CFR - Code of Federal Regulations Title 21
[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2013]
[CITE: 21CFR211]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart J--Records and Reports
Sec. 211.182 Equipment cleaning and use log.
A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under 211.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
[73 FR 51933, Sept. 8, 2008]
[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2013]
[CITE: 21CFR211]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart J--Records and Reports
Sec. 211.182 Equipment cleaning and use log.
A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under 211.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
[73 FR 51933, Sept. 8, 2008]
Equipment Name: Steam
Heat Sterilizer
Equipment I.D:
XX/SHS/001
Month: December
|
Date
|
Product/material
|
B. No.
|
Time
|
Activity
|
Done By
|
Checked By
|
Remark
|
|
|
From
|
To
|
|||||||
|
26/12/2013
|
70% IPA
|
IPA/ILS/1213
|
9.30
|
9.50
|
Cleaning
|
<Sign>
|
<Sign>
|
|
|
26/12/2013
|
NA
|
<Cycle No.>
|
10.00
|
10.30
|
Leak test
|
<Sign>
|
<Sign>
|
|
|
26/12/2013
|
BD Kit
|
<Cycle No.>
|
11.00
|
12.00
|
BD Cycle
|
<Sign>
|
<Sign>
|
|
|
26/12/2013
|
Filling component
|
<Cycle No.>
|
13.00
|
14.00
|
HPHV Cycle taken
|
<Sign>
|
<Sign>
|
|
|
26/12/2013
|
NA
|
NA
|
15.30
|
16.00
|
Preventive
maintenance
|
<Sign>
|
<Sign>
|
|
|
26/12/2013
|
70% IPA
|
IPA/ILS/1213
|
16.00
|
16.30
|
Cleaning
|
<Sign>
|
<Sign>
|
|
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