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SEC Filings

10-Q
ATHENEX, INC. filed this Form 10-Q on 05/09/2019
Entire Document
 

Athenex GMP Specificatio

Exhibit 2 (p. 5 of 5)

 

 

Spec No.

Name

Rev

Set Name

Issuance Date

43 21 00

Process Pumps

0

Issue for Bid

10/12/2018

43 21 00.01_dat

Centrifugal Pump Data Sheets

0

Pricing Issue

8/31/2018

43 21 00.06_dat

AODD Pump Data Sheets

0

Pricing Issue

8/31/2018

43 21 00.07_dat

Waste Transfer Unit Data Sheets

0

PQ0013-0018

9/20/2018

43 21 00.07_sit

Waste Transfer Unit Submittal, Inspection, and Testing (SIT) Form

0

PQ0013-0018

9/20/2018

43 41 16

Plastic Tanks

0

PQ0013-0018

9/20/2018

43 41 16.01 _dat

Plastic Tanks Data Sheet

0

Process Spec Review II- 1 of 2

8/1/2018

45 53 01 01

General Requirements for Biopharm Equipment

0

PQ0013-0018

9/20/2018

45 53 01 10

Submittals, Inspections, and Testing Requirements

0

PQ0013-0018

9/20/2018

45 53 12 01

Biopharm Centrifugal Pump

0

PQ0013-0018

9/20/2018

45 53 12 03_dat

Peristaltic Pump Data Sheet

A

Pricing Issue

8/31/2018

45 53 12 03_SIT

Peristaltic Pump Submittals, Inspection, and Testing (SIT) Form

A

Pricing Issue

8/31/2018

45 53 12.03

Peristaltic Pump

A

Pricing Issue

8/31/2018

45 53 15 01

Biopharm Vessels

0

PQ0013-0018

9/20/2018

45 53 15 01._SIT

Biopharm Vessels Submittals, Inspection, and Testing (SIT) Form

A

PQ007-9&11

9/7/2018

45 53 15 01.dat

Biopharm Vessels Data Sheet

1

PQ007-9&11

9/7/2018

45 53 17 11

Biopharm Magnetic Drive Mixer

A

PQ007-9&11

9/7/2018

45 53 17 11_dat

Biopharm Magnetic Drive Mixer Datasheet

A

PQ007-9&11

9/7/2018

45 53 19 01_SIT

Transfer Panels Submittals, Inspection, and Testing (SIT) Form

A

PQ007-9&11

9/7/2018

45 53 19 05

Utility Panels

A

PQ007-9&11

9/7/2018

45 53 19 05._SIT

Utility Panels Submittals, Inspection, and Testing (SIT) Form

A

PQ007-9&11

9/7/2018

45 53 19 05.dat

Utility Panels Data Sheet

1

PQ007-9&11

9/7/2018

45 53 19.01

Transfer Panels

A

PQ007-9&11

9/7/2018

45 53 19.01.dat

Transfer Panels Data Sheet

A

PQ007-9&11

9/7/2018

45 53 19.21

Mix-Proof Valve Manifold

0

PQ0013-0018

9/20/2018

45 53 19.21_dat

Mix-Proof Valve Manifold Data Sheet

0

PQ0013-0018

9/20/2018

45 53 19.21_SIT

Mix-Proof Valve Manifold Submittals, Inspection, and Testing (SIT) Form

0

PQ0013-0018

9/20/2018

45 53 21 01

Biopharm Shell and Tube Heat Exchangers

0

PQ0013-0018

9/20/2018

45 53 21 01.dat

Biopharm Shell and Tube Heat Exchangers Data Sheet

A

Process Spec Review II- 1 of 2

8/1/2018

45 53 21 01_SIT

Biopharm Shell and Tube Heat Exchangers Submittals, Inspection, and Testing (SIT) For

A

Process Spec Review II- 1 of 2

8/1/2018

45 53 21 51

Temperature Control Unit Skid Assembly

A

PQ007-9&11

9/7/2018

45 53 21 51_SIT

Temperature Control Unit Skid Assembly Submittals, Inspection, and Testing (SIT) Form

A

PQ007-9&11

9/7/2018

45 53 21.16

Biopharm Point of Use Heat Exchanger

0

Pricing Issue

8/31/2018

45 53 21.16_dat

Biopharm Point of Use Heat Exchanger Data Sheet

0

Pricing Issue

8/31/2018

45 53 21.16_SIT

Biopharm Point of Use Heat Exchanger Submittals, Inspection, and Testing (SIT) Form

0

Pricing Issue

8/31/2018

45 53 21.51.01_dat

Temperature Control Unit Skid Assembly Data Sheet

0

PQ007-9&11

9/7/2018

45 53 25 02

Hygenic Cartridge Filters

1

PQ0013-0018

9/20/2018

45 53 25 02.dat

Hygenic Cartridge Filters Data Sheet

A

Pricing Issue

8/31/2018

45 53 25 02_SIT

Hygenic Cartridge Filters Data Sheet Submittals, Inspection, and Testing (SIT) Form

A

Pricing Issue

8/31/2018

45 53 54 11

GMP Parts Washer / Dryer

0

PQ001-PQ003

8/10/2018

45 53 54 11_dat

GMP Parts Washer / Dryer Data Sheet

2

AddendumtoProcessSpecUpdates

11/26/2018

45 53 54 11_SIT

GMP Parts Washer / Dryer Data Sheet Submittals, Inspection, and Testing (SIT) Form

0

PQ001-PQ003

8/10/2018

45 53 54.01

Clean in Place Skid

0

PQ0013-0018

9/20/2018

45 53 54.01_dat

Clean in Place Skid Data Sheet

0

PQ0013-0018

9/20/2018

45 53 54.01_SIT

Clean in Place Skid Submittals, Inspection, and Testing (SIT) Form

0

PQ0013-0018

9/20/2018

45 53 55 01

GMP Autoclave

0

PQ001-PQ003

8/10/2018

45 53 55 01_SIT

GMP Autoclave Data Sheet Submittals, Inspection, and Testing (SIT) Form

0

PQ001-PQ003

8/10/2018

45 53 55.01 dat

GMP Autoclave Data Sheet

0

PQ001-PQ003

8/10/2018

45 53 61 22

WFI Vapor Compression Still

0

PQ005-PQ006

8/20/2018

45 53 61 22.dat

WFI Vapor Compression Still Data Sheet

0

PQ005-PQ006

8/20/2018

45 53 61 22_SIT

WFI Vapor Compression Still Submittals, Inspection, and Testing (SIT) Form

0

PQ005-PQ006

8/20/2018

45 53 61.31

Pure Steam Generator

0

PQ001-PQ003

8/10/2018

45 53 61.31_dat

Pure Steam Generator Data Sheet

0

PQ001-PQ003

8/10/2018

45 53 61.31_SIT

Pure Steam Generator Submittals, Inspection, and Testing (SIT) Form

0

PQ001-PQ003

8/10/2018

45 53 61.41

Compendial Water Storage and Distribution

0

PQ005-PQ006

8/20/2018

45 53 61.41_dat

Compendial Water Storage and Distribution Data Sheet

1

PQ005-PQ006

8/20/2018

45 53 61.41_SIT

Compendial Water Storage and Distribution Submittals, Inspection, and Testing (SIT) Fo

0

PQ005-PQ006

8/20/2018

45 53 65 16

Water Pretreatment Skid

0

PQ005-PQ006

8/20/2018

45 53 65 16.dat

Water Pretreatment Skid Data Sheet

0

PQ005-PQ006

8/20/2018

45 53 65 16_SIT

Water Pretreatment Skid Submittals, Inspection, and Testing (SIT) Form

0

PQ005-PQ006

8/20/2018

45 53 97.60

pH Neutralization System

0

PQ0013-0018

9/20/2018

45 53 97.60_dat

pH Neutralization System_Data Sheet

0

PQ0013-0018

9/20/2018

45 53 97.60_SIT

pH Neutralization System Submittals, Inspection, and Testing (SIT) Form

0

PQ0013-0018

9/20/2018

 

 

 

1/30/2019

CONFIDENTIAL

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