Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 30July2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 45 pages
COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 02 Jul 2021FDA queries -CMC information and categorical exclusion for an environment analysis PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 4 REGARDING THE MANUFACTURING OF DRUG SUBS TANCE (DS) ............................ 5 QUERY 1 ................................ ................................…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 28July 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 6 pages
COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel electrophoresis PFIZER CONFIDENTIAL Page 1QUERY 1 Please describe the spiked materials used for evaluating the RESPONSE 1 090177e1979cc629\Approved\Approved On: 21-Jul-2021 16:20 (GMT) (b) (4) (b) (4) FDA-CBER-2021-5683-1149349 COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 23July2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 6 pages
Page 1 of 1Date: Food and Drug Administration Center for Biologics Evaluation and Research Sample Custodian 10903 New Hampshire Avenue W075 -G707 Silver Spring, MD 20993 -0002 cc: 125742 _0/ 0003 /FC Please consider this as an official request for batch release for the following product: License Name of Product : Type of Container: Storage Conditions: Marketing Authorisation Holder: Batch Number: Date of Filling: Expiry Date: Total Quantity: Site of Manufacture: Electronic Protocol Filename…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 16July2021 FDA QueriesRe: LRP template IR and Samples for STN 125742/0 PFIZER CONFIDENTIAL Page 1LRPTEMPLATE FOR STN 125742/0 : QUERY 1: The lot release protocols previously submitted in amendments 125742/0.4 (dated May 24, 2021) and 125742/0.10 (dated July 9, 2021) need to be modified to be templates for use for all lots submitted to CBER. L ot release templates should be a preset format th at does not state results. …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
BNT162b2 3.2.A.3.1.1 Nomenclature [ALC -0315] PFIZER CONFIDENTIAL Page 13.2.A.3.1.1. NOMENCLATURE [ALC -0315] Information on the nomenclature of AL C-0315 is provided in Table 3.2.A.3.1.1-1. Table 3.2.A.3.1.1-1. Nomenclature of ALC -0315 Nam e/code Description Company or Laboratory Code ALC -0315 : ALC -315) IUPAC Chemical Name [(4-Hydroxybutyl)azanediyl]di(hexane -6,1- diyl) bis(2- hexyldecanoate) Chemical Abstract Service Chemical NameDecanoic acid , 2-hexyl -, 1,1’…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
CERTIFICATE OF ANALYSIS PHARMACIA & UPJOHN COMPANYLLC (A SUBSIDIARY OF PFIZER INC) 7000 PORTAGE RD KALAMAZOO, MI 49001 -0199USAPage 1 of 2 Generated Date: 06-2021 Item: F000051489 Title: PFE-BNT 0.5MG/ML COVIDVX25X2ML GVL EUA Expiration Date: 31-Oct-2021 Date Of Manufacture: 27-May-2021 Specification: US EUA LIMIT LOT NUMBER: FD0809 ASSOCIATED LOT: FE3194, EY0564 Documentation is considered PROPRIETARY and is made available for business operations and review by employees and regulatory…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
CERTIFICATE OF ANALYSIS PHARMACIA & UPJOHN COMPANYLLC (A SUBSIDIARY OF PFIZER INC) 7000 PORTAGE RD KALAMAZOO, MI 49001 -0199USAPage 1 of 2 Generated Date: 06-2021 Item: F000051489 Title: PFE-BNT 0.5MG/ML COVIDVX25X2ML GVL EUA Expiration Date: 31-Oct-2021 Date Of Manufacture: 24-May-2021 Specification: US EUA LIMIT LOT NUMBER: FC3184 ASSOCIATED LOT: EP8663, EY0563 Documentation is considered PROPRIETARY and is made available for business operations and review by employees and regulatory…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
CERTIFICATE OF ANALYSIS PHARMACIA & UPJOHN COMPANYLLC (A SUBSIDIARY OF PFIZER INC) 7000 PORTAGE RD KALAMAZOO, MI 49001 -0199USAPage 1 of 2 Generated Date: 06-2021 Item: F000051489 Title: PFE-BNT 0.5MG/ML COVIDVX25X2ML GVL EUA Expiration Date: 31-Oct-2021 Date Of Manufacture: 29-May-2021 Specification: US EUA LIMIT LOT NUMBER: FC3181 ASSOCIATED LOT: FE3195, EY0567 Documentation is considered PROPRIETARY and is made available for business operations and review by employees and regulatory…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pharmaceutical Sciences Reference Standard CertificateWorldwide Research & Development STANDARD INFORMATION Compound Reference Standard Lot Reevaluation / Expiration Date Occupational Exposure Band OEB 404-MA Y-2023677365P-1G-A-010REF_STD_GENERIC Long Term Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 07-Jul-2021Primary Contact TESTS AND RESULTS Purity Purity FOOTNOTES DSPC: Storage at C Single use aliquot! 677365P-1G-A-010 Material is hygroscopic …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pharmaceutical Sciences Reference Standard CertificateWorldwide Research & Development STANDARD INFORMATION Compound Reference Standard Lot Reevaluation Date Occupational Exposure Band OEB 404-NOV-2021677315O-1G-A-010REF_STD_GENERIC Long Term Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 13-May-2021 TESTS AND RESULTS Purity Purity FOOTNOTES ALC-0315: Storage at C Per vendor, material can only undergo and should be discarded after lot 677315O-1G-A-010…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pharmaceutical Sciences Reference Standard CertificateWorldwide Research & Development STANDARD INFORMATION Compound Reference Standard Lot Reevaluation / Expiration Date Occupational Exposure Band OEB 425-NOV-2021677159P-1G-A-010REF_STD_GENERIC Long Term Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 01-Jul-2021Primary Contact TESTS AND RESULTS Purity Purity FOOTNOTES ALC-0159: Storage at C Single use aliquot! (reference for vialing protocol & …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pharmaceutical Sciences Reference Standard CertificateWorldwide Research & Development STANDARD INFORMATION Compound Reference Standard Lot Reevaluation / Expiration Date Occupational Exposure Band OEB 407-FEB-2025677100P-1G-A-010REF_STD_GENERIC Long Term Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 07-Jul-2021Primary Contact TESTS AND RESULTS Purity Purity FOOTNOTES Cholesterol: Storage at C Single use aliquot! 677100P-1G-A-010 Material is hygroscopic …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pharmaceutical Sciences Worldwide Research & Development Certificate of Analysis Material Type: Material Description or Name: Material ID: Pfizer Lot Number: DS-001477PF-07305885 Drug SubstanceActive Pharmaceutical Ingredient 21Y513C2501 Authorized By 09-Feb-2021 REGISTERED TESTS ACCEPTANCE CRITERIA RESUL T Appearance (Clarity) Clarity Appearance (Coloration) Coloration pH UV Spectroscopy Content (RNA Concentration) RT-PCR Identity of Encoded RNA Sequence Capillary Gel Electrophoresis RNA…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pharmaceutical Sciences Worldwide Research & Development Certificate of Analysis Material Type: Material Description or Name: Material ID: Pfizer Lot Number: DS-001477PF-07305885 Drug SubstanceActive Pharmaceutical Ingredient 21Y513C2401 Authorized By 09-Feb-2021 REGISTERED TESTS ACCEPTANCE CRITERIA RESUL T Appearance (Clarity) Clarity Appearance (Coloration) Coloration pH UV Spectroscopy Content (RNA Concentration) RT-PCR Identity of Encoded RNA Sequence Capillary Gel Electrophoresis RNA…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pharmaceutical Sciences Worldwide Research & Development Certificate of Analysis Material Type: Material Description or Name: Material ID: Pfizer Lot Number: DS-001477PF-07305885 Drug SubstanceActive Pharmaceutical Ingredient 21Y513C2301 Authorized By 10-Feb-2021 REGISTERED TESTS ACCEPTANCE CRITERIA RESUL T Appearance (Clarity) Clarity Appearance (Coloration) Coloration pH UV Spectroscopy Content (RNA Concentration) RT-PCR Identity of Encoded RNA Sequence Capillary Gel Electrophoresis RNA…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 16 pages
COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0 PFIZER CONFIDENTIAL Page 1LRP TEMPLATE FOR STN 125742/0: QUERY 1: Please submit a lot release protocol template for COVID -19 mRNA Vaccine for CBER review b y COB Friday , July 9, 2021. Please include the assay s performed and acceptance criteria for the drug product. RESPONSE 1 The Lot release protocol that included the assay s performed and acceptance criteria was …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 09July 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …