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SAMPLING RECORD TEMPLATE

In document validation protocol (Page 38-59)

DF-0531-01 Dissolution Tanks

2. SAMPLING RECORD TEMPLATE

 Purifying Plant

Sampling Point:

VHB 001 Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3

Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10

Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 17 Day 18 Day 19

Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 5 / 29

Sampling Point:

VHD 003 Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 6 / 29

Sampling Point:

VHD 007 Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 7 / 29

Sampling Point:

VHD 010 Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 8 / 29

Sampling Point:

VHD 011 Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 9 / 29

 Storage and Distribution

Sampling Point:

SV 541 001 Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3

Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11

Day 12 Day 13 Day 14 Day 15 Day 16 Day 17 Day 18

Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 10 / 29

Sampling Point:

SV 541 002 Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 11 / 29

Sampling Point:

SV 541 003

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 12 / 29

 Points of use

Sampling Point:

PU-5

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 13 / 29

Sampling Point:

PU-4

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 14 / 29

Sampling Point:

PU-3

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 15 / 29

Sampling Point:

PU-2

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 16 / 29

Sampling Point:

PU-1

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 17 / 29

Sampling Point:

PU-8

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 18 / 29

Sampling Point:

PU-9

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

Day 8 Day 9 Day 10 Day 11 Day 12 Day 13 Day 14 Day 15

Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 19 / 29

Sampling Point:

PU-6

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

Day 8 Day 9 Day 10 Day 11 Day 12 Day 13 Day 14 Day 15

Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 20 / 29

Sampling Point:

PU-11

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9

Day 10 Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 17

Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 21 / 29

Sampling Point:

PU-10

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5

Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13

Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 22 / 29

Sampling Point:

PU-7

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

Day 8 Day 9 Day 10 Day 11 Day 12 Day 13 Day 14 Day 15

Day 16 Day 17 Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 23 / 29

Sampling Point:

PU-12

Sampling Date

Sample taken by:

(Initials and signature)

Verify by:

(Initials and signature) Day 1

Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9

Day 10 Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 17

Day 18 Day 19 Day 20

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 24 / 29

Deviations

Description Affect the

validation study: Date / Sign.

Yes

No

Remarks

Final result: Conforms Non conforms

Performed by: Signature: Date:

Verify by: Signature: Date:

Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 25 / 29

In document validation protocol (Page 38-59)

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