purchasing Specifications, contains the following infonmatiom: 844.1 Document Header (same for each section) 8.4.1.11 Raw Material Name (as documented in the Raw Material Database) $44.3.3 Material Category (Botanical, Drug, Fine Chemical, etc.) $44.4.4 Approved fior use in designations (OTC, Human, Cosmetic, etc.) 844..5.5 Wamings (Allangem, Hygroscopic, ete.) 844.2 Release Spacifications are detenmined based om number of factors including regulatory requiremenis., use class, label claims, and customer tequimemmemtts.. The procedure for establishment of spacifications is outlined in D-902. 8414.3 Punciireasing Speaifications $44.3.1 For the required testing listed under Release Spauifications (Section $.4.2), tests that are critical to product perfonmamce are listed to assist purchasing in sourcing the raw material. 8443.2 For each critical test. a critical value is listed! for which amy raw material purcitasedl must sattisty. 844.3.3 For each critical test, a preferred value may be listed which indicates the desirable value for raw material purchasing. 814.4 Sampling Requirements $444.1 For ead test or group of tests, the amount of sample required to complete the test(s) is listed. $44.4.2 Two sample amounts are listed, The first is the amoumt required to perform alll testing included in a CoA challenge, while the second is the amount required to perfomm the reduced testing required after CoA challenge has been completed. $444.3 QE Work Order number. $444.4 R number. $444.5 Bin number. 8444.6 Delivered to Lab By. 8444.7 Date/TimeDativerect. [SOP Standard Operating Procedure SOP No Rev Page Raw Material Life Cycle and CoA Challemge Process D-9011 8 5 of 8 84414,8 PreqaxstiBy/Date. 8444.9 R&D Reviewed By/Date. 8.44.10 QE Lab Reviewed By/Date. 844111 Quality Approved By/Date:. 8.5 The RMMS is generated along with the RM Pirdfile and includes the following information: 8.5.1 Name of Raw Material and ID# 8.5.2 Name of the Manulfacturer or Distributor 8.5.3 Receiving Numiber (R-Numiber) 8.5.4 Date Received 8.5.5 Vendor Lot Number 8.5.6 Expiration Date $56.1 Upon successitll completion of the Col), challenge process an expiration date is assigned to the raw material lot number and entered into BatchMaster.. $55.6.2 If the mamufacturer ColA gives am expiration/retest datte for the material then that date is used. $5%6.3 If the manufacturer expiration date is less than one year from date of recaipt and a fulll Cof\ challenge is completed for release them the expiration date can be increased up to one year from date ofratiase. Flavorings: are typically extended no more than 30 to 90 days. 85.6.4 If no manufecturer expiration date is listed on the CofA, but the date of mamufacture is listed, them the raw material cam be assigned an expiration date for up to three years from the date of manulactune at the discretiom of @E Management. 85.6.5 After the expiration date, the material can be CofA challenged again as per D-303. Upon suoceséiul completion of the challenge, the material expiration cam be extended up to one year at the discretiom of QE management. 8.565511 When the raw material is released the QE Laboratory will emler the new raw material expiration into BatchMiaster. The R# and a dash # will be used to identify the number of times a material has been recertifial. A raw matedal camnot be recertified more than three times. [SOP Standard Operating Procedune SOP No Rev Page Raw Material Liffe Cycle and CoA Challemge Process D-901 8 60f8 $55.7 Required Testing 855.8 Required Metthod(s) 855.9 Release Specificatiom $5190 A space for entry ofttne testing result, 8111 A space to indicate whether the required testing passed or failed. $5112 Initials/Datie of the person entering the data. $614 3 Initials/Date of the person comfirming the acouraoy amd) completeness of the data. 85144 Ifmo expiration date is available, assign a default date of 12 months for stable chemicals and 3 months for flavorimgs, Other expiration dates may be used with scientific justification. If material is unstable, QE Laboratory management will determine a suitable expiration date based on applicable literature. 866 Once reviewed and approved, DC will maintain the original copy of the RM Profile for each RMID. A scan of the approved RM Profile will be stored in a shared file directory. 900 Revision of a Raw Material Profile Oil aA Change Control Request is not required for new RM Profile documents. 922. Revisions to existing RM Profils will be conducted through the Change Control process as outlined in SOP C-403. 100 Raw Material CoA Challenge Requirennenits 1hO. 1 The RM CoA Chalilemge process is included as part ofttne Vendor Qualification procedure per SOP E-601. 1hQ,2 CoA Challenge status Of incoming matetial will be detemmined by the QC Lab. communicated to the @G Samplers, and documented on Form D-901-Fi, Raw Material Testing Summary (RMTS). 1.3 A minimum of three unique lots pet manufacturer miist be challenged before the manufacturer is qualified. 10.4 After the mamufacturer iS qualified 10 supply the raw maiterid!, @ minimum of identificatiom is required for release. bO.5 If a RM is received amd does not meet spauifications, the CoA challenge snouild be repeated. 10G.6 If the supplier is undergoing increased regulatory scrutiny, the CoA challenge should be repeated. [SOP Standard Operating Procedure SOP No Rev Page Raw Material Lite Cycle and CoA Challenge Process D-901 8 7 of$ 100.7 Data generated during re-certificatiiom testing ola RM per SOP D-303 are not valid fior inclusion in the CoA Challenge process. 10%8 Once the fiull CoA challenge process is complete for a raw maitterial / manufacturer combination, am unabbreviated CoA chalienge is required on the first lot after a twelve month period trom the date of completion ofttne last CoA challenge. Depending on the frequency of raw material purchases from a manufacturer, fulll CoA challenges can be initiated at a greater frequency. Increased frequency olCoA challenges is determined by QE Management. 1100 CoA Approval, Testing, and Release of Raw Materials 11.11 Purchasing wiill sutniit a copy Of the manufacturer's CoA to QC lab for approval. Approvals are based on requirements outlimed in the RM Profile. Ifttme RM has not been previously purchased fnom the manufacturer, the purchase should also be approved by R&D. flbh.2 Testing is perfommed as directed in the RM Profile based on the CoA Challenge Status. 11.33 Ifa RM does not meeta spacification listed in the RM Profile, the material can be rejected and retumed to the vendor. i144 The completed amd approved RMTS and manufacturer's CoA are sulamitted to DC fbr archiving. 1200 Use of Raw Materials in Production 1211 Ms should be released by Quality prior to use in Production. 1k2.2 For dietary supplememits, pet products, and cosmetics, RMs may be used in Productiom at risk: however, alll RM testing must be completed and RMs released prior to release of the FP. 123.3 Additional testing requirements may be stipulated prior to @E Lab clearance of am RM based on RM vendor, risk, product, client request, etc. 13300 Release of Raw Materals 183.1 After all testing has besn succesShility completed, the manufacturer CoA and all associated data are combined into orre packet and submitted to DC for archiving. IB2.2 Afiter all testing has been completed successfully, the @E Lab will update the RM status in batch master to “released”. 14400 Attacihments 1h4.1 Attachment 1 = Example Documentt: Raw Material Profile [SOP Standard Operating Procedune SOP No Rev Page Raw Material Life Cycle and CoA Challemge Prousss D-901 8 8 of 8 15.0 Revision History | Revision | Date Desonription ofCHangss CCN By 0 | 0830/10 | New . ° | tOfi7412 | Updated R&D process. Added forms. Changed SOP title and format. - - Removed RNC. Removed R&D formuilaiion saction. Removed 2 OGiLI77I 7AI t3 | actions 6,0 and 7.0. Updated process for RMSTT. li-4e5 Re;ceeionin Updated fonrat. Added informatiom on test selection and specification 3 O3/28/t4 | sélection, Removed inforination regading standznd sdiattion and t4-0280 B.Jotinns referenced SOP D- 1@9. Referenced I)-202 for external lab testing. 4 ovasiite pea informatiom from SOPs D-302, D-90 tt, amd E-602. Updated 16-002| N. Zhang out of'date infonmation with present practices. ; o6/ig/16 | Adiélition Of Cosmutics oriteiia 1 SOP, Update RW chaliengs | 4 aynn 5 isles requirements. : Saciions 7.3.1 amd 9.1-Added a separate entry om the RMISIT for ° i ake 17 Manufacturer. RMSTT format is updated to reflect tltis change. ra- ne > . See 7 01/02/18 | Rewrite of SOP to reflect mew procedinre using Raw Material Profiles. 18-0008 S. Barnes Remove references to SOPs that are mow obsolete. Add references to 8 03/04120 | mew SOPs that are relevant. Update for consistemcy with current | CC20)0259 | S. Sassman practices.