SHARIF PHARMACEUTICALS LTD.

Rupganj, Narayanganj

SELF-INSPECTION CHECKLIST (Department wise)

Serial Department: Production Remarks

No.
1 Are appropriate protective apparel required?

2 Is there gowning SOP for production staff?

3 Are staffs instructed to report health or medical problems that may have an
adverse effect on the product?

4 Do adequate drains exist? Are they designed with an atmosphere break to prevent
back-siphon age from sewer?

5 Does the design of the facility achieve a unidirectional flow of materials, personnel,
product and waste so as to avoid crossover of clean and dirty(infectious) material?

6 Is the lighting provided adequate for the conditions necessary for the work being
conducted in the area?

7 Is the facility designed and constructed to permit production in campaigns?

8 Has campaign changeover been validated (effectiveness of changeover)

9 Do washing facilities include: Hot and cold water?/ Soap and detergent?/
10 Clean toilet facilities that are easily accessible to working area
11 Clean hand drying facilities?
12 Are the premises satisfactory with
respect to: Neatness and cleanliness/State of repair, e.g. paint work, cracks
in floors, ceiling or walls, door seals ,etc/Exposed piping or electrical wiring?
13 Blocking of air ducts?
14 Equipment blocking corridors or exists?
15 If fumigation procedures are used, is the facility designed to permit effective
fumigation?
16 Is room temperature and humidity effectively controlled?
17 Clean steam : Is clean steam used for sterilization of product contact surfaces? /Is the
distribution system constructed of stainless steel treated to prevent corrosion and
sloped for drainage?
18 Are steps taken to prevent any substances required for operation, such as lubricants or
coolants, from coming in contact with in-process or finished products?
19 Are equipment and utensils cleaned, maintained and sanitized as appropriate to prevent
malfunction or cross- contamination?
20 Are piping systems, valves and vent filters properly designed to facilitate cleaning and
sterilization? NOTE: Maintaining closed systems through the use of “clean in place”
and “sterilize in place” if preferable
21 If a component/material is transferred to a new container, is the new contained
identified with
22 The container is properly identified? The components/material are added in

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 the batch by one person and verified by a second person? Are actual yield and
percentages of theoretical yield determined at the conclusion of each phase of
operation with documentation of any losses?
23 Are all containers, lines and major equipment identified at all times production for
content and phase of operations?
24 Record Signed by the person performing the task (and, for all critical steps, by the
person checking it)? Retained and available for inspection at least 2+1 years after the
expiry date of the lot/batch?
25 Identification of packaging materials, containers, closures used? Inspection of the
processing area before and after use? For rejected lots/batches, a record of disposal or
reprocessing? A BPR review document or checklist describing the review process
26 The yield obtained a different stage of manufacture, both actual measured
values and as a percentage of the expectation? A record of each step followed? A
record of all in-process control samples taken and of the results obtained?
27 Is there an appropriate noise control system? Is emergency power available in the
event of a power failure?
28 Are there SOPs written and approved for all manufacturing and testing activities? Is
there a system for distribution of SOPs and for revocation of outdated SOPs?
29 Are SOPs available for the labeling and packaging operations for equipment
and material delivery to the floor and are these easily accessible to the operators?
30 Are labeling and packaging operations properly physically segregated to
prevent mix-up of product or packaging materials?
31 Is there adequate on-line control of the labeled or packaged product including
the quality of printed text?
32 Is the name, strength and batch number prominently displayed at each operation?
33 Is there a specification for permissible reconciliation limits and action to be
taken in the event of exceeding these?
34 Is there a quality control mechanism for assigning lot numbers and expiry dating prior
to labeling operations? Are samples of printed labels and packaging materials used for
the batch kept with the records? Is there a segregated and secure quarantine storage
area for finished goods awaiting QC release?
35 Are there standard operating procedures for decontamination of process equipment and
facilities? Have these procedures been validated and is the performance monitored?
36 Is there a pest control programme ?
37 Are pesticides used? Is their use controlled so as to avoid product contamination?
38 Routine evaluation of the effectiveness of disinfectants and cleaning agents, and
chronological record of the agents used?
39 Validation for effectiveness of cleaning/sanitation, and validation of removal of
residual cleaning/sanitizing agents?
40 Is all labeled product accounted for including those destroyed during and at the
completion of the operation? Is there an inspection of the line made packaging
operation? Is it documented and signed by the responsible person?
41 Record of temperature and humidity control / log book of machine/cleaning
Department: Quality Control
1 Is room temperature and humidity effectively controlled?
2 Are cleaning and sanitizing agents validated and approved for use by QC?
3 Are there approved specification for all starting material or raw material used in
the manufacturing process and are they released by Quality control?
4 Routine monitoring of stability (viability / purity)?
5 Are criteria for microbial limits, physico-chemical characteristics and endotoxins
established for water systems and are effective measures taken when limits are
exceeded?
6 Are all autoclaved and dry heat sterilized items marked with heat sensitive indicators?

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7 Are reagents, culture media, etc. properly labeled, preparation recorded in lab books
and expiry dates given?
8 Are all reference reagents kept secure, properly stored, identified and their integrity
maintained?
9 Are the tests results of all reference and standards analyzed at appropriate intervals for
statistical variation from the expected value?
10 Are the accuracy, sensitivity, specificity and reproducibility of test methods
established, documented, validated and subject to regular review and updating?
11 Is there a written testing programme designated to assess the stability characteristics of
each product to determine the appropriate storage conditions and expiration dates?
12 Is there monitoring of air for microbes? /Is there monitoring of air for particulates? Is
there monitoring of surfaces for microbes?/ Is there monitoring of compressed gas
for particulates?

13 Is the stability of the final products and, if applicable, of the intermediates

monitored? Is there a system for reprocessing of unsatisfactory and returned products,
subject to prior approval by quality control?
14 Are all QC tests validated? Does the QC laboratory have SOPs describing sampling,
testing, documentation and précised criteria for release?
15 Are specifications, standards, sampling plans, test procedures or other Laboratory
control mechanisms including any revision, reviewed and approved by Quality
Assurance? Are any deviations from these specs, standards, etc. recorded and
justified? Retest policy, indentifying the rationale and criteria for retests, number of
samples, and the documentation required? A comprehensive calibration program that
includes calibration/certification intervals, acceptance criteria and provisions for
remedial action?
16 Is reconciliation performed to ascertain the number of labels issued, used and,
if applicable, returned to stock? Is the data recorded on the packaging batch records?

17 Is there monitoring of water for microbes and endotoxins?Is there a defined schedule
for environmental monitoring?
18 Are there sampling procedure ?
19 Are the following information on each sample taken : Name of person who performed
sample/ Number of samples taken/Number of container sampled ?

Department: Quality Assurance

1 Is there an organizational chart?
2 Are there job descriptions for key / all personnel?
3 Are there on the job training procedures for new employees
4 Are training and education records available?
5 Does a GMP training programme exist and followed ?
6 Are there specs and written procedures for the operation of the systems, sampling plan,
sites monitored and alert and action levels defined
7 Are definitive action steps taken to resolve conditions that are out of specification?
8 Are high-efficiency particulate air (HEPA) filters tested for integrity, at least annually?
9 Are HEPA filters terminally located? Are ductwork materials impervious to
disinfectants that may cause corrosion? Are duct work and filters located outside the
clean rooms?
10 If fumigation procedures are used, is the facility designed to permit effective
fumigation? Is the number of air changes per hour adequate for defined areas? Is the
air flow adequate? (Minimal pressure differential (1.21mm H2O) maintained? Air
supplied through HEPA filters? (Terminal filters should be employed for final
formulation and filling activities

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11 Sterile processing: Smooth, hard non-particulate generating cleanable floors, walls and
ceiling? Able to withstand cleaning, disinfecting reagents? No horizontal pipes of
conduits located over exposed components, in-process material, and production or
product contact surfaces?
12 Environmental controls, e.g. temperature, humidity and viable and non-viable
particles? Are there specifications for these controls? Has the system been validated?
13 Environmental monitoring system, e.g. temperature, humidity and particulates?
Fixtures (electrical outlets and lighting, etc.) flush mounted and sealed to prevent air
leakage, water access?
14 Appropriate air flow design including segregated air systems for different aspects of
the processing, e.g fermentation and filling? The ability to maintain the appropriate
pressure differentials between work areas with different Grades of air?
15 Is the aseptic manufacturing area cleaned according to a validated procedure? Is it
followed? Is the cleaning data recorded
16 Are autoclaves and sterilizing ovens fitted with effective, proper air filters HEPA
filters used for the ovens. Are there written procedures (SOPs) for cleaning and
maintenance of equipment and utensils and are they followed? Defined schedules for
cleaning and maintenance?
17 Instruction for protection of clean equipment from contamination?
18 Does the MF (master formula )adequately describe the complete production process?
19 Are all deviations from SOPs documented and subject to review by QA/QC for
approval or corrective action?
20 Are specifications, standards, sampling plans, test procedures or other Laboratory
control mechanisms including any revision, reviewed and approved by Quality
Assurance? Are any deviations from these specs, standards, etc. recorded and
justified? Retest policy, indentifying the rationale and criteria for retests, number of
samples, and the documentation required? A comprehensive calibration program that
includes calibration/certification intervals, acceptance criteria and provisions for
remedial action?
21 Is there a retention sampling system? Does the retention sample quantity consist of at
least twice the quantity needed to perform all required tests (except for sterility and
pyrogens)? Any retention samples of each lot of final product stored under conditions
consistent with product labeling? Are these samples at least visually examined
annually for evidence of deterioration? Is this recorded?

22 Are there records for: All materials used/All standard operating procedures/Each lot
and/or batch processing and distribution /All complaints and their investigation/All
equipment, including cleaning, maintenance and validation? /Cleaning, maintenance
And environmental control of the premises?
23 Is there a system for regular self- inspection of each manufacturing and test area? Are
the inspections followed up to ensure that appropriate action was taken to correct
deficiencies?
24 Are sewage, trash and other effluent disposal system adequate ?

Department: Product Development

1 Is room temperature and humidity effectively controlled?

2 Ingredients of finished products should be in permissible range

3 Quality of product followed as per pharmacopoeia.

Lab batch / pilot batch will meet the stability study
Department: Warehouse
1 Does the building design prevent the entry of insects, vermin and other animals ?Its
controlled system is followed effectively?

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2 Is room temperature and humidity effectively controlled?
3 Is there a quarantine and release system? Are the conditions of storage evaluated? Are
expiry dates given and is there a retest policy? Are rejected materials properly
segregated from acceptable material?
4 Characterization according to the WHO TRS relevant to the product? Adequately
segregates storage to avoid mix-up or cross-examination with other material?
5 Are dispensing/addition operations adequately supervised in that each component
/material dispensed is examined by a second person to ensure/The component/material
was released by QC?
6 Are standard operating procedures for the receipt, sampling and testing of packaging
materials available? Are incoming materials stored in controlled areas until released
from quarantine?
7 Are control or reference numbers assigned to each lot for traceability and control
purposes? Are released materials secured in controlled areas and is inventory
maintained
8 Are released materials secured in controlled areas and is inventory maintained
9 Do records allow rapid identification of all customers who have received any amount
of an identified lot/batch? Are records kept on the time, temperature and other
conditions of storage before distribution?
10 Do records show the date, quantity, and mode of package and dispatch of each
lot/batch to the customer?
11 Are there standard operating procedures for the storage of released finished product to
the dispatch area? Are standard procedures available for warehousing?
12 Are standard procedures available that describe the shipping, final transit conditions
and instruction for storage through the distribution chain, especially the cold chain?
13 Are records detailed and retrievable so that a rapid recall of any particular lot is
achievable? Is the recall process delegated to the responsible person? Are records
maintained for 2+1 years after the expiry dates?
14 Are warehouse lighting & ventilation adequate ?
15 Is there any program for general house keeping ?
16 Are there different colors of labels : quarantine/under test/released/rejected ?
17 Is there a stock rotation program ?
18 Is exterior storage area available for solvents, inflammable and hazardous materials ?
19 Expiry date, retest date, date released/rejected ,Analysis No. will be on QC label
20 Is there SOP of weighing area ?
Are lighting, ventilation & cleanliness adequate ?
Is there temperature & humidity control record ?
Is protective clothing including gloves, caps, masks etc available during the weighing
operations ?
Is there danger of cross contamination during weighing ?
Is there any dust extraction system in the weighing area ?
Are the scales calibrated regularly and record maintained ?
Are the utensils used for weighing properly cleaned after use ? Are the utensils kept in
a suitable place free from contamination?
Are raw-materials for each batch properly identified and segregated after weighing.

Department: Engineering & Maintenance

1 Is there a planned maintenance program on each system? Is it followed?
2 Are definitive action steps taken to resolve conditions that are out of specification?
HVAC system

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3 Are pre-filters present in heating, ventilation and air-conditioning (HVAC) systems
and replaced on a routine basis?
4 Are high-efficiency particulate air (HEPA) filters tested for integrity, at
least annually? Are HEPA filters terminally located?
5 Are ductwork materials impervious to disinfectants that may cause corrosion?
6 Are duct work and filters located outside the clean rooms?
7 Is the number of air changes per hour adequate for defined areas?
8 Is the air flow adequate? (Minimal pressure differential (1.21mm H2O) maintained?
9 Is room temperature and humidity effectively controlled?
10 Compressed Air: Is the air supply free from oil? Is the air supply filtered through a
sterilizing grade air filter? Is humidity controlled?
11 Is the distribution system constructed of stainless steel treated to prevent corrosion and
sloped for drainage?
12 Are support system designed and validated to assure integrity of the characteristics of
in-process material and final products?
13 Is there a system to report, investigate and record all deviations from specifications or
malfunctioning of equipment?
14 Are equipment surfaces that contact components or products of a non- interactive
nature?
15 Are process pipelines or service lines whose contents come in contact with products or
product contact surfaces sloped to allow proper drainage?
16 Are there preventive maintenance programs and consistent records of work
performed?
17 Has each phase of the production process been validated according to an approved
validation protocol?
18 Are suitable precautions taken to maintain aseptic conditions during the filling
process? Is each filling process validated by a simulated media fill?
19 Is there bioburden monitoring of starting, raw, and in-process materials before
sterilization? Are filters used for sterile filtration integrity tested before and after use?
20 Is there a system for validation and regular revalidation of all equipment, including
revalidation after repairs? Is there a system for calibration of all instruments?
Department: HR & Administration
1 Does a Induction/ regulation of HR training programmes exist for new employees?
2 Is trained personnel available for first Aid treatment
3 Annual update for all staff with job description?
4 Are records maintained for health check-up
5 By written procedures? Schedule of leave/payment facilities
6 Is there a medical monitoring programme to ensure protection of staff and product
7 To ensure hygienic food /refreshment
8 Training of Security on Checking and fire fighting
9 To make cleaning schedule of toilet / shoe rack/ change room & to implement it.
10 Dress washing schedule in laundry & ensure transport facilities
11 Execute building maintenance
12 Is there adequate fire fighting programme
Department: Management Representative
1 Execution of Quality objective/KPI
2 To Establish a built in GMP system to manufacture a drug

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