1. Dominique Talley
Audit Exercise for BEC 575
Introduction:
On March 27th, 2015 a facility audit was completed on the campus of North
Carolina State University Centennial Campus. The location of interest was The
Golden LEAF Biomanufacturing Training and Education Center (BTEC). A detailed
desk audit was constructed using BTEC Standard Operating Procedures (SOPs),
executed records, and other important information shown to be of relevance to the
facility.
Beginning with the desk audit, the given executed records were closely
reviewed and compared to the list of SOPs to be followed. Personnel utilize SOP’s to
ensure tasks and procedures are followed properly. An auditor manufactures a list
of non-adherent lapses in compliance in which identify the specific item of non-
compliance, the SOP number, and the federal regulation that was violated. Some of
the same errors can be observed within executed batch records. More frequently
noted within executed records is the lack of clarity on charts and diagrams. Federal
regulations as they relate to the desk audit can be seen to fall into the category of 21

2. CFR Part 211.100. This section deals with the written procedures; deviations. No
personnel were directly interviewed for this paper portion of the audit.
Following the desk audit, the facility was closely audited. Few locations of
interest found within the facility were as follows; the warehouse, LS recovery room
#142, Chromatography Room (LS purification), and lastly the staging/autoclave.
Our guide, Josh Hankins provided us with a brief but detailed orientated tour of the
facility. Beginning in the warehouse, Erica Brown spent time briefly overviewing the
practices and protocol for the warehouse and all products. Erica, in substitution for
Eric Safarz, discussed the importance of the proper placement of products as it
relates to the status; released (cleared for use), and quarantined. All products that
the facility utilizes are shipped into the warehouse where it is reviewed and marked
“released” (meaning; that materials are ready for use). In the event that a product is
not received in good condition, or the wrong product is received, the items are sent
then sent back. Items amid negotiation are placed in a designated metal cage and
labeled as such until final decision on product is reached. My time in the warehouse
was spent reviewing all products; checking for proper labeling, and correct location.
Upon moving from the warehouse to LS recovery room #142, and in efforts to avoid
possible contamination and mitigate risk, proper dress was necessary. While
entering the area designated for gowning, a red light is illuminated to indicate
whether another door is open. To prevent cross contamination of air only one door
should be open at a time. This seemingly error-free system could not be monitored
during the audit due to malfunction. Once my colleagues and I were properly
gowned we were ushered into the “Clean Room” After departing LS recovery room,
Josh lead us into the Chromatography Room (LS purification) where we briefly
reviewed all equipment and the general status of the area. Lastly, we met with
Nathan Blackwell where we reviewed the staging area, as well as, auto clave. Due to
the small area we were able to observe/reviewed all products and equipment.
Between the multiple rooms within the facility viewed a few major observations
were noted, and outlined below.

3. Major Observations:
Overall issues within the facility could be grouped into the following
categories; lack of material control, labeling, and lack of space. Within the
warehouse, many items were misplaced; released items were located where
quarantined items typically could be found. In addition, quarantined items were
located in the rejection box, both of which fall under 21 CFR Part 211.142 violations.
Some product lacking labeling was said to be donated material. This donated
material had no specific location in the warehouse.
In addition, materials were stocked to capacity. Moving to LS Recovery Room,
another clean room, many cardboard boxes were found, in efforts to eliminate the
possibility of contamination cardboard boxes do not belong in clean areas, this
violates 21 CFR Part 211.80 “General Requirements” of the Control of Components
and Drug Product Containers and Closures guidelines. Cardboard boxes are
considered “dirty” and should only be in the warehouse of the facility. This same
problem can be observed in both the purification room and staging/auto clave. Due
to the guidelines that all clean rooms must follow, certain items are not to be within
the room. Many items were place in incorrect locations as well as various
extraneous materials. This violates the procedural steps of GL-004 SOP protocol.
In addition to material control another major observation observed was
labeling. Within in the refrigerator located in the warehouse, labeling to determine
the status of product was nonexistent. Items were not labeled as released or
quarantined. Continuing with the major observation of labeling, out of date spray
bottles were found in the LS Recovery room, violating 21 CFR Part 211.94 “Drug
product containers and closures”. In addition to the lack of labeling, many of the
spray bottles were refilled with unknown substance. The manufacturing label
possibly did not match the product within, this was unsure. In addition the
equipment status for calibration was observed to be out of date. With the out of date
status of this equipment there is a great possibility that error could occur in

4. production. In addition to the lack thereof of labeling, cheat sheets were found on
equipment. This violates the 21 CFR Part 211.160 “ Current Good Manufacturing
Practice for finished Pharmaceuticals, General Requirements” ; while they may hold
to be beneficial to the employee this is a violation of law.
Especially observed with the staging area and warehouse, the BTEC facility lacks the
necessary space to adequately hold all product and equipment. Product was
observed stacked on top of cabinets rather than within the cabinets. Additionally,
within the warehouse product was placed sporadically in refrigerator and freezer.
Continuing with the lack of space dilemma seen in the BTEC facility, within the
staging area chemical was stored in the same location that the equipment (scales,
etc.) was also being stored. This could ultimately result in contamination.
Specifically noted within the staging area was clutter. Due to such a small area and
high volume of product, the whole staging area seemed to be very cluttered.
Corrective Action:
Three major observations of lack of material control, labeling, and lack of
space were noted as it relates to the BTEC facility. Due to the noted lack of material
control, a supervisor could create an end of shift walk-through checklist. This list

5. would ensure that all employees prior to leaving each workday walk through their
designated area and ensure all materials are located in correct area as well as
labeled. This would eliminate the possibility of oversight. Labeling seemed to be a
major issue, as material enters the warehouse all items must be labeled
immediately. When personnel request product, labeling should also be revisited. In
addition, to eliminate the lack of space issue, removing materials not needed from
staging area would allow for more space. The staging area was very small and it may
be beneficial to move this location to a bigger area within the facility. Lastly, there is
a need for major overall organization. Materials need to be placed in designated
areas, and any material not being used must be returned to warehouse.
Appendix:
Desk Audit
Non-Compliance Document # (SOP) Section number of
21CFR part 211
Date entry format Pg. 1 GL-009 7.1.5 21 CFR Part 211.188
Incorrect Date Format Pg.
2
GL-009 7.1.5 21 CFR Part 211.188
Blank spaces not signed &
dated Pg. 2
GL-009 7.1.7 21 CFR Part 211.188
Blank spaces not signed &
dated Pg. 3
GL-009 7.1.7 21 CFR Part 211.188
No explanation for cross
out Pg. 4
GL-009 7.1.7 21 CFR Part 211.100
Cross out in Chart not
dated or signed Pg. 4
GL-009 7.1.7 21 CFR Part 211.100
All N/A spaces are not
initialed and dated Pg. 4
GL-009 7.1.7 21 CFR Part 211.100
N/A not written in chart
for Glycerol Pg. 5
GL-009 7.1.3 21 CFR Part 211.100
No explanation for cross
out in chart Pg. 5
GL-009 7.1.7 21 CFR Part 211.100
Numbers are not legible
Pg. 5
GL-009 7.1.1 21 CFR Part 211.100
No explanation or initial
for cross out in chart Pg. 7
GL-009 7.1.7 21 CFR Part 211.100

6. Blank spaces are not cross
out or initials and
explained Pg. 8
GL-009 7.1.7 21 CFR Part 211.188
Dates are not legible Pg. 8 GL-009 7.1.1 21 CFR Part 211.188
Inconsistent Ink Color Pg.
9
GL-009 7.1.1 21 CFR Part 211.100
Comment Section not
crossed out, no
explanation, no initials Pg.
11
GL-009 7.1.7 21 CFR Part 211.100
Inconsistent use of Ink
Color Pg. 12
GL-009 7.1.1 21 CFR Part 211.100
Comment Section not
properly crossed out with
initials Pg. 13
GL-009 7.1.7 21 CFR Part 211.100
Inconsistent use of Ink
Color Pg. 15
GL-009 7.1.1 21 CFR Part 211.100
Inconsistent use of Ink
Color Pg. 16
GL-009 7.1.1 21 CFR Part 211.100
Inconsistent use of Ink
Color Pg. 17
GL-009 7.1.1 21 CFR Part 211.100
Data not legible Pg. 18 GL-009 7.1.1 21 CFR Part 211.188
Inconsistent use of Ink Pg.
19
GL-009 7.1.1 21 CFR Part 211.100
No data, no explanation
Pg. 20
GL-009 7.1.7 21 CFR Part 211.188
Comment Section not
properly crossed out with
initials Pg. 22
GL-009 7.1.7 21 CFR Part 211. 188
Inconsistent use of Ink
color Pg. 22
GL-009 7.1.1 21 CFR Part 211. 100
All symbols not labeled Pg.
23
GL-009 7.1.7 21 CFR Part 211. 100
Comment section not
properly crossed out with
initials Pg. 23
GL-009 7.1.7 21 CFR Part 211.188
Facility Audit
Release item located
where quarantined items
located
Warehouse: Erica Brown;
GL-008 7.1.3
21 CFR Part 211.142
Quarantined item in Warehouse: Erica Brown; 21 CFR Part 211.142

7. rejection box
(communication with
supply)
GL-008 7.3.4
Item in quarantined
location without labeling
Warehouse: Erica Brown;
GL-008 7.2.2
21 CFR Part 211.130
Items in refrigerator
without labeling
Warehouse: Erica Brown;
GL-008 7.1.1
21 CFR Part 211.130
Items in freezer grouped
together, no separation of
quarantined items
Warehouse: Erica Brown;
GL-008 7.3.1
21 CFR Part 211.142
Donated material not
labeled
Warehouse: Erica Brown
GL-008 7.1.2
21 CFR Part 211.130
Red light to signify door
open constantly lit
Clean Room/ LS Recovery
Room #142
21 CFR Part 211.67
Holes in wall LS Recovery Room #142
GL-004: 7.4
21 CFR Part 211.67
Dry Chemical on floor LS Recovery Room #142
GL-004 7.4
21 CFR Part 211.67
Particle on floor LS Recovery Room #142
GL-004 7.4
21 CFR Part 211.67
Pressure gauge out of date
for calibration
LS Recovery Room #142
GL-004 7.3
21 CFR Part 211.68
Out of date on spray
bottles
LS Recovery Room #142
GL-004 7.3
21 CFR Part 211.94
Hoses wrapped on wall
incorrectly, allowing for
fluid to sit.
LS Recovery Room #142
GL-004 7.3
21 CFR Part 211.63
Cardboard located inside LS Recovery Room #142
GL-004 7.4
21 CFR Part 211.160
Expired dates on
equipment
Chromatography Room
(LS Purification)
21 CFR Part 211.94
No equipment labeling Chromatography Room
(LS Purification) GL-004
7.2
21 CFR Part 211.130
Cheat sheets on
equipment
Chromatography Room
(LS Purification) GL-004
7.3
21 CFR Part 211.160
Room status tag expired
(not used anymore)
Chromatography Room
(LS Purification)
21 CFR Part 211.137
Cardboard boxes located
on shelves
Staging (prep): Nathan
Blackwell GL-004 7.4
21 CFR Part 211.160
Tape for labeling on
product
Staging (prep): Nathan
Blackwell GL-004 7.2
21 CFR Part 211.130
Equipment not separate
from chemical
Staging (prep): Nathan
Blackwell
21 CFR Part 211.142

8. Labeling is lacking on
items
Staging (prep): Nathan
Blackwell GL-004 7.2
21 CFR Part 211.130
Calibration of scales only
done once in morning
Staging (prep): Nathan
Blackwell GL-004 7.3
21 CFR Part 211.67
Return of product not
labeled
Staging (prep): Nathan
Blackwell GL-004 7.2
21 CFR Part 211.130