SURGE LAB.

(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Sr.
#
1.
2.
3.
4.
5.

6.
7.
8.
9.

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

OBSERVATIONS

RECOMMENDATION

REQUIREMENTS of cGMP
Poor
(No)

Inadequate

Satisfactory
(Yes)

Excellent

Are there appropriate temperature and humidity

controls and ventilation system?
Are joints sealed between walls, ceilings and floors?
Are the critical steps of manufacturing process
validated?
Is there appropriate air handling system to avoid
contamination & cross contamination?
Is any dedicated and self-contained facility provided
for production of highly sensitizing materials
Cephalosporin?
Are the Surfaces (Walls, floors, ceilings) exposed to
products, smooth and free from cracks and open
joints to avoid particulate matter shedding and
easy/effective cleaning?
Are drains equipped to prevent back-flow?
Does the lay out of equipment prevent the
contamination of drugs by other drugs, by dust and
by foreign material e.g. rust, lubricant etc.
Are the surfaces of equipment come in contact with
raw materials, in-process materials or finished
products, cleanable and made of corrosion resistant
Page 1 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

& non reactive material?

Page 2 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Sr.
#

Audit Date:_____________

REQUIREMENTS of cGMP

Auditor(s) 1)_______________2)_______________3)______________

Poor
(No)

OBSERVATIONS
Satisfactor
Inadequate
y
(Yes)

Recommendation
Excellent

Are the Labels attached to containers, equipment &

10. working areas, firmly affixed, unambiguous, indicating
the status like Quarantined, Accepted, Rejected,
Cleaned.
Does the Product Master Formula Contain,
a) Product reference code relating to its specification,
b) Statement of expected yield,
c) Statement of the processing locations & the
11.
principle equipment to be used.
d) Detailed step-wise processing instructions
including mixing time & temperature.
e) Instructions for in-process controls with limits.
f) Storage condition & precautions.
Does the formally authorized packaging instructions
for each product & pack size exist including in it;
a) A complete list of all packing materials with the
code or reference number relating to the
12.
specifications for each packaging materials,
quantities, sizes & types.
b) Description of packaging operation and equipment
to be used.
c) Details of in-process controls with instructions for
sampling & acceptance limits.
Page 3 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

13.

14.
15.

16.

17.

18.

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

Are the Procedure/SOPs and Records available for,

a) Describing details of batch (lot) numbering
system.
b) Assigning responsibility for sanitation and
describing the cleaning schedules methods,
equipments and materials to be used?
c) Equipment assembly and validation
d) Pest control.
Is any documented program and evidence available for
Self Inspection activity within Production department
and corrective actions taken?
Is the introduction of all or parts of earlier batches in to
a batch of same product at a defined stage of
manufacture authorized?
Are the checks on yield and re-conciliation of
quantities carried out to ensure that yields are within
limits? Whether yield deviations are recorded and
investigated or not?
Is the batch processing records for each processed
product maintained?
Is batch processing record based on relevant portions
of approved Master Formula and Processing
Instructions?
Are checks performed and recorded on Batch Record
before starting any process to assure that,
a) The equipment and work stations are clear of
previous products, documents and materials not
required for planned process.
b) Equipment is clean and suitable for use.
Page 4 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Sr.
#

Audit Date:_____________

REQUIREMENTS of cGMP

Auditor(s) 1)_______________2)_______________3)______________

Poor
(No)

OBSERVATIONS
Satisfactory
Inadequate
(Yes)

RECOMMENDATION
Excellent

Are the following information recorded on

Batch Record during batch processing and after
completion for batch.
a) Name of drug & Batch No.
b) Date & Time of commencement of
significant intermediate stages and of
completion of production.
c) Initials of operator of different significant
19.
steps of production and the person who
checked each of these operations.
d) Major equipment used.
e) In process controls and the initials of the
person(s) carrying them out and the results
obtained.
f) Notes on special problems including details,
with signed authorization, for any deviation
from Master Formula.
Are logbook kept with major and critical
equipment to keep record of validation,
20.
calibration, cleaning or repair operations
including dates and identity of people who
carried out these operations?
21. Is there facility of appropriate air lock, pressure
differential and dust extraction system within
processing areas to avoid contamination and
Page 5 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

cross-contamination?
Is there written procedure for sanitization of
22. pipes used for conveying distilled, de-ionized
or other water pipes describing the limits and
action to be taken for sanitization?
Is written program available indicating the
following cleaning procedures for the premises
and the equipment used in the production of
drug, namely:
a) Cleaning requirements applicable to all
production areas of plant.
b) Cleaning requirements applicable to all
processing equipment.
c) Cleaning intervals.
23. d) Cleaning materials, their concentration and
equipment to be used.
e) Disposal procedures for waste materials and
debris.
f) Pest control measures.
g) Precautions required to prevent
contamination of drugs when rodenticides,
insecticides and fumigation agents are used.
h) Microbial and environmental monitoring
procedures and limits in areas where
susceptible products are manufactured.
Are initial and continuing training records
24.
available for all personnel regarding CGMP and
hygiene instructions?
Page 6 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Sr.
#

25.

26.

27.

28.

Audit Date:_____________

REQUIREMENTS of cGMP

Auditor(s) 1)_______________2)_______________3)______________

OBSERVATIONS
Poor
Satisfactory
Inadequate
(No)
(Yes)

RECOMMENDATION
Excellent

Does the following system exist in Surge as per

cGMP?
If documentation (e.g. Master Formula, SOPs
etc) is handled by electronic data processing
methods, only authorized person should be able
to enter or modify data in computer and there
shall be a record of changes and deletions;
access should be restricted by passwords or other
means.
Is batch-number allocation recorded in logbook
for date of allocation, product identity, and size
of batch?
Are persons involved in sterile preparation
including those concerned with cleaning &
maintenance received regular training for correct
manufacture of sterile products, hygiene and
basic microbiology?
Are the conditions for producing, storing and
distributing water, validated to keep microbial
count within limits?
Are limits for microbial count for water
specified?

Page 7 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Sr.#

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

REQUIREMENTS of cGMP
Poor
(No)

OBSERVATIONS
Inadequate Satisfactory
(Yes)

Excellent

Recommendation

General
29.
30.
31.
32.
33.
34.

35.
36.
37.
38.

Do all operating departments Manufacturing / Packing have SOPs

for their responsibilities and operation.
Are these procedures, including changes, reviewed & approved by
the Quality Assurance Manager?
Does each department has it's procedures manual (with current
upto-date SOPs) readily available?
Is there formal audit team that performs periodic self audits?
Are there formal internal departmental inspections carried out by
concerned department Incharge?
Are audits conducted according to written procedures?
Does the audit procedure;
Define the audit team?
Contain an audit schedule?
Require that the audit results be sent to the Chief Executive / Head
of Technical Operation with copies to GM Plant & Production & the
concerned staff members?
Is there an autonomous Quality Assurance/Control unit with defined
responsibilities and authorities?
Does the Quality Control Unit has the authority and responsibility
to; Approve & reject all materials, labeling, bulk and finished
products according to Their specifications.
Is there system exist that prohibit eating, smoking and unhygienic
preaches not permitted in manufacturing area.
Page 8 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

39.

Is the restriction of entry of unauthorized personnel satisfactory?

All the personnel including those concerned with cleaning and
maintenance, employed in such area receiving regular training of
40. hygiene and basic elements of microbiology?
41. Are head gear totally close the hair and band?
Are a filtered air supply system of appropriate efficiency present to
42. maintain the positive pressure to the surrounding area of all
preparation?
43. Are maintenance of equipments is carried out in clean area?
44. Are new process validated?
45. Are all sterilization process validated and at what frequency?
46. Is there a validated system and use of filter?
Clean room (Personnel & Component)
Do all people entering the clean rooms receive regular specific
47. training in clean room gowning and aseptic techniques?
48. Is their a gowning qualification program for clean room operators?
Does the regular microbiological monitoring program for the clean
49. rooms includes sampling of hands, gowns, active air and surfaces?
Do all clean room operators participate in a media fill at least
50. annually?
What percentage of your class 100 environmental monitors showed
51. zero contamination on monthly basis?
Are class 100, 1000 and 10000 areas monitored for non-viable
52. particulates during manufacture?
Are all clean room operators banned from wearing cosmetics and
53. jewellery except a simple wedding band?
54. Is there a maximum permitted number of personnel permitted
within each clean room that has been qualified as part of media
Page 9 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

fills?
Are all the clean room tools (e.g. spatulas, spanners, etc)
55. specifically used for those areas and regularly sterilized?
56. Are all the environmental results trended?
Are interventions into the class 100 environmental recorded during
57. productions?
Media Fills
What percentage of routine media fills have passed first time during
58. annually?
Is your media fill acceptance criteria based upon the 95%
59. confidence limit of finding 1/1000 contamination level?
Are your products and media filled units both incubated for 14
60. days?
Are media fills ready by personnel specifically trained and qualified
61. to detect growth?
62. Are contaminated media fill units fully speciated?
Were media fills performed at least twice per year for each aseptic
filling line annually covering a logical selection of pack
63. presentations (e.g. Ampoule size etc)?
Does someone observe and record activities during media fills such
64. as intervention?
Environmental Monitoring Program
Does the environmental monitoring program include a check of
65. disinfectants being used?
Is all environmental data considered as part of final QA release of
66. finished sterile product?
Is the routine environmental monitoring program based upon data
67. obtained during room qualification?
68. If the environmental test results exceed the action limit is it reported
Page 10 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

and investigated as part of the batch deviation or OOS System?

Is clean room temperature and differential pressure continuously
69. monitored, recorded and alarmed?
Disinfectants
Have your clean room disinfectants and cleaning program been
70. comprehensively validated?
71. Are disinfectants used in clean rooms sterile filtered?
72. Is there a procedure to rotate disinfectants?
Are the purchased concentrated disinfectants released by the
73. Quality Unit?
Clean Rooms
Are all personnel and equipment airlocks entering clean rooms
74. inter-locked?
Do you prohibit the use of Formaldehyde for routine sanitization of
75. clean rooms?
Are glove ports or isolation techniques used to avoid un-necessary
76. interventions into class100 zones?
Are the HEPA Filters within clean rooms and localized laminar
77. flows integrity tested twice per year?
Are all product and component contact parts sterilized (not solely
78. sanitized) on a regular and defined basis?
Is there a differential pressure of between 10-15 Pa between rooms
79. of differing classification?
80. Is manufacturing carried out in clean area under laminar hood?
81. Are laminar calibrated?
Is every worker entering in the Sterile Area uses clean sterilized
82. protection garments?
83. Is there a separate laundry facilities present for such clothing?
Page 11 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

Water for Injection

84.
85.
86.
87.

Is water for injection used for final rinse of component and product
contact equipment wash cycles?
Are all WFI points of used routinely monitored as part of the water
sampling program?
Does the WFI sampling technique replicate production use?
Is the system presents in water supply system to prevent the
microbial growth for example constant circulation of 90oC or at
temperature validated to keep microbial count of water within the
limit?

Sterilizers
88.
89.
90.
91.
92.
93.
94.
95.

Were all of the sterilization and de-pyrogenisation cycles for

components and products validated annually?
Are all depyrogenisation cycles validated using appropriate
endotoxin reduction tests with at least a three log reduction of
endotoxin levels?
Are all HEPA filters located within sterilizers integrity tested at
least twice per year?
Have the endotoxin test including recovery been validated?
Are all sterilizing loads documented and covered by appropriate
validation work?
Do all Bio-indicators enumerated for each lot that is used?
Are product sterilizing filters integrity tested before and after
filtration?
Is the product filter integrity test equipment maintained and
calibrated at least annually?
Page 12 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

96.
Sr.
#

97.

98.
99.

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

Is sterilized bulk product filtered and filled within a pre-defined and

validated period?
REQUIREMENTS of CGMP

OBSERVATIONS
Poor
Satisfactory
Inadequate
Excellent
(No)
(Yes)

RECOMMENDATION

Are all equipment including Sterilizers, Air-filtration

system and water-treatment system subjected to
planned maintenance, validation and monitoring?
Check the documented evidence.
Are the sterile areas cleaned frequently in accordance
with a written program?
If sanitation is done with disinfectants whether more
than one type disinfectants are used or a single type of
disinfectant?
Are the following characteristics included in
validation of an aseptic process:
a) Use of nutrient media that support microbial
growth in trials to simulate aseptic operations,
sterile media fills and broth fills.
b) No. of personnel
c) Length of time.
d) Use of medium or media selected, capable of
growing a wide spectrum of microorganisms
including those that would be expected to be
found in the filling environment.
e) Trials should include a sufficient number of
productions units to give a high degree of
assurance that low levels of contamination if
Page 13 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

present, would be detected.

Sr.
#

REQUIREMENTS of cGMP

OBSERVATIONS
Poor
Satisfactory
Inadequate
Excellent
(No)
(Yes)

106.

Is each basket, tray or other carrier of products or

component clearly labelled with the name of material,
its batch no. and identification whether it has been
sterilized or not?
Whether the integrity of filter used for sterilization is
checked or not?
If yes, how and is there any record?
Does the following statement of CGMP comply in
Surge The same filer shall not be used for more than
one working day unless such use has been validated?
Are clean rooms classified according to the required
characteristics of air, in grade A, B, C & D or class
100, 1000, 10000 & 100000. ref: Federal standard
209E & ISO 14644-1 Part 1?
Is sterile filling performed in clean room class 10 (LFH
Grade A) or class 100 (Grade A)?
Is the air velocity of Laminar flow in Sterile filling >
0.30 + 20% M/S or 90 + 20% F/Min?
Are the air changes sterile filling room > 20 AC/HR?

107.

Is the air flow pattern of sterile filling room checked

100.

101.
102.

103.
104.
105.

RECOMMENDATION

Page 14 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

periodically?

Sr.
#

108.
109.
110.
111.
112.
113.
114.

REQUIREMENTS of cGMP

OBSERVATIONS
Poor
(No)

Inadequate

Satisfactory
Excellent
(Yes)

RECOMMENDATION

Are the products being manufactured, sterilized

terminally, through filtration or aseptically
processed as per product & area protocol?
Is the entry of ill and unauthorized personnel &
Jewellery / cosmetics restricted in sterile areas?
Are the workers involved in sterile filling, wear
sterilized, protective, non shedding & Specified
uniforms?
Is the separate laundry facility provided for washing
for sterile uniform to avoid cross contamination?
Is distilled water used for manufacturing stored at
80 C with constant circulation for 24 hours & loops
systems?
Are the filled products, sampled & tested for
sterility & pyrogen before final release?
Is the filling proceeded after having Q.C approval
for verification of sterilization, Area monitoring
results and utilities back up?

115. Entry of personnel and goods through air locks.

Page 15 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

116.

Sr.
#

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

SOPs in local language are displayed at different

spots/locations.

OBSERVATIONS
REQUIREMENTS of cGMP

RECOMMENDATION
Poor
Satisfactory
Inadequate
Excellent
(No)
(Yes)

117. Monitoring of positive pressure and pressure

7 differential during operation and record available.
Inter door locking system available for dry heat &
118.
moist heat sterilization
In compounding product filtration starts after
119.
permission of QC.
Audio warning system available in case of positive
120.
pressure failure in Vial/Amp. filling areas.
121. Calibration of balance before start of powder filling.
Wearing of specified sterilized lint and fiber free
122.
uniform in aseptic filling areas.
Verification of sterilization graphs before start of filling
123.
operations.
Proper setting of sterilization temperature, time,
124.
leakage & cooling cycle.
Proper storage and identification of product and its
125.
status.
126. Internal/External calibration as per determined
Page 16 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

frequencies and record available.

Page 17 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

Sr.
#

Audit Date:_____________

REQUIREMENTS of cGMP

Auditor(s) 1)_______________2)_______________3)______________

OBSERVATIONS
Poor
Inadequate
(No)

127.

128.

129.

Satisfactory
(Yes)

RECOMMENDATION
Excellent

Does the formally authorized packaging

instruction for each product & pack size exist
including in it,
a) A complete list of all packaging materials
with the code or reference number relating to
the specifications for each packaging
materials, quantities, sizes and types.
b) Description of packaging operation and
equipment to be used.
c) Details of in-process controls with
instructions for sampling & acceptance
limits.
Do the finished product contain following
information:a) Name of Drug. b) List of ingredients with
quantities c) Warnings
d) Batch No. Mfg. & Expiry Date e) Storage
conditions, direction for use.
Are the following information recorded on Batch
Record during batch processing and after
completion of batch.
a) Name of drug & batch no.
b) Dates & times of commencement of
significant intermediate stage and of
Page 18 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

130.
131.
132.

133.
134.

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

completion of production.
c) Initials of operator of different significant
steps of production and the person who
checked each of these operations.
d) Major equipment used.
e) In-process controls and the initials of the
person(s) carrying then out and results
obtained.
f) The amount of drug obtained at different
stages of manufacture.
g) Notes on special problems including details,
with signed authorization, for any deviation
from Master Formula.
Are the unused batch-coded packaging materials
destroyed and destruction recorded upon
completion of packaging operation?
Are finished products held in Quarantine until
release?
Are the checks on yield and re-conciliation of
quantities carried out to ensure that yield is
within limits? Whether yield deviations are
recorded and investigated or not?
Are all materials, bulk containers, equipments
and rooms are labeled and identified during
processing with and indication of material or
product being processed to indicate information
about material & processing stage?
Is the following clause of CGMP being followed
during packaging activity? Attention shall be
Page 19 of 20

SURGE LAB.
(PVT) LTD.

F-10-02 (A)

CHECK LIST FOR TECHNICAL AUDIT

REV. NO.: 1

Issue Date:
19.10.2009

Audit Area: Production

Audit No.:__________

135.

136.

137.

138.

139.

Audit Date:_____________

Auditor(s) 1)_______________2)_______________3)______________

given to minimizing the risk of crosscontamination, mix-up, or substitution and

different products shall not be packed in close
proximity unless there is physical segregation.
Whether the name and batch number of the
product being handled is displayed at each
packaging line or not?
Is there any evidence of record available which
reflect that printing operations (e.g. Code No. or
Expiry Date), especially printing by hand is
checked at regular intervals?
Is each basket, tray of other carrier of products
or component clearly labeled with the name of
material, its batch no. and identification whether
it has been sterilized or not?
Is the equipment and work station are clear of
previous products, documents or materials not
required for the planned process and that
equipment is clean and suitable for use before
starting any process.
Are the on line packing checks are performed,
and recorded, before & during packaging? (Line
Inspection Sheet)

Page 20 of 20